DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI)

SAN DIEGO, June 1, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that two posters updating results from the company's two Phase 2 clinical trials of VAL-083 will be presented at the 2020 American Association for Cancer Research Virtual Annual Meeting II to be held June 22-24, 2020.

Details regarding the posters to be presented in the Phase 2 Trials in Progress session are as follows:

Title: "Phase 2 trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"
Lead Author: Dr. Zhong-Ping Chen, Sun Yat-sen University Cancer Center
Poster Number: CT273
Summary: This poster will include data from the company's ongoing Phase 2 trial of VAL-083 being conducted at Sun Yat-sen University Cancer Center as a first line therapy, and includes updates on enrollment, safety and efficacy.

Title: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent or adjuvant setting"
Lead Author: Dr. Barbara O'Brien, M.D. Anderson Cancer Center
Poster Number: CT272
Summary: This poster will include data from the company's ongoing Phase 2 trial of VAL-083 being conducted at M.D. Anderson Cancer Center as a treatment in the recurrent and adjuvant settings, and includes updates on enrollment, safety and efficacy.

Additional posters relevant to VAL-083 to be available from the conference include:

Session: Mechanisms of DNA Damaging Therapeutics 
Title: "Dianhydrogalactitol (VAL-083) synergizes with topoisomerase inhibitors to overcome homologous recombination repair activity in glioblastoma and prostate cancer cells"
Poster Number: 1369

Session: DNA-reactive Agents and Other
Title: "Dianhydrogalactitol (VAL-083) exhibits strong efficacy in GBM tumors with different (epi)genetic background and treatment history"
Poster Number: 5231

All abstracts can be accessed via https://www.abstractsonline.com/pp8/#!/9045.

About VAL-083
VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083's anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at: 

SAN DIEGO, March 26, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced that it has received a listing extension from the Staff of the Listing Qualifications Department of The Nasdaq Capital Market LLC (Nasdaq).  The extension grants the Company until September 21, 2020 to regain compliance with the $1.00 Minimum Bid Price requirement for continued listing on Nasdaq. 

As previously disclosed on a Form 8-K filed on September 27, 2019 with the U.S. Securities and Exchange Commission, on September 26, 2019, the Company received a written notice (the Initial Notice) from the Nasdaq Staff indicating that the Company was not in compliance with the $1.00 Minimum Bid Price requirement for continued listing on Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was afforded an initial period of 180 calendar days, or until March 24, 2020, to regain compliance. The Company was unable to regain compliance with the $1.00 Minimum Bid Price requirement, which required the Company to demonstrate compliance for a minimum of ten consecutive business days. Subsequently, on March 25, 2020, the Company received an additional written notice notifying that while the Company had not yet regained compliance with the $1.00 Minimum Bid Price requirement, the Nasdaq Staff has granted an additional extension of 180 calendar days to September 21, 2020 to regain compliance with the Minimum Bid Price requirement.

SAN DIEGO, March 4, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced it has exceeded 50% enrollment in the adjuvant arm of the Company's ongoing Phase 2 clinical study investigating adjuvant treatment (pre-temozolomide -- or TMZ – maintenance therapy) of MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083. The 24-patient, open label study arm has now enrolled 14 patients and continues to enroll at an encouraging rate.

The adjuvant arm of the Phase 2 study of VAL-083 being conducted at the MD Anderson Cancer Center (MDACC) is designed to enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. 

"The pace of enrollment for the adjuvant arm of the study has been very encouraging and we hope to see both that arm, and the recurrent arm continue to enroll patients steadily. We will continue to provide updates as they become available," commented Saiid Zarrabian, DelMar's Chief Executive Officer. "In the meantime, having completed enrollment of our first-line study, we continue to anticipate an initial data readout before the end of August 2020."

The Company's second study arm being conducted at MDACC is the recurrent trial arm, which is enrolling patients who have typically been heavily pre-treated with TMZ prior to disease recurrence. In the recurrent setting, the Company previously announced that MDACC had approved up to 35 additional patients to this recurrent GBM study at a dose of 30 mg/m2, allowing for a total of up to 83 patients to be enrolled. To-date, 68 recurrent patients have been enrolled in the recurrent arm. DelMar is actively enrolling patients for both trial arms of the clinical study at MDACC.

SAN DIEGO, Feb. 19, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced it has enrolled and begun dosing the final patient in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM). The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

"We are very pleased to have enrolled and started dosing our final patient in this important study. This earlier than predicted full enrollment is encouraging and will allow an earlier topline data readout," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study's principal investigator. "The enrollment of the final patient also provides us the opportunity to corroborate the preliminary data we've recently published, which supports the possibility that VAL-083 can provide a new and valuable treatment option in this difficult-to-treat indication."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population. 

"Having completed enrollment of our first-line study ahead of schedule, we expect to complete analysis for the topline data in our most important Phase 2 trial for first-line GBM patients earlier than anticipated.  We are optimistic that we will receive the initial data readout before the end of August 2020," commented Saiid Zarrabian, DelMar's Chief Executive Officer. "In the meantime, we continue to rapidly advance our other Phase 2 program in the adjuvant and recurrent settings for VAL-083 at MD Anderson Cancer Center and look forward to providing further updates on the progress of our ongoing open label GBM trials at upcoming scientific meetings."

DelMar has been monitoring the coronavirus situation in China.  Based on discussions with our principal investigator at SYSUCC, we believe the coronavirus outbreak will not have a significant impact on our patient treatment timeline.

In addition to the Phase 2 clinical trial in first-line treatment, DelMar is conducting an additional two-arm Phase 2 clinical trial in GBM. The adjuvant arm, which initiated in late 2019 will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. The second arm treats patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled.  Both arms are being conducted at the University of Texas MD Anderson Cancer Center.

SAN DIEGO, Feb. 13, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced its financial results for the three and six months ended December 31, 2019 and provided a corporate update.

"We are pleased with the pace of progress of both trials, which in some cases have enrolled patients faster than our previous forecasts. We are seeing rapid progress with encouraging survival benefits in both our Phase 2 trials per recent announcements and publications, and look forward to sharing our upcoming update of clinical data at the American Association for Cancer Research Annual Meeting being held in San Diego April 24 to 29," commented Saiid Zarrabian, DelMar's President and Chief Executive Officer. "Following a productive quarter, we continue to believe that our cash position will provide the runway to enable us to achieve topline results for two of our three patient groups in our two Phase 2 trials."

RECENT CORPORATE UPDATES

January 2020 - Announced the publication of previously released interim clinical data in the February 2020 issue of peer-reviewed journal, Glioma.  The article highlights results from the first 22 patients of our ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme ("GBM") being conducted at Sun Yat-sen University Cancer Center ("SYSUCC") in China.
November 2019 – Provided positive interim clinical data and held Key Opinion Leader GBM summit at the Society for Neuro-Oncology annual meeting.  The updated clinical data in two poster sessions included the following:

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED DECEMBER 31, 2019

For the three months ended December 31, 2019, the Company reported a net loss of approximately $1.7 million, or $0.15 per share, compared to a net loss of approximately $1.8 million, or $0.75 per share, for the same period of 2018.

For the six months ended December 31, 2019, the Company reported a net loss of approximately $3.3 million, or $0.35 per share, compared to a net loss of approximately $3.8 million, or $1.63 per share, for the same period of 2018.

SAN DIEGO, Sept. 10, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the year ended June 30, 2019.

"This has been a productive quarter and year for DelMar as we have achieved multiple data milestones for both of our Phase 2 GBM trials for VAL-083," commented Saiid Zarrabian, DelMar's President and Chief Executive Officer. "Most importantly, based on recent budget refinements, we now believe we have sufficient capital to achieve release of topline data for two of our three currently enrolling MGMT-unmethylated GBM patient groups. These topline results include the recurrent setting GBM trial being conducted at the MD Anderson Cancer Center and the first line GBM trial being conducted at Sun Yat-sen University Cancer Center in China.  We anticipate results from both of these trials to be announced during the fourth quarter of calendar year 2020 and will be supported by the Company's recent financings completed in June and August 2019. Additionally, we have also relocated our headquarters to San Diego to position ourselves for better access to required expertise as we advance our trials."

RECENT CORPORATE UPDATES

• September 2019 - Moved corporate headquarters to San Diego, California
• August 2019 – Closed an underwritten public offering with net proceeds of approximately $6.7 million
• August 2019 – Provided update on Phase 2 clinical study on first line therapy in newly diagnosed MGMT-unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center.  At the time of the update, nine patients were assessed as having achieved complete response, seven were assessed with stable disease, and one was assessed with disease progression
• July 2019 – Enrolled first patient in adjuvant (pre-temozolomide maintenance) arm of Phase 2 open label study of VAL-083 being conducted at MD Anderson Cancer Center (MDACC)
• July 2019 – Provided enrollment update of Phase 2 open label study of VAL-083 in recurrent GBM patients with MGMT-unmethylated status.  As of this announcement, 56 of the planned 83 patients had been enrolled in the study being conducted at MDACC
• June 2019 – Closed on registered direct financing with net proceeds of approximately $3.2 million
• May 2019 – Expanded Scientific Advisory Board to include leading neuro-oncologists, Dr. David Reardon from Dana-Farber Cancer Center, Dr. Timothy Cloughsey from David Geffen School of Medicine, and Dr. Nicholas Butowski from UCSF and the Brain Tumor Center
• April 2019 – Announced formation of Scientific Advisory Board, which includes current members of the Company's board of directors, Dr. Napoleone Ferrara and Dr. John de Groot from the MD Anderson Cancer Center

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED JUNE 30, 2019

At June 30, 2019, the Company had cash and cash equivalents on hand of approximately $3.7 million.  In August 2019, the Company completed an underwritten public offering for net proceeds of approximately $6.7 million. The proceeds from the August 2019 financing combined with cash and cash equivalents on hand at June 30, 2019 are expected to be sufficient to fund the Company's planned operations into the fourth quarter of calendar year 2020.

For the year ended June 30, 2019, the Company reported a net loss of approximately $8.0 million, or $3.16 per share, compared to a net loss of approximately $11.1 million, or $5.42 per share, for the year ended June 30, 2018.

VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 14, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, today announced the pricing of an underwritten public offering of 6,750,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase up to an aggregate of 6,750,000 shares of common stock.  Each share of common stock (or pre-funded warrant) is being sold together with one warrant to purchase one share of common stock at a combined effective price to the public of $1.00 per share and accompanying warrant.  Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $6.8 million.

The warrants will be immediately exercisable at a price of $1.00 per share of common stock and will expire five years from the date of issuance.  The shares of common stock (or pre-funded warrants) and the accompanying warrants, can only be purchased together in the offering, but will be issued separately and will be immediately separable upon issuance.  The offering is expected to close on or about August 16, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as the book-running manager and Dawson James Securities, Inc. is acting as a co-manager in connection with the offering.

DelMar has granted the underwriters a 45-day option to purchase up to an additional 1,012,500 shares of common stock and/or warrants to purchase up to 1,012,500 shares of common stock, at the public offering price less discounts and commissions.

The Securities and Exchange Commission (the "SEC") declared effective a registration statement on Form S-1 (File No. 333-232931) relating to these securities on August 14, 2019.  A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.  The offering is being made only by means of a prospectus forming part of the effective registration statement.  Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.  Before investing in this offering, interested parties should read in their entirety the registration statement that the Company has filed with the SEC, which provides additional information about the Company and this offering.

VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 13, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, provided an update on the first 20 patients enrolled in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 in combination with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM. 

As of August 1, 2019, 17 of the first 20 enrolled patients have received at least their first assessment (two patients have not been enrolled long enough to receive their first assessment and one patient died before their first assessment). "Best Overall Response" for these patients per investigator assessment were:

• Nine have been assessed as having achieved a complete response (CR) (9/17, or 53%)
• Seven have been assessed with stable disease (SD), (7/17, or 41%)
• One has been assessed as disease progression (PD) (1/17, or 6%)

Importantly, 16 of the 20 patients enrolled (80%) were still alive as of the August 1, 2019data cut-off date.  The Company recently announced the enrollment of the 20th patient into this trial.

Dr. David Reardon, clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at the Harvard Medical School, and Dr. John de Groot, Professor and Chairman ad interim in the Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center (MDACC), are considered key opinion leaders in the brain cancer field and currently serve as DelMar Scientific Advisory Board members.  Dr. Reardon commented, "Both John and I agree that we desperately need something better to offer our patients and we feel that VAL-083 has some promise and potential." 

Dr. Reardon added, "For a tumor such as GBM, which is intrinsically infiltrative and destructive in the brain, stabilization of disease is an important achievement."

Professor Zhong-ping Chen, Founder Chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center (SYSUCC), who is the study's principal investigator, stated, "We are pleased to be leading this Phase 2 trial for first-line GBM treatment with DelMar, and are encouraged by the enhanced levels of tumor shrinkage and the complete responses we are observing after treatment with VAL-083 in combination with radiation. These preliminary data appear to support the premise that VAL-083 has the potential to provide a valuable treatment option for these patients. We look forward to completing full enrollment in the study as soon as possible."

This Phase 2 trial which is being conducted at SYSUCC in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.  Of the 20 patients enrolled, 17 (85%) have received their two-month (post-third cycle) MRI and investigator assessment, 13 (65%) have received their five-month MRI and investigator assessment, and seven (35%) have received their eight-month MRI and investigator assessment. Two patients (10%) have not been on the study long enough to reach their first assessment, and one patient (5%) died before their first assessment.  Assessments are based on the trial investigator's clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria.

Saiid Zarrabian, DelMar's president and chief executive officer, noted, "We continue to be encouraged by these early results and look forward to the completion of enrollment for our two, late-stage, Phase 2 studies. These results support our optimism that VAL-083 may provide a better treatment option than currently available treatments."

This Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene.  The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy.  Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

The Company also recently announced the initiation of an adjuvant arm to the MDACC study to provide early disease data on VAL-083.  This arm will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.  This arm is in addition to a trial arm treating patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled, and both arms are being conducted at MDACC.

VANCOUVER, British Columbia and MENLO PARK, Calif., July 31, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, today announces it has achieved two-thirds enrollment in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed MGMT-unmethylated GBM. The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

"While treating glioblastoma patients with an unmethylated MGMT promoter is particularly challenging, we have been encouraged by the enhanced levels of tumor shrinkage observed to date following treatment with VAL-083 in combination with radiation," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study's principal investigator. "Having reached this two-thirds enrollment point, we look forward to seeing further results corroborating the preliminary data we've received, which does appear to support the premise that VAL-083 may provide an additional and valuable treatment option for these difficult-to-treat patient conditions."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care temozolomide (TMZ) plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population. 

"This first line study continues to enroll at a consistent pace, and we look forward to completing enrollment in this very important patient population. Once complete, we believe that the data from this study may provide additional support for the advancement of the adjuvant setting trial at MD Anderson Cancer Center, as well as to potentially support a future US study for utilization of VAL-083 as a first-line therapy for newly-diagnosed patients with an unmethylated MGMT gene promoter," commented Saiid Zarrabian, DelMar's Chief Executive Officer. "In the meantime, we are very proud to be advancing all three of our Phase 2 programs for VAL-083, including the two-arm trial being conducted at MD Anderson Cancer Center in Texas for patients with recurrent GBM and those who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. We look forward to continuing to provide updates on the progress of all three patient populations."

The company recently announced the initiation of an adjuvant arm to the MD Anderson study to provide early disease data on VAL-083.  This arm will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. This arm is in addition to a trial arm treating patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled, and both arms are being conducted at the University of Texas MD Anderson Cancer Center.

VANCOUVER, British Columbia and MENLO PARK, Calif., July 24, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, today announces that the first patient has been treated in the adjuvant (pre-temozolomide maintenance) trial arm of VAL-083's Phase 2 study in MGMT-unmethylated glioblastoma multiforme (GBM) being conducted at the University of Texas MD Anderson Cancer Center (MDACC).  This recently-approved arm of the study will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with temozolomide (TMZ) but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.

"Treating patients with MGMT promoter unmethylated glioblastoma is particularly challenging," commented principal investigator Dr. Barbara O'Brien, assistant professor of Neuro-Oncology at the MD Anderson Cancer Center.  "These tumors are inherently resistant to temozolomide, leaving physicians and patients without viable alternative treatments, so I'm particularly pleased that we have added this additional trial arm to our ongoing study.  Better therapies are greatly needed for both newly-diagnosed and recurrent glioblastoma, and VAL-083 has so far shown a favorable safety profile and provided early, but encouraging, results from the trial that is currently underway."

This adjuvant arm, which was recently approved by the MDACC Institutional Review Board, will provide early disease data on VAL-083, in contrast to those patients enrolling in the Company's original recurrent trial arm of the MDACC clinical study who have typically been heavily pre-treated with TMZ prior to disease recurrence.  In the recurrent setting, the Company previously announced that MDACC had approved up to 35 additional patients to this recurrent GBM study at a dose of 30 mg/m2, allowing for a total of up to 83 patients to be enrolled.  To date, 56 recurrent patients have been enrolled.  DelMar is actively enrolling patients for both trial arms of the clinical study at MDACC.

Concurrently, the Company is conducting a Phase 2 clinical study of VAL-083 as first line treatment for GBM in combination with radiotherapy in China at the renowned Sun Yat-sen University Cancer Center for which it provided an update on June 3, 2019.  This update can be accessed via the company's website at https://www.delmarpharma.com/news-media/press-releases/detail/900/delmar-provides-clinical-update-on-val-083-from-ongoing.  VAL-083 has been granted orphan drug designations by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.  It has also been granted fast-track status for the treatment of recurrent GBM by the U.S. FDA.

"Enrolling and treating the first adjuvant patient in this study is an important milestone as it provides us with the opportunity to understand the best use for VAL-083 in the clinical setting – whether as first-line therapy along with radiation, as adjuvant therapy immediately following chemoradiation or in the recurrent setting.  We firmly believe in the potential for this compound and look forward to providing an opportunity for a larger patient population to benefit from VAL-083 treatment. We look forward to providing updates on the progress of all of our clinical programs," commented Saiid Zarrabian, DelMar's Chief Executive Officer.

VANCOUVER, British Columbia and MENLO PARK, Calif., June 3, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it entered into securities purchase agreements with certain institutional investors in connection with a registered direct offering of an aggregate of 1,170,000 shares of common stock and, in a concurrent private placement, warrants to purchase 760,500 shares of common stock. The combined purchase price for one share of common stock and each warrant will be $3.10, for aggregate gross proceeds of $3.6 million. The warrants have an exercise price of $3.10 per share, are immediately exercisable and have a term of exercise of five years. The offering and concurrent private placement are expected to close on or about June 5, 2019, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the lead placement agent and Dawson James Securities, Inc. is acting as co-placement agent in connection with the offering and concurrent private placement.

DelMar currently intends to use the net proceeds of the offering and concurrent private placement for its clinical trials and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. In addition, DelMar may use the net proceeds for investments in businesses, products or technologies that are complementary to its business.

VANCOUVER, British Columbia and MENLO PARK, Calif., May 29, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today provided an update to stockholders regarding the Company's rights offering and the key dates relative to the offering.   Stockholders or interested parties are advised to direct all questions and informational requests to the contacts listed below.

All record holders of rights that wish to participate in the rights offering must deliver a properly completed and signed subscription rights statement, together with payment of the subscription price for both basic subscription rights and any over subscription privilege election for delivery no later than 5:00 PM Eastern Time on June 12, 2019 to the Subscription Agent:

 

Under the rights offering, DelMar distributed one non-transferable subscription right for each share of common stock and each participating warrant (on an as-if-converted-to-common-stock basis) held on the record date. The subscription rights are exercisable for up to an aggregate of $8.0 million of units with aggregate participation to be allocated among holders on a pro rata basis if in excess of that threshold. 

Each right entitles the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series C Convertible Preferred Stock with a stated value of $1,000 (and immediately convertible into shares of DelMar's common stock at a conversion price of $4.00 per share) and 125 warrants to purchase DelMar's common stock with an exercise price of $4.40 per share. The warrants will be exercisable for 5 years after the date of issuance. 

Holders who fully exercise their basic subscription rights will be entitled, if available, to subscribe for an additional amount of units that are not purchased by other holders, on a pro rata basis and subject to the $8.0 million aggregate offering threshold and other ownership limitations.  The subscription rights are non-transferrable and may only be exercised during the anticipated subscription period which opened on Wednesday, May 29, 2019 and now expires at 5:00 PM ET on June 12, 2019, unless extended; provided that in no event shall such extensions extend beyond July 31, 2019.

VANCOUVER, British Columbia and MENLO PARK, Calif., May 15, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the third quarter ended March 31, 2019. DelMar executive management will host a business update conference call for investors, analysts and other interested parties on May 23, 2019 at 4:30 p.m. Eastern Time.

"The third quarter proved to be an important period of progress as we advanced VAL-083 in both of our Phase 2 clinical trials in GBM with encouraging early results, especially in our first line GBM trial, while continuing the evaluation of this first-in-class, small molecule's potential to treat a range of solid tumor cancers. I am also pleased by the establishment of our formal Scientific Advisory Board led by world-renowned oncology experts," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "In addition, we initiated execution of our planned rights offering to provide capital to continue the advancement of our clinical trials through their estimated planned completion in mid-calendar 2020, and we executed the necessary recent reverse stock split which potentially enables us to regain compliance with Nasdaq's listing requirements."

Key Highlights and Recent Developments

• Achieved the halfway enrollment point for VAL-083's Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated glioblastoma multiforme (GBM) study at Sun Yat-sen University Cancer Center (SYSUCC) with encouraging results for 11 of the initial 15 patients treated
• Continued enrolling patients in VAL-083's Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent GBM study being conducted at the MD Anderson Cancer Center (MDACC)
• Received approval from MDACC's Institutional Review Board (IRB) for protocol expansion to include maintenance stage, MGMT-unmethylated GBM patients. This provides an opportunity for enrollment of a larger patient population who may benefit from VAL-083 in an earlier stage of this hard-to-treat disease
• Presented data supporting VAL-083 as potential treatment for pediatric brain tumors at the Society for Neuro-Oncology Pediatric Neuro-Oncology Basic and Translational Research Conference
• Established Scientific Advisory Board with inaugural members Drs. Napoleone Ferrara and John de Groot
• Potentially regained compliance with Nasdaq's minimum bid price listing requirement of $1.00 by executing a 1-for-10 reverse stock split
• Launched a financing via a shareholder rights offering

On February 20, 2019, DelMar announced that its Phase 2 study evaluating VAL-083 in patients with newly diagnosed GBM achieved its halfway enrollment point. This trial, targeted to enroll up to thirty patients, is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene.  An estimated 60% of GBM patients possess an unmethylated MGMT gene, which confers a more limited response to current standard of care treatment as well as a lower survival probability. This clinical trial was initiated in February 2017 and is being conducted at SYSUCC in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. As of February 15, 2019, fifteen patients have been enrolled in this study.

The Company was pleased to report that for the 15 patients enrolled as of February 15, 2019, 11 completed their prospectively planned Magnetic Resonance Imaging (MRI) scans and have had their initial assessment for tumor progression. Tumor progression is based on the trial investigator's clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. Of these 11 patients, five were assessed by the Principal Investigator as having a "Complete Response," three of whom were based on significant tumor shrinkage, and two of whom were based on their tumors continuing to remain "below measurable level" from post-surgery baseline MRI to post-cycle three MRI. Additionally, six patients were assessed as having "Stable Disease." Of the remaining four patients, one died prior to their post-cycle three MRI and three have not been on study long enough to reach their planned post-cycle three MRI.  As of the February 15, 2019 data cutoff, 12 of the 15 enrolled patients were still alive. Similar to prior experience, myelosuppression has been the most common adverse event observed. Two dose-limiting toxicities have been reported (thrombocytopenia) - one at the 40 mg/m2/day dose and one at the 30 mg/m2/day dose.

Throughout the quarter, DelMar continued to enroll patients in VAL-083's Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent GBM study being conducted at the MDACC. On April 3, 2019, the Company announced that the MDACC's IRB approved a trial protocol amendment to expand the study with the addition of up to 35 patients at a dose of 30 mg/m2. Also, the MDACC IRB approved the addition of up to 24 patients in the pre-temozolomide (TMZ) maintenance setting.  The biomarker driven trial, which was originally designed as a single arm study evaluating VAL-083 in patients with MGMT-unmethylated bevacizumab (Avastin)-naïve recurrent GBM, has been expanded to include an additional maintenance-stage (adjuvant therapy) treatment group. This protocol amendment, in addition to the Company's ongoing Phase 2 trial in newly diagnosed patients with MGMT-unmethylated GBM being conducted at SYSUCC, expands DelMar's evaluation range of VAL-083 as a potential treatment for unmethylated GBM patients to include newly-diagnosed, maintenance-stage, and recurrent patients. Maintenance-stage GBM provides the greatest opportunity to control disease progression after radiation therapy, and represents the largest addressable GBM market opportunity for VAL-083 given patients are typically healthier and as such, are able to optimally benefit therapeutically from increased treatment cycles compared to the recurrent treatment setting. Maintenance GBM patients may be able to receive 12+ cycles of VAL-083 versus five or six cycles for recurrent GBM patients.

At the American Association for Cancer Research's annual meeting in April 2019, we reported that per investigator assessment at the end of cycle two for the MDACC study:

• 9/35 (25.7%) patients initially receiving 40 mg/m2 exhibited Stable Disease
• 4/10 (40.0%) patients initially receiving 30 mg/m2 exhibited Stable Disease
• Two patients have not yet reached the end of cycle 2

The Company has launched a rights offering made available to stockholders of record as of Tuesday, May 21, 2019. If fully subscribed, this financing initiative will provide DelMar with sufficient cash to fund planned operations into the middle of calendar 2020, and the estimated enrollment completion date for all three of our Phase 2 trials.

VANCOUVER, British Columbia and MENLO PARK, Calif., May 7, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that it will effect a 1-for-10 reverse stock split of its outstanding common stock. This will be effective for trading purposes as of the commencement of trading on Wednesday, May 8, 2019.

The reverse stock split was previously approved by the Board of Directors of DelMar in accordance with Nevada law, under which no stockholder approval is required, and is intended to increase the per share trading price of DelMar's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Global Market (Rule 5550(a)(2)). DelMar's common stock will continue to trade on the NASDAQ Capital Market under the symbol "DMPI" and under a new CUSIP number, 247078306. As a result of the reverse stock split, every ten pre-split shares of common stock outstanding will become one share of common stock. The reverse stock split will also proportionately reduce the number of shares of authorized common stock from 70 million to 7 million shares.  The reverse split will also apply to common stock issuable upon the exercise of DelMar's outstanding warrants and stock options.

DelMar's transfer agent, Mountain Share Transfer, LLC, which is also acting as the exchange agent for the reverse split, will provide instructions to shareholders regarding the process for exchanging share certificates. Any fractional shares of common stock resulting from the reverse stock split will be rounded up to the nearest whole post-split share and no shareholders will receive cash in lieu of fractional shares.

VANCOUVER, British Columbia and MENLO PARK, Calif., May 8, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc.(Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today provided an update to stockholders regarding the Company's rights offering and the key dates and terms relative to the offering.  Stockholders are advised to ensure they complete their open market purchases of DelMar's common stock by Friday, May 17, 2019 to be considered a stockholder of record on Tuesday, May 21, 2019.  Stockholders or interested parties are advised to direct all questions and informational requests to the contacts listed below.

Under the proposed rights offering, DelMar will distribute to its holders of common stock and to holders of certain warrants as of May 21, 2019, at no charge, one non-transferable subscription right for each share of common stock held or deemed held on the record date.  Each right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series C Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into common stock at an assumed conversion price of $4.00) and 125 warrants with an assumed exercise price of $4.40.  The warrants will be exercisable for five (5) years after the date of issuance and shall be redeemable as described in the preliminary and final prospectus, when available.

Subscription rights are non-transferable and may only be exercised during the anticipated subscription period of Wednesday May 22, 2019 through 5:00 PM ET on Wednesday June 5, 2019, unless extended by DelMar; provided that in no event shall such extensions extend beyond July 20, 2019.

The expected calendar for the rights offering, unless extended or modified in DelMar's sole discretion, is as follows:

• Friday, May 17, 2019: Ownership Day — in order to be considered a stockholder of record on Tuesday, May 21, 2019, shares should be acquired by this date.
• Tuesday, May 21, 2019: Record Date
• Wednesday, May 22, 2019: Distribution Date; Subscription Period Begins
• Wednesday, June 5, 2019: Subscription Period Ends 5:00 PM ET.

Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other shareholders, on a pro rata basis and subject to ownership limitations.

DelMar has engaged Maxim Group LLC and Dawson James Securities Inc. as co-dealer-managers in the rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, may be directed to Maxim Group LLC at 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, or via email at syndicate@maximgrp.com or telephone at (212) 895-3745.

VANCOUVER, British Columbia and MENLO PARK, Calif., Feb. 20, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that its Phase 2 study testing VAL-083 in patients with newly diagnosed glioblastoma multiforme (GBM) has achieved its halfway enrollment point. This trial, targeted to enroll up to thirty patients, is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene.  An estimated 60% of GBM patients possess an unmethylated MGMT gene, which confers a more limited response to current standard of care treatment as well as a lower survival probability. This clinical trial was initiated in February 2017 and is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company.

The Company is pleased to report that for the 15 patients enrolled to date, 11 have completed their prospectively planned Magnetic Resonance Imaging (MRI) scans and have had their initial assessment for tumor progression. Tumor progression is based on the trial investigator's clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. Of these 11 patients, five were assessed by the Principal Investigator as having a "Complete Response", three of whom were based on significant tumor shrinkage, and two of whom were based on their tumors continuing to remain "below measurable level" from post-surgery baseline MRI to post-cycle 3 MRI. Additionally, six patients were assessed as having "Stable Disease." Of the remaining four patients, one died prior to their post-cycle 3 MRI and three have not been on study long enough to reach their planned post-cycle 3 MRI.  As of the February 14, 2019 data cutoff, 12 of the 15 enrolled patients are still alive. Similar to prior experience, myelosuppression has been the most common adverse event observed. Two dose-limiting toxicities have been reported (thrombocytopenia) - one at the 40 mg/m2/day dose and one at the 30 mg/m2/day dose.

"GBM is a cancer with a very high unmet medical need, especially for patients with an MGMT-unmethylated biomarker who are provided with limited existing treatment options," stated Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "We are encouraged that we have completed the dose escalation stage of this study and that 30 mg/m2/day of VAL-083 in combination with radiation therapy was generally safe and well-tolerated in this trial. And while these results are preliminary, we are also enthusiastic that five of the first twelve patients available for efficacy measurements have initially been assessed as having a Complete Response. With the clinical trial rapidly enrolling into its expansion phase, we look forward to providing a final data update once the study is completed."

The Company will be providing further details and an update on this trial at the annual meeting of the American Association for Cancer Research being held March 29 to April 3, 2019.

Professor Zhong-ping Chen, Founder Chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study's Principal Investigator, stated that "treating glioblastoma patients with an unmethylated MGMT promoter is particularly challenging. While the clinical trial is still early, and we are only at the halfway point in enrollment, we are highly encouraged at the enhanced levels of tumor shrinkage and the complete responses we are observing after treatment with VAL-083 in combination with radiation. This preliminary data appears to support the premise that VAL-083 has the potential to provide a valuable treatment option for these patients."

The clinical trial in newly diagnosed GBM is designed to enroll up to 30 patients to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care temozolomide (TMZ) plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

The clinical trial consists of two parts:

Part 1 is a dose-escalation and induction format to confirm the recommended dose of VAL-083 when administered concurrently with radiation therapy based on safety and tolerability. The patients received VAL-083 at 20 mg/m2/day, 30 mg/m2/day or 40 mg/m2/day along with standard radiation treatment. The dose escalation phase of the study was concluded in October 2018.
Part 2 comprises an expansion phase whereby VAL-083 will be studied in up to 20 additional patients. Based on the best balance of efficacy and tolerability, the dose of VAL-083 chosen for the expansion phase of the study was 30 mg/m2/day. This phase of the study is ongoing and is continuing to enroll patients.
This phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT03050736) is expected to provide the scientific basis for larger studies to support submission of marketing applications. Ideally, data from these larger studies will result in approval of VAL-083 as first line therapy for all newly-diagnosed patients with an unmethylated MGMT gene promoter.

VANCOUVER, British Columbia and MENLO PARK, Calif., Feb. 12, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the second quarter ended December 31, 2018. DelMar executive management will host a business update conference call for investors, analysts and other interested parties on February 19, 2019 at 4:30 p.m. Eastern Time.

"During the second quarter, we continued enrollment in our Phase 2 clinical trials for MGMT-unmethylated GBM patients at the MD Anderson Cancer Center in Houston, Texas, and at Sun Yat-sen University Cancer Center in Guangzhou, China," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "We are now nearing full enrollment at MD Anderson and halfway enrollment in China. We are eagerly anticipating data from each of these studies."

RECENT HIGHLIGHTS

Continued enrolling patients in Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme ("GBM") study being conducted at the MD Anderson Cancer Center (the "MDACC study").
Continued enrolling patients in Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen University Cancer Center.
On February 4, 2019, the Company received a written notice that The Nasdaq Capital Market LLC (Nasdaq) had granted the Company an extension until June 25, 2019 to regain compliance with the Minimum Bid Price requirement. During the extension, the Company must remain in compliance with all other listing requirements of Nasdaq.
Based on overall clinical and corporate development progress achieved to date, DelMar expects to have cash available to fund planned operations into the middle of calendar 2019.

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 20, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, presented scientific updates, including data from two ongoing clinical trials, at the 23rd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) held on November 15-18, 2018 in New Orleans, LA.

"In our much-awaited Phase 2 study of VAL-083 in patients with MGMT-unmethylated, Bevacizumab-Naïve Recurrent Glioblastoma Multiforme (rGBM), we are pleased with the accelerated enrollment of this study with the vast majority of subjects already enrolled. What has become amply clear is that in ‎this aggressive tumor type, which can double in size every 6-8 weeks, VAL-083 when used for two or more cycles can stabilize the tumor and slow down its incessant growth," commented Saiid Zarrabian, President and Chief Executive Officer. 

"At this time, some subjects are still on drug and others are being followed for survival and we wait to see if this observed stabilization of the tumor favorably impacts median overall survival. The preclinical and clinical efficacy of VAL-083 in MGMT-unmethylated GBM population, along with the 2017 revised NCCN guidelines for MGMT-unmethylated patients which cautions against the use of temozolomide for MGMT-unmethylated GBM patients, creates a therapeutic opportunity not only for newly diagnosed patients, but also in the follow-on maintenance setting currently using temozolomide, all of which signals a path forward for VAL-083," added Mr. Zarrabian.

At the SNO 2018 conference, DelMar provided an update on the company's ongoing Phase 2 clinical study in a poster entitled "Phase 2 Study of Dianhydrogalactitol (VAL-083) in Patients with MGMT-unmethylated, Bevacizumab-Naïve Recurrent Glioblastoma." This study is being conducted in collaboration with The University of Texas MD Anderson Cancer Center (MDACC). This biomarker-driven trial (testing for MGMT methylation status) is designed to enroll up to 48 patients to determine if VAL-083 treatment improves overall survival compared to historical reference control of 7.15 months with lomustine.

As of October 31, 2018, 44 (of 48) patients have been enrolled
41 of those enrolled have received at least 1 cycle of VAL-083
7 patients are currently receiving treatment; 22 being followed for survival; 19 deceased thus far
Study subjects received a median of 2 cycles of therapy
Of the 27 subjects that completed at least 2 cycles of treatment, 9/27 (33.33%) subjects exhibited stable disease (SD) at the end of cycle 2
The most prevalent side effect with the 40 mg/m2/day dose of VAL-083 was myelosuppression (thrombocytopenia and neutropenia)
Myelosuppression was also correlated with prolonged (> 5 cycles) prior front-line temozolomide use
The Company also provided an update on its Phase 1/2 clinical study in a poster entitled "Phase I/II Study of Dianhydrogalactitol (VAL-083) with Radiation Therapy with Newly Diagnosed MGMT-unmethylated Glioblastoma." This trial is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. The trial is designed to enroll up to 30 patients to determine if first-line therapy with VAL-083 treatment, in lieu of first-line temozolomide, improves progression free survival (PFS).

As per the 2017 National Comprehensive Cancer Network (NCCN) guidelines, this trial sets out with the vision of eradicating the unnecessary use of temozolomide in the approximately 60% of GBM patients, as noted in prior studies, with unmethylated MGMT gene promoter
The Company reported that 10 patients have been enrolled as of October 31, 2018
These 10 patients were part of the "3+3" dose escalation cohorts, and were treated with VAL-083 at each different dose on days 1 to 3 of a 21-day cycle along with radiation at 2Gy/day x 5 days for 6 weeks. The same dosing regimen of VAL-083 would be applied during the maintenance stage following six-week chemo-radiation
In the dose-escalation stage, grade 3+ myelosuppression was observed in 2 of 3 patients treated with VAL-083 at 40 mg/m2/day
The lower VAL-083 dose of 30 mg/m2/day was hence moved forward into the expansion phase of the trial
A 20-patient expansion cohort has now commenced enrolling
The primary endpoint of this trial is progression free survival and secondary endpoints include tumor response, overall survival and pharmacokinetics
In addition, DelMar presented three preclinical updates during the conference:

VAL-083 Inhibits Proliferation of a Panel of Eight Glioblastoma Stems Cell Lines: Downregulation of BDR4 as a Novel Anti-Neoplastic Mechanism

In this poster, the authors discuss their preclinical finding that when glioblastoma stem cell lines are treated with VAL-083 there is a downregulation of the transcription activator bromodomain-containing protein 4 (BRD4).

Chromatin remodeling through histone acetylation is a key step in the regulation of the gene expression in both normal and tumor cells. Members of the bromodomain family of proteins, such as BRD4, interact with acetylated histones to assemble chromatin complexes and transcription activators at specific gene promoter sites, including tumor oncogenes. Selective downregulation of bromodomain proteins such as BRD4 by agents such as VAL-083 can therefore inhibit the interaction of BDR4 with acetylated histones at promoter sites, resulting in a reduction of downstream signaling events.  Thus, it is possible that VAL-083 may elicit its DNA-damaging action, at least in part, by interrupting chromatin remodeling in cancer cells.

Dianhydrogalactitol (VAL-083) has the Potential to Overcome Major Challenges in the Treatment of Diffuse Intrinsic Pontine Glioma (DIPG)

In this poster, the authors discuss the potential for VAL-083 either as a single-agent, or as part of combination therapy regimens, for the treatment of diffuse intrinsic pontine glioma (DIPG). DIPG is a difficult-to treat, inoperable, rare pediatric brain tumor with very poor prognosis and a dismal survival outlook.  In this poster the authors report that VAL-083 is active as a single-agent and synergistic with AZD1775, a Wee1 inhibitor, against DIPG cell lines with varying genetic profile.

Dianhydrogalactitol (VAL-083) Reduces Glioblastoma Tumor Growth In Vivo Upon Bevacizumab-induced Hypoxia

Treatment of GBM with second-line bevacizumab after progression on first-line temozolomide is the standard-of-care for this disease. However, bevacizumab has not only failed to show an improved benefit in these patients, but has also been found to induce intratumor hypoxia, which is then implicated in increased chemoresistance. Preclinically, it has been previously demonstrated that bevacizumab hypoxia upregulates GLUT-1/GLUT-3 glucose transporters. In such a milieu, VAL-083, due to its simple structure, has a unique advantage of enhanced intra-tumoral transport and uptake. The authors seek confirmation of this in-vitro observation in a GBM xenograft model. The data shows that in such mouse models the GBM tumor shrinkage is best when bevacizumab and VAL-083 are administered together compared to when either agent is used as monotherapy.

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 14, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the first quarter ended September 30, 2018. DelMar executive management will host a business update conference call for investors, analysts and other interested parties on November 20, 2018 at 4:30 p.m. Eastern Time.

"During the quarter, we continued to focus on advancing our Phase 2 clinical trials for MGMT-unmethylated GBM patients at the MD Anderson Cancer Center in Houston, Texas, and at Sun Yat-sen University Cancer Center in Guangzhou, China where we have seen accelerated enrollment in both studies," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar Pharmaceuticals. "Furthermore, we launched an initiative with Oppenheimer & Co. Inc. to explore and evaluate strategic opportunities to facilitate shareholder value generation."

RECENT HIGHLIGHTS

Continued enrolling patients in Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme ("GBM") study being conducted at the MD Anderson Cancer Center (the "MDACC study").
Continued enrolling patients in Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen University Cancer Center.
At the annual meeting of the Society for Neuro-Oncology being held from November 15 to 18, 2018, the Company will provide clinical trial updates on both of its Phase 2 studies in MGMT-unmethylated GBM patients.  In addition, updated preclinical data on VAL-083 in combination with Avastin, and VAL-083 as a potential treatment of pediatric diffuse intrinsic pontine glioma ("DIPG") will be presented.
Based on overall clinical and corporate development progress achieved to date, we expect to have cash available to fund planned operations into the middle of calendar 2019

VANCOUVER, British Columbia and MENLO PARK, Calif., Oct. 10, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the publication of a peer-reviewed scientific paper on the mechanism of action for VAL-083, the Company's product candidate, in Cell Death and Disease by Nature Publishing Group.

The paper, entitled "Dianhydrogalactitol induces replication-dependent DNA damage in tumor cells preferentially resolved by homologous recombination," details the mechanism of action for VAL-083 (dianhydrogalactitol) involving S-phase dependent DNA double stand breaks (DSB) and homologous recombination (HR) DNA repair.  This peer-reviewed publication further validates VAL-083's unique anti-tumor mechanism and differentiates it from the standard-of-care. In addition, this research supports the use of VAL-083 in combination with drugs targeting cancer cells in S-phase, including topoisomerase inhibitors.  Furthermore, the results suggest VAL-083 as a potential treatment option for tumors with impaired HR DNA repair, such as high-grade ovarian carcinomas, or tumors treated with PARP inhibitors.

The research was conducted in the laboratory of Dr. Mads Daugaard at the Vancouver Prostate Center, one of the world's most respected cancer research institutes. Using non-small cell lung cancer (NSCLC) as a model system for cancer cells, the research group showed that VAL-083-induced cytotoxicity materialized when the cells entered the S-phase of the cell cycle. The resulting DNA damage subsequently triggered irreversible cell cycle arrest and ultimately cancer cell death. Further analysis revealed that cancer cells attempted to use their HR DNA repair pathway to reverse VAL-083-induced DNA damage and cancer cells with an impaired HR repair pathway were therefore particularly sensitive to VAL-083.

DelMar is currently studying VAL-083 in two collaborator-supported, biomarker driven, Phase 2 clinical trials for MGMT-unmethylated glioblastoma multiforme (GBM). As demonstrated in prior publications, the DNA repair protein MGMT is overexpressed in over 60% of GBM patients which causes resistance to the standard-of-care (temozolomide). In contrast to temozolomide, which targets the O6-position of guanine vulnerable to MGMT repair, VAL-083 targets the N7-position of guanine. This distinct mechanism-of-action differentiates VAL-083 from temozolomide and nitrosoureas, allowing VAL-083 to overcome MGMT-related chemoresistance, thereby addressing a significant unmet medical need.

VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 24, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the year ended June 30, 2018. DelMar executive management will host a business update conference call for investors, analysts and other interested parties on September 25, 2018 at 4:30 p.m. Eastern Time.

"This past fiscal year has been an instrumental period for the Company on both corporate and clinical development fronts," commented Saiid Zarrabian, President and Chief Executive Officer. "Moving forward, we are now a streamlined organization well positioned to advance VAL-083's two Phase 2, biomarker-driven, clinical trials for MGMT-unmethylated GBM while evaluating combination therapies for this novel, first-in-class, DNA-targeting, small molecule, and in concert, ramping-up efforts to explore strategic opportunities to enhance shareholder value."

RECENT HIGHLIGHTS

Continued enrolling patients in Phase 2, open-label, second-line, Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme (GBM) study being conducted at the MD Anderson Cancer Center (the "MDACC study").
Continued enrolling patients in Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen University Cancer Center.
Engaged Oppenheimer & Co. Inc. as advisor to help manage the exploration and evaluation of a wide range of strategic opportunities
Strengthened Board of Directors and corporate governance by appointing world-renowned molecular biologist Dr. Napoleone Ferrara and Robert E. Hoffman as independent chairman
Appointed Saiid Zarrabian as full-time President and Chief Executive Officer
Based on overall clinical and corporate development progress achieved to date, expect to have cash available to fund planned operations into the middle of calendar 2019

VANCOUVER, British Columbia and MENLO PARK, Calif., June 26, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, today updated patient enrollment data for its Phase 2 open-label clinical trial of VAL-083 in bevacizumab (Avastin®)-naïve  recurrent glioblastoma multiforme (rGBM) patients with MGMT-unmethylated status.

This trial is being conducted at MD Anderson Cancer Center and as of June 15, 2018, has enrolled 33 of the planned 48 patients. The trial is designed to determine the impact of VAL-083 treatment on overall survival compared to historical reference control.

"We are pleased with the accelerated patient enrollment of our ongoing VAL-083 Phase 2 trial at MD Anderson Cancer Center. Presently, the trial is approximately six months ahead of schedule and based on the trial's protocol design, we anticipate the primary endpoint of median overall survival to be reached approximately three months after the final patient is enrolled," said Saiid Zarrabian, President and Chief Executive Officer of DelMar.

VANCOUVER, British Columbia and MENLO PARK, Calif., May, 17, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the third quarter ended March 31, 2018. DelMar executive management will host a business update conference call for investors, analysts and other interested parties on May 30, 2018 at 4:30 p.m. Eastern Time.

"This quarter has been a pivotal and important period for DelMar. I am pleased with our enhanced focus on leveraging VAL-083's unique mechanism of action to advance both of our Phase 2 clinical programs including MGMT-unmethylated, second-line, bevacizumab (Avastin) naïve glioblastoma, and MGMT-unmethylated, first-line, temozolomide-naïve glioblastoma. MGMT methylation status has become increasingly important in the diagnosis and treatment of glioblastoma, and a routine part of clinical practice as it is a well-established biomarker that correlates with resistance to the standard-of-care chemotherapy, temozolomide, and with patient outcomes. We believe that using this biomarker will optimize patient selection for treatment in future trials with our lead drug candidate, VAL-083, thereby streamlining development and enhancing opportunities for success in our clinical development programs," commented Saiid Zarrabian, Interim President and Chief Executive Officer.

KEY HIGHLIGHTS

Continued enrolling patients in the Company's Phase 2, open-label, second-line Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme (GBM) trial being conducted at the MD Anderson Cancer Center
Increased patient enrollment rate of the Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM trial at Sun Yat-sen University Cancer Center
Presented a positive interim update from ongoing open-label Phase 2 clinical trials in MGMT-unmethylated GBM at the Annual Meeting of the American Association for Cancer Research (AACR) held in April, 2018
Presented promising preclinical results supporting the potential of VAL-083 in the treatment of cancer patients whose tumors exhibit features that make them resistant to, or unlikely to respond to, currently available therapies at the Annual Meeting of AACR held in April, 2018
Presented promising preclinical data supporting the potential of VAL-083 as part of second- line combination treatment with Avastin for GBM at the biennial Canadian Neuro-Oncology meeting in May 2018
Ramped-up evaluation of improved development strategies for VAL-083's ovarian program, including specific biomarkers for optimal VAL-083 efficacy and combination treatment with PARP inhibitors, utilizing our newly formed clinical advisory board
Based on overall clinical and corporate development progress achieved to date, we expect to have cash available to fund planned operations into the third quarter of calendar 2019

VANCOUVER, British Columbia and MENLO PARK, Calif., April 17, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that the Company presented a positive update on its two ongoing clinical trials of VAL-083, a first-in-class small molecule chemotherapeutic, for the treatment of MGMT-unmethylated Glioblastoma Multiforme ("GBM") at the American Association for Cancer Research ("AACR") Annual Meeting.

"We are pleased with the continued progress of our ongoing clinical trials with VAL-083 as a potential treatment for MGMT-unmethylated GBM," said Saiid Zarrabian, interim president and chief executive officer.  "These trials are important elements of our clinical development strategy to advance VAL-083 as a potential treatment for GBM patients who have little or no viable alternatives."

DelMar presented the following updates in two poster presentations at the AACR Annual Meeting.

1.    A biomarker-driven, Phase 2 clinical trial of VAL-083 in patients with MGMT-unmethylated bevacizumab (Avastin)-naïve recurrent glioblastoma, currently being conducted in collaboration with the University of Texas MD Anderson Cancer Center.

Up to 48 patients with MGMT-unmethylated, bevacizumab-naïve, recurrent GBM, will be enrolled to determine if treatment with VAL-083 improves overall survival compared to historical reference control.

22 of a planned 48 patients have been enrolled as of March 31, 2018, compared to 15 patients enrolled as of October 31, 2017.
7 of the 22 enrolled patients (32%) have exhibited stable disease as best response.
Similar to prior clinical experience, myelosuppression has been the most common adverse event observed.
2.    A Phase 1-2 clinical trial of VAL-083 in combination with radiotherapy in patients with newly diagnosed MGMT-unmethylated GBM, currently being conducted in collaboration with Sun Yat-sen University Cancer Center.

Up to 30 patients with newly diagnosed MGMT-unmethylated GBM will be treated with VAL-083 combined with radiotherapy by 24 weeks of VAL-083 maintenance therapy.  The study is being conducted in two parts: (1) Dose-confirmation:  VAL-083 in cohorts (20, 30 and 40 mg/m2/day IV) to assess safety and activity when administered concurrently with x-ray telescope ("XRT") to confirm the maximum tolerated dose ("MTD"), and (2) Expansion: VAL-083 will be studied in up to 20 additional patients at the target dose of 40mg/m2 VAL-083 administered concurrently with XRT.

Dose-confirmation studying 20 and 30 mg/m2/day cycles has been completed (4 patients enrolled).
No dose-limiting toxicities have been reported following treatment with multiple cycles of VAL-083.
The next patient enrolled will receive the study target dose of 40 mg/m2/day VAL-083 combined with radiation.

VANCOUVER, British Columbia and MENLO PARK, Calif., Feb. 14, 2018 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the second quarter ended December 31, 2017. DelMar executive management will host a business update conference call for investors, analysts and other interested parties on Tuesday, February 20, 2018 at 4:30 p.m. Eastern Standard Time.

"This quarter has been an exciting period for DelMar. Our priority is to leverage VAL-083's unique mechanism of action to efficiently advance it into the most promising indications, including MGMT-unmethylated glioblastoma and platinum-resistant ovarian cancer.  We now have a revised VAL-083 development strategy that is focused on MGMT methylation status in glioblastoma, which has become routine in clinical practice as a biomarker which correlates with resistance to the standard-of-care chemotherapy with temozolomide (Temodar® "TMZ"), and patient outcomes. We believe using this biomarker will allow us to optimize patient selection for treatment with our lead drug candidate, VAL-083, thereby streamlining development and enhancing opportunities for success in our clinical development programs," commented Saiid Zarrabian, Interim President and Chief Executive Officer.

KEY DEVELOPMENTS AND UPDATED STRATEGIC PLAN

Evaluation of MGMT promoter methylation status has increasingly become common practice in the diagnostic assessment of glioblastoma multiforme (GBM).  DelMar believes that this provides it with an enhanced ability to leverage MGMT methylation as a biomarker to optimize patient selection for DelMar's novel DNA-targeting agent in the treatment of GBM.
The National Comprehensive Cancer Network (NCCN), provided updated guidelines for the standard treatment of GBM based on MGMT methylation status. DelMar believes these recently published guidelines may allow the Company to capitalize on VAL-083's unique mechanism of action and activity in the estimated 60 percent of GBM patients whose tumors are MGMT-unmethylated.
The U.S. Food and Drug Administration (FDA) allowed a second Investigational New Drug Application (IND) to enable DelMar to study its lead drug candidate, VAL-083, as a potential treatment for ovarian cancer.
In November 2017, at the annual meeting of the Society for NeuroOncology (SNO), DelMar presented a positive interim update from its ongoing open label Phase 2 clinical trial in patients with MGMT-unmethylated recurrent GBM (rGBM) whose tumors have recurred following treatment with temozolomide (Avastin naïve). This study, which was initiated in February 2017, is being conducted at the University of Texas MD Anderson Cancer Center.
In December 2017, the FDA fully approved Avastin (bevacizumab) which may impact our ability to recruit suitable patients for our STAR-3 Phase 3 clinical trial.
In December 2017, the FDA granted Fast Track designation for VAL-083, in recurrent glioblastoma.
Based on the above developments, and other factors as stated in DelMar's Quarterly Report on Form 10-Q for the quarter ended December 31, 2017 (10-Q) filed with the Securities and Exchange Commission (SEC) on February 14, 2018, DelMar has decided to put the STAR-3 program on hold for up to 12 months and will suspend further site or patient enrollment. This will allow DelMar to fully evaluate the possible impact of Avastin's recent approval by the FDA on patient enrollment for this study, and possible protocol amendments, non-dilutive financing sources, as well as to increase focus on the MGMT-unmethylated clinical studies currently underway as further described in the SEC filings. During this interim evaluation period, DelMar will continue to provide treatment to patients already enrolled in the STAR-3 trial, and consider, on a case-by-case basis, and subject to required institutional and regulatory approvals, providing VAL-083 to patients in accordance with our expanded access policy
Based on this updated strategy, DelMar believes it has cash available into the second quarter of calendar 2019.
For further details on the Company's operating and financial results, as well as more detail about its updated strategy, refer to DelMar's 10-Q filed with the SEC on February 14, 2018, http://ir.delmarpharma.com/all-sec-filings.

VANCOUVER, British Columbia and MENLO PARK, Calif., Dec. 26, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company's lead product candidate, VAL-083, in recurrent glioblastoma (rGBM).

"The Fast Track designation marks an important milestone in the development of VAL-083 as a potential new therapy for cancer patients with limited or no treatment options," said Saiid Zarrabian, interim chief executive officer at DelMar.  "We appreciate the FDA's recognition that the VAL-083 program addresses a significant unmet need in rGBM as we continue to evaluate this agent in patients with multiple tumor types."

This Fast Track status applies to two ongoing clinical trials sponsored by DelMar Pharmaceuticals to evaluate VAL-083 as a potential treatment for rGBM.  These trials include:

A Phase 2 study in bevacizumab-naïve MGMT-unmethylated GBM patients conducted in collaboration with The University of Texas MD Anderson Cancer Center; and
A Phase 3 study of patients whose disease has progressed following prior treatment with temozolomide and bevacizumab (the STAR-3 trial).
Fast track designation is designed to expedite the review of drugs that show promise in treating life-threatening diseases and address unmet medical needs, with the goal of getting new treatments to patients earlier. Fast Track designation provides sponsors with an opportunity for increased frequency of communication with FDA to ensure an optimal development plan and to collect appropriate data needed to support drug approval.

Additional benefits of the Fast Track designation may include an Accelerated Approval, a Priority Review, and a Rolling Review. Accelerated Approval is granted to drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority Review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. Rolling Review provides a drug company the opportunity to submit completed sections of its New Drug Application (NDA) for review by the FDA. Typically, NDA reviews do not commence until the drug company has submitted the entire application to the FDA.  Through the Fast Track designation, the FDA attempts to ensure that questions raised during the drug development process are resolved quickly, often leading to earlier approval and increased access for patients.

Outside of rGBM, DelMar has initiated a Phase 2 clinical trial of VAL-083 in newly-diagnosed MGMT-unmethylated GBM.  DelMar also recently received notice of allowance from the FDA of an IND for a Phase 1/2 trial of VAL-083 in patients with recurrent platinum-resistant ovarian cancer.

"Our ongoing VAL-083 clinical development program is supported by extensive preclinical research into the agent's unique mechanism of action, as well as promising data from prior clinical trials sponsored by DelMar and the National Cancer Institute," added Mr. Zarrabian.  "We are enthusiastic about the potential of VAL-083 to offer a meaningful clinical benefit to patients with rGBM and for the opportunity to expedite the regulatory process through the FDA's Fast Track program."

First Quarter 2018 Financial Results

• No Revenue
• For the quarter ended September 30, 2017, the Company reported a net loss of $2,666,406 or $(0.18) per share, compared to a net loss of $2,290,339, or $(0.23) per share, for the quarter ended September 30, 2016.

"I am extremely pleased with the progress achieved this past quarter across clinical and corporate development fronts. As we transition to a late stage development company with a balanced pipeline of oncology indications, including a pivotal Phase 3 study, I am looking forward to playing an integral role in guiding the company to its next phase of growth," commented Saiid Zarrabian, Interim Chief Executive Officer.

The first quarter of 2018 proved to be an important period for the clinical development of the VAL-083 pipeline of therapeutic candidates. In July, the Company initiated its pivotal Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") and during the quarter enrolled our first patient. The STAR-3 GBM trial is an adaptive design, randomized, controlled, pivotal Phase 3 clinical trial to assess the efficacy and safety of VAL-083 versus salvage therapy in patients with late-stage glioblastoma multiforme (GBM) whose disease has progressed following prior treatment with temozolomide and Avastin, for whom there is currently no standard-of-care therapy. A total of up to 180 eligible patients will be randomized at approximately 25 centers in the United States to receive VAL-083 or "investigator's choice salvage therapy" in a 2:1 fashion. The primary endpoint of the trial is overall survival of VAL-083 versus a control arm consisting of physician's choice of temozolomide, lomustine or carboplatin chemotherapy. The statistical design between the two arms of the study is 90% power, and includes an interim analysis at 50% of events.

In September, DelMar initiated patient recruitment for an open label Phase 2 clinical trial of VAL-083 in newly diagnosed patients with MGMT-unmethylated GBM. The study will enroll 20-30 newly diagnosed GBM patients whose tumors exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) and will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population. The primary efficacy endpoint of this trial is progression free survival (PFS). Results will be used to guide the design of global randomized studies, which if successful, will position VAL-083 as a potential replacement for the current standard-of-care (chemoradiation with temozolomide) in newly diagnosed GBM patients, particularly for the approximately 2/3 of patients whose tumors feature MGMT-unmethylated GBM. Patients with an unmethylated-MGMT promoter express high levels of MGMT, which inhibits the anti-tumor activity of temozolomide, the current standard-of-care chemotherapy used in the treatment of GBM, resulting in treatment resistance and poor patient outcomes.

Also in September, the Company received a notice of allowance from the FDA to commence with a multi-center Phase 1/2 Study of VAL-083 in patients with Recurrent Platinum Resistant Ovarian Cancer ("VAL-083 REPROVe Trial"). Ovarian cancer remains the leading cause of death among women with gynecological cancers and the fifth most frequent cause of cancer deaths in women overall. The American Cancer Society estimates that in 2017, approximately 22,440 women in the US will be diagnosed with ovarian cancer and approximately 14,080 will die from their disease. The majority of these deaths were patients whose tumors had become resistant to platinum-based chemotherapy regimens. Currently, there are no high-efficacy therapeutic options for platinum-resistant ovarian cancer, leaving these cancer patients with very poor prognosis. DelMar plans to initiate the REPROVe trial as soon as practicable.

Throughout the period, DelMar presented new data and promising research results supporting the therapeutic potential of VAL-083 at peer-reviewed scientific conferences. Highlights included, presenting data supporting the effectiveness of VAL-083 in the treatment of GBM at the annual meetings of the American Society for Clinical Oncology ("ASCO"), the American Association of Cancer Research ("AACR"), the World Federation of NeuroOncology Societies ("WFNOS"), the European Association for NeuroOncology and the recent AACR Special Conference on Ovarian Cancer.

On the corporate development front, DelMar continued to enhance its operational capabilities and overall positioning. In September, the U.S. Patent and Trademark Office granted DelMar a new patent covering improved analytical methods related to manufacturing of VAL-083. The patent strengthens the Company's control over VAL-083's manufacturing process. VAL-083 is currently protected by eight US patents and eight patents outside of the US, with issued claims providing patent protection into 2033 in the United States.

In April and September, DelMar completed offerings of common stock and warrants for aggregate gross proceeds of approximately $19.0 million. The Company intends to use the net proceeds of these offerings for clinical trials and general corporate purposes, which may include working capital, capital expenditures, research and development and other business initiatives

VANCOUVER, British Columbia and MENLO PARK, Calif., Oct. 31, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced the presentation of new data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics which was held October 26 -30, 2017 at the Pennsylvania Convention Center in Philadelphia.

DelMar presented a poster entitled "DNA Damaging Agent Dianhydrogalactitol (VAL-083) Targets Homologous Repair (HR) Pathway and Suggests Combination Therapy with topoisomerase inhibitors and PARP inhibitors."   A copy of this presentation can be viewed on the Company's website.  The poster summarizes recent research conducted by DelMar in collaboration with the University of Texas MD Anderson Cancer Center and the Vancouver Prostate Center.  In these studies, VAL-083 was shown to rapidly introduce irreversible DNA interstrand crosslinks leading to persistent DNA double-strand breaks and cancer cell death.  Treatment with VAL-083 induced S/G2 phase cell cycle arrest in all cancer cells tested, including ovarian, prostate, lung and glioma cells.

These results suggest the potential for synergy with treatments that depend on a cancer cell to be in the S-phase for activity.  Such agents include topoisomerase inhibitors, commonly used in the treatment of brain cancer and other solid tumors, and PARP inhibitors, commonly used in the treatment of ovarian cancer. In combination studies, VAL-083 combined with either topoisomerase inhibitors or PARP inhibitors demonstrated synergy or super-additivity against a range of cancer cells.  Topoisomerase inhibitors tested in combination with VAL-083 included etoposide and camptothecin.  PARP inhibitors tested in combination with VAL-083 included olaparib, talazoparib and veliparib.

"We have previously demonstrated that VAL-083 maintains activity against cancer cells resistant to the most commonly used chemotherapies," stated Dr. Dennis Brown, DelMar's Chief Scientific Officer.  "The data presented here expand the opportunity to leverage VAL-083's unique mechanism in combination with agents such as PARP inhibitors and topoisomerase inhibitors that are widely used the treatment of multiple cancers."

"Resistance to treatment can occur when cancer cells, or even a small group of cancer cells within a tumor, contain molecular alterations rendering them insensitive to a particular drug," continued Dr. Brown. "In other cases, cancer cells may adapt to the drug while it is being administered, acquiring molecular changes that allow them to escape its effects.  We are enthusiastic about our results to date with VAL-083 as a single agent, but these data suggest the potential to further improve patient outcomes by combining VAL-083 with other anti-cancer agents that work by a different molecular mechanism.  PARP inhibitors have recently gained significant interest in the treatment of ovarian cancer and are now being explored in multiple cancers.  Topoisomerase inhibitors have been established as important components in the treatment of lung, ovarian, prostate and central nervous system tumors, but their utility can be limited by side effects.  A synergistic combination with VAL-083 offers the potential to improve outcomes while minimizing toxic side-effects.  We look forward to exploring potential combination therapy regimens especially through possible collaborations with companies currently marketing these agents."

VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 28, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced its financial results for the year ended June 30, 2017.   DelMar executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday, October 4, 2017 at 4:30 p.m. Eastern Time.

"We are proud of the progress we have made with our research and clinical programs this past year and look forward to continuing to advance VAL-083 toward ‎commercialization as a new treatment for cancer patients with limited or no options," said Jeffrey Bacha, DelMar's president and chief executive officer.

Due to the completion of the financing earlier in September we had cash and clinical trial deposits on hand of approximately $14.3 million (unaudited) as of the date hereof.

RECENT CORPORATE HIGHLIGHTS

In April and September 2017, completed offerings of common stock and warrants for aggregate gross proceeds of approximately $19.0 million. The Company intends to use the net proceeds of these offerings for its clinical trials and general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. In addition, net proceeds from these offerings may be allocated for acquisitions or investments in businesses, products or technologies that are complementary to Delmar's business.
In July 2017, initiated patient recruitment for the STAR-3 pivotal Phase 3 clinical trial of VAL-083 in refractory GBM and expect to enroll our first patient as soon as practicable.
In September 2017, initiated patient recruitment for an open label Phase 2 clinical trial of VAL-083 in newly diagnosed patients with MGMT-unmethylated GBM, which is being conducted with funding support through DelMar's collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd. This trial complements the Company's ongoing open label Phase 2 clinical trial in patients with MGMT-unmethylated GBM whose tumors have recurred following treatment with temozolomide (bevacizumab naïve), which is being conducted in collaboration with the University of Texas MD Anderson Cancer Center.
In September 2017, received notice of allowance from the FDA for our Phase 1-2 VAL-083 REPROVe clinical trial in Pt-resistant ovarian cancer. DelMar will seek to initiate the REPROVe trial as soon as practicable, subject to negotiating acceptable clinical research agreements and budgets with clinical investigators and their institutions and obtaining IRB approvals.
Presented promising research results supporting the potential of VAL-083 in the treatment of a range of cancers for patients whose tumors exhibit features making them resistant to, or unlikely to respond to, currently available therapies. For example:
Continued to strengthen and expand network of research collaborations with leading academic institutions including the announcement of a major sponsored research agreement with Duke University to evaluate VAL-083 as a front-line treatment for newly diagnosed patients with GBM.
Continued to strengthen the Company's intellectual property portfolio. DelMar now holds eight issued US patents and eight issued patents outside of the US. We have fourteen patent families in various stages of prosecution, and over 100 patent filings in total.
Strengthened Board of Directors and corporate governance with the addition of Saiid Zarrabian and the appointment of Dr. Erich Mohr as independent chairman.

VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 27, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced that it will be presenting an abstract at the American Association for Cancer Research (AACR) Special Conference: Addressing Critical Questions in Ovarian Cancer Research and Treatment, being held on October 1-4, 2017 in Pittsburgh, PA at the Wyndham Grand.

DelMar researchers will present a poster entitled, "Distinct mechanism of action of DNA damaging agent dianhydrogalactitol (VAL-083) suggests combination therapy with PARP inhibitors" on Monday, October 2nd from 6:00PM – 8:30PM EDT.  DelMar's presentation will focus on the mechanism of action (MOA) of DNA damaging agent dianhydrogalactitol (VAL-083) and activity as a single-agent against treatment resistant tumors and opportunities for combination therapy with PARP inhibitors and other common ovarian cancer treatments.  

On September 18th, 2017, DelMar announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug Application (IND) for an open label multi-center Phase 1/2 Study of VAL-083 in Patients with Recurrent Platinum Resistant Ovarian Cancer (VAL-083 REPROVe Trial).  The VAL-083 REPROVe Trial is designed to evaluate the safety and efficacy of VAL-083 in patients with recurrent adenocarcinoma of the ovary, whose cancer has been previously treated with a minimum of two courses of platinum-based chemotherapy, and whose cancer has recurred within six months of the most recent platinum-based chemotherapy.  Further details can be found on clinicaltrials.gov: 

VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 22, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced that it has closed on its previously announced registered direct offering, priced at-the-market.  Pursuant to securities purchase agreements entered into with certain institutional investors, DelMar sold an aggregate of 8,000,000 shares of common stock and warrants to purchase an aggregate of 8,000,000 shares of common stock, at an offering price of $1.25 per share and related warrant, for aggregate gross proceeds of $10 million. The warrants have an exercise price of $1.25 per share, are immediately exercisable, and have a term of exercise of five years.

H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

Net proceeds from the offering are expected to be approximately $9 million.  DelMar currently intends to use the net proceeds of this offering for its clinical trials and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures.  In addition, DelMar may use the net proceeds from this offering for acquisitions or investments in businesses, products or technologies that are complementary to its business.

VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 20, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced that the U.S. Patent and Trademark Office (USPTO) has issued to DelMar, United States Patent No. 9,759,698 covering improved analytical methods for analyzing and determining impurities in dianhydrogalactitol (VAL-083).

DelMar's new patent strengthens the Company's control over the VAL-083 manufacturing process and related controls. DelMar is establishing broad new intellectual property protection around VAL-083, a first-in-class DNA targeting agent that demonstrated clinical activity against a range of tumor-types in prior clinical trials sponsored by the U. S. National Cancer Institute (NCI).  

VAL-083 is currently protected by eight US patents and eight patents outside of the US, with issued claims providing patent protection into 2033 in the United States.  DelMar has made patent filings under 14 separate patent families encompassing more than 100 individual patent applications.

VANCOUVER, British Columbia, and MENLO PARK, Calif., Sept. 18, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced that the U.S. Food and Drug Administration ("FDA") has allowed an additional Investigational New Drug Application ("IND") to study its lead drug candidate VAL-083 as a potential treatment for ovarian cancer.

"The opening of this new IND to study VAL-083 in ovarian cancer marks a major milestone for our Company as we continue to investigate this agent as an important potential therapy for the treatment of multiple cancers," said Jeffrey Bacha, DelMar's president and chief executive officer. 

VAL-083 is a first-in-class, DNA targeting agent that demonstrated clinical activity against a range of tumor-types in prior clinical trials sponsored by the U. S. National Cancer Institute ("NCI").  Published results from NCI studies include recommendations for further study of VAL-083 in advanced clinical trials for ovarian cancer and other gynecologic malignancies.

DelMar's clinical trial will be a multi-center, Phase 1/2 Study of VAL-083 in patients with Recurrent Platinum Resistant Ovarian Cancer ("VAL-083 REPROVe Trial").  DelMar's research demonstrates that VAL-083's unique mechanism of action has the potential to overcome chemo-resistance to platinum-based chemotherapy in ovarian, lung and other solid tumors.

Ovarian cancer remains the leading cause of death among women with gynecological cancers and the fifth most frequent cause of cancer deaths in women overall. The American Cancer Society estimates that in 2017, approximately 22,440 women in the US will be diagnosed with ovarian cancer and approximately 14,080 will die from their disease. The majority of these deaths were patients whose tumors had become resistant to platinum-based chemotherapy regimens.  Currently, there are no high-efficacy therapeutic options for platinum-resistant ovarian cancer, leaving these cancer patients with very poor prognosis. According to published literature, the overall response rate ("ORR") to second line therapy is in the 10-15% range and overall survival is approximately 12-months.

"The development of new treatments to overcome platinum resistance represents the largest unmet medical need in the treatment of ovarian cancer," stated Dr. Bradley J. Monk, MD, principal investigator of the VAL-083 REPROVe Trial and director of the Division of Gynecologic Oncology Research at Arizona Oncology.  "Based on DelMar's recent presentation of pre-clinical data demonstrating activity of VAL-083 against platinum-resistant ovarian cancer, we are enthusiastic about exploring the drug's potential in this important clinical setting."

VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 11, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced the initiation of a Phase 2 clinical trial for its lead agent VAL-083 in newly diagnosed MGMT-unmethylated glioblastoma multiforme (GBM). The biomarker-driven clinical trial will explore safety and efficacy of chemoradiation with VAL-083 as an alternative to standard-of-care temozolomide in patients with MGMT-unmethylated GBM.

"This small trial has the ability to pave the way for a significant treatment paradigm change for patients with newly diagnosed GBM. Positive data from this study will serve as a lead-in to a randomized global trial and set the stage for VAL-083 to potentially become the standard of care for approximately two-thirds of newly diagnosed GBM patients," commented Jeffrey Bacha, Chief Executive Officer of DelMar Pharmaceuticals.

The trial, which is being funded under the terms of DelMar's collaboration with Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma), is being conducted at Sun Yat-sen University Cancer Center (SYUCC) in Guangzhou, China under the direction of Prof. Zhong-ping Chen, M.D., Ph.D.  Prof. Chen is the Chair of the Department of NeuroSurgery/Neuro-Oncology at SYUCC and a member of the editorial board of the Journal of NeuroOncology. 

The study will enroll 20-30 newly diagnosed GBM patients whose tumors exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) and will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population. MGMT methylation status will be used as a biomarker for patient selection and only patients whose tumors are MGMT-unmethylated will be enrolled.

GBM patients with MGMT-unmethylated tumors exhibit a high expression of the MGMT enzyme.   MGMT expression is correlated with resistance to temozolomide, the current front-line chemotherapy used in the treatment of GBM. MGMT-unmethylated patients have particularly poor patient outcomes and significantly reduced survival compared to MGMT-methylated patients. VAL-083 has demonstrated anti-cancer activity independent of MGMT expression against multiple GBM cell lines in vitro.

The primary efficacy endpoint of this trial is progression free survival (PFS). Based on enrollment projections, it is expected that safety/tolerability and primary efficacy (PFS) data from this trial will become available within 9 months and 15 months, respectively from start of enrollment. Results will be used to guide the design of global randomized studies, which if successful, will position VAL-083 as a potential replacement for the current standard-of-care (chemoradiation with temozolomide) in newly diagnosed GBM patients, particularly for the approximately 2/3 of patients whose tumors feature MGMT-unmethylated GBM. Further details of the trial can be found at clinicaltrials.gov (Identifier Number: NCT03050736)

VANCOUVER, British Columbia and MENLO PARK, Calif., July 24, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced that the Human Genetic Resources Administration of China (HGRAC), has approved the Company's application to initiate a Phase 2 safety and efficacy study of its lead product candidate VAL-083 in newly diagnosed MGMT-unmethylated glioblastoma multiforme (GBM). DelMar was required to obtain HGRAC approval because the trial involves analysis of patient's MGMT status as a biomarker for patient selection and enrollment.

"Our clinical trials to date have been focused on recurrent GBM for patients whose tumors have recurred following currently approved therapies. Obtaining HGRAC approval represents a significant step toward maximizing the potential benefit of VAL-083 in newly diagnosed GBM for patients whose tumors exhibit features, such as high expression of MGMT, which render them resistant to the current standard-of-care chemotherapy," said Jeffrey Bacha, Chief Executive Officer of DelMar Pharmaceuticals. "Success of VAL-083 as a front-line treatment would be a major turning point for the brain tumor community and this area of science."

Up to 30 newly diagnosed GBM patients whose tumors exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population. MGMT methylation status will be used as a biomarker for patient selection and only patients whose tumors are MGMT-unmethylated will be enrolled.

Results of the trial will be used to guide design of global randomized trials, which if successful, would position VAL-083 as a potential replacement for the current standard-of-care (chemoradiation with temozolomide) for the approximately 2/3 of newly diagnosed GBM patients whose tumors feature MGMT-unmethylated GBM.

GBM patients with MGMT-unmethylated tumors exhibit a high expression of the MGMT enzyme, which is directly correlated to resistance to temozolomide, the current front-line chemotherapy used in the treatment of GBM. MGMT-unmethylated patients have particularly poor patient outcomes and significantly reduced survival compared to MGMT-methylated patients.

DelMar has demonstrated that VAL-083's anti-cancer activity is independent of MGMT expression against multiple GBM cell lines in vitro. VAL-083's clinical activity against GBM has been established by DelMar's recent Phase 2 clinical trials in refractory GBM and historical trials conducted by the US National Cancer Institute (NCI). Results of prior NCI-sponsored trials of VAL-083 combined with radiotherapy in newly diagnosed GBM suggest a potential superior benefit of chemoradiation with VAL-083 versus radiotherapy alone (+8.3 months) in comparison to similar studies involving temozolomide or nitrosoureas (+1.2 – 2.5 months).

Mr. Bacha continued, "GBM has been largely left behind in the recent advancements made in the fight against cancer and new therapies improving median survival have been lacking. We strongly believe that VAL-083 represents a potential paradigm shift in the treatment of GBM, particularly for the 2/3 of newly diagnosed GBM patients whose tumors exhibit high expression of MGMT."

The trial is expected to open for enrollment in the coming weeks at Sun Yat-sen University Cancer Center (SYUCC) in Guangzhou, China under the direction of Professor Zhong-ping Chen, M.D., Ph.D., who serves as chair of the Department of NeuroSurgery/Neuro-Oncology at SYUCC. Prof. Chen has authored dozens of publications and been involved in numerous international brain tumor trials. He also currently serves as president of the Chinese Society for NeuroOncology and as editor-in-chief of the Chinese Journal of NeuroOncology. Kun Tuo, a subsidiary of QuintilesIMS, has been retained to monitor and oversee the conduct of the trial. Funding support for the trial will be provided by Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma), under the terms of DelMar's collaboration with Guangxi Wuzhou Pharma. Further details of the trial can be found at clinicaltrials.gov (Identifier Number: NCT03050736)

VANCOUVER, British Columbia and MENLO PARK, Calif., July 18, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced the completion of the first site initiation visit at the Dent Neurological Institute ("Dent") for its pivotal Phase 3 Study in Temozolomide-Avastin (bevacizumab) Recurrent GBM ("STAR-3").  Site initiation visits are generally the final step before patient enrollment.

The STAR-3 GBM trial is an adaptive design, randomized, controlled pivotal Phase 3 clinical trial to assess the efficacy and safety of VAL-083 versus salvage therapy in patients with late-stage glioblastoma multiforme (GBM) whose disease has progressed following prior treatment with temozolomide and bevacizumab, for whom there is currently no standard-of-care therapy.

The Dent Neurological Institute is the largest private neurology center in North America seeing more than 250,000 patients annually. Dr. Laszlo Mechtler will serve as principal investigator for the STAR-3 trial at Dent. Dr. Mechtler is Medical Director of Dent Neurologic Institute as well as the Chief of Neuro-Oncology at Roswell Park Cancer Institute in Buffalo, NY. He has contributed to numerous publications and is currently the Principle Investigator of multiple clinical research protocols related to Neuro-Oncology. DelMar anticipates the initiation of additional centers and commencement of treatment under the STAR-3 protocol in the coming weeks.

A total of up to 180 eligible patients will be randomized at approximately 25 centers in the United States to receive either the investigational drug (VAL-083) or "investigator's choice salvage therapy" in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive intravenous VAL-083 at 40 mg/m2 on days 1, 2, and 3 of a 21-day treatment cycle, for up to 12 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation. Up to 60 patients will be randomized to "investigator's choice" control, limited to temozolomide, lomustine, or carboplatin, until they fulfill one of the criteria for study discontinuation.

The primary endpoint of the trial is overall survival of VAL-083 vs. the control arm. The statistical design between the two arms of the study is 90% power, and is proposed to include an interim analysis at 50% events for futility with O'Brien-Fleming superiority boundary and non-binding, gamma (-5) futility boundary. A detailed description of the STAR-3 trial can be found at clinicaltrials.gov, Identifier Number: NCT03149575.

"The activation of the STAR-3 trial and initiation of recruitment in collaboration with Dr. Mechtler and his team at Dent is a momentous occasion for our Company, and for the patients and their families who we hope will benefit from VAL-083," commented Jeffrey Bacha, chief executive officer of DelMar Pharmaceuticals. "In particular, GBM is a type of cancer that has been devoid of new drug approvals improving overall survival for decades, which is why we believe that VAL-083 represents tremendous value in the oncology treatment market. We are pleased to be launching this pivotal study to validate VAL-083's potential by meeting the objectives in the STAR-3 trial."

VANCOUVER, British Columbia and MENLO PARK, Calif., June 22, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, today announced it has received Institutional Review Board (IRB) approval to conduct its pivotal Phase 3 Study in Temozolomide-Avastin (bevacizumab) Recurrent GBM (STAR-3).

"IRB approval is an essential step in initiating patient enrollment in our Phase 3 trial," stated Jeffrey Bacha DelMar's chairman & CEO.  "We are pleased to remain on track to open enrollment in this trial at leading centers in the United States.  Based on our research, we believe that VAL-083 offers significant potential as a new therapy for GBM patients who currently have no viable treatment options."

Under FDA regulations, Institutions Review Boards (IRBs) are required to review all human subject research to ensure that the rights and welfare of human subjects are protected at all times. To accomplish this purpose, IRBs are comprised of physicians and research administrators with the authority to approve, require modifications to, or disapprove research.  The VAL-083 STAR-3 GBM trial and all pertinent study related materials were critically examined by Schulman IRB, the leading independent institutional review board, and approved without any modifications.

About the VAL-083 STAR-3 GBM Trial

DelMar's VAL-083 STAR-3 GBM trial is an adaptive design, randomized, controlled pivotal Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) whose disease has progressed following prior treatment with temozolomide and bevacizumab.

A total of up to 180 eligible patients will be randomized at approximately 25 centers in the United States to receive either the investigational drug (VAL-083) or "investigator's choice salvage therapy" as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive intravenous VAL-083 at 40 mg/m2 on days 1, 2, and 3 of a 21-day treatment cycle, for up to 12, 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation. Up to 60 patients will be randomized to "investigator's choice" control, limited to temozolomide, lomustine, or carboplatin, until they fulfill one of the criteria for study discontinuation.

In both study arms, interval medical histories, targeted physical exams, neurologic evaluations, complete blood counts, and other laboratory and safety assessments will be performed approximately every 21 days while receiving treatment. Tumor assessments are to be performed approximately every 42 ± 7 days while remaining on study. The study is estimated to last less than two years from initiation.

The primary endpoint of the trial is overall survival.  The statistical design between the two arms of the study is 90% power, and is proposed to include an interim analysis at 50% events for futility with O'Brien-Fleming superiority boundary and non-binding, gamma (-5) futility boundary.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes.

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083's anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro.  Further details regarding these studies can be found at http://www.delmarpharma.com/scientific-publications.html.

DelMar's recent outcomes in Phase 1-2 clinical trials suggested that VAL-083 may offer a clinically meaningful survival benefit for patients with recurrent GBM following treatment with both TMZ and bevacizumab.  A well-tolerated dosing regimen of 40mg/m2/day on days 1, 2, and 3 of a 21-day cycle was selected for study in subsequent GBM clinical trials.

DelMar has embarked human clinical trials for VAL-083 across multiple lines of GBM therapy. These trials include, i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab, improves overall survival, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962);  ii) a pivotal, controlled Phase 3 study in temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy (clinicaltrials.gov identifier: NCT03149575);   iii) a single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels (clinicaltrials.gov identifier: NCT03050736). The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM.

VANCOUVER, British Columbia and MENLO PARK, Calif., June 16, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (DMPI) ("DelMar" and "The Company"), a biopharmaceutical company focused on the development of unique new cancer therapies designed to save and improve lives, announced today the presentation of a poster at The Society for Neuro-Oncology's 4th Pediatric Neuro-Oncology Basic and Translational Research Conference. The forum takes place at the Wyndham New Yorker Hotel in New York City on June 15-16, 2017.

The Company's presentation entitled "Dianhydrogalactitol (VAL-083) overcomes p53-mediated chemo-resistance and displays synergy with topoisomerase inhibitors" was presented the evening of Thursday, June 15.

The authors highlight the current absence of a viable standard-of-care for patients with pediatric high-grade gliomas (pHGG). This is because the only approved agent for this indication, temozolomide (TMZ), is rendered inactive due to pediatric brain tumors having a high expression of a TMZ-inactivating enzyme called MGMT* and a low expression of the TMZ-activating MMR** pathway proteins.

In prior clinical trials, DelMar Pharmaceuticals' lead product candidate VAL-083 demonstrated activity against this dire pediatric cancer. The poster emphasizes the fact that VAL-083 maintains functionality regardless of the MGMT or MMR status of pHGG, and is also not affected by the p53 status of the cancer cells. In vitro, VAL-083 has been shown to cause a robust and irreversible S/G2 arrest of the cancer cells, potentially then leading to cancer cell apoptosis. The poster provides the rationale for a detailed clinical investigation of VAL-083 in pediatric high-grade gliomas both as a single agent or in combination with currently available therapies such as TMZ or topoisomerase inhibitors.

*MGMT= 06-methylguanine-DNA methyltransferase
**MMR= mismatch repair

"DelMar Pharmaceuticals is excited to share the promising horizon that VAL-083 results have shown in the treatment of pediatric brain tumor," said Jeffrey Bacha, chairman & CEO of DelMar. "We are conscious of the difference VAL-083 could make in the lives of patients and their families, and we are driven by the determination of improving patient outcomes. We are confident that our research efforts will make an impactful contribution to the community and this area of science."

VANCOUVER, British Columbia and MENLO PARK, Calif., May 18, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced its financial results for the quarter ending March 31, 2017, the third quarter of the Company's 2017 fiscal year. DelMar's executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday May 24th, 2017 at 4:30 p.m. Eastern Standard Time.

"Our recent financing enables us to remain on-track to initiate the pivotal Phase 3 clinical trial of VAL-083 in refractory GBM. This milestone, combined with VAL-083's recent scientific advancements form the foundation for this molecule to serve as a platform asset addressing unmet medical needs in a broad range of tumor types including GBM, non-small cell lung cancer, ovarian cancer and other solid tumors both as a single agent and as a key component of combination therapy regimens," stated Jeffrey Bacha DelMar's chairman & CEO.

In April, the Company announced the closing of a $9 million offering of common stock and warrants which was led by leading healthcare dedicated institutional investors.

During the quarter, the Company made key advancements for VAL-03 as a treatment for GBM patients whose tumors express features, such as high expression of the enzyme MGMT, that make their cancer resistant to, or unlikely to, respond to currently available therapy.  Accomplishments achieved included submitting a protocol to the FDA for a pivotal, controlled Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy for GBM patients who have previously failed both temozolomide (Temodar™) and bevacizumab (Avastin™). The Company also announced a collaboration with PRA Health Sciences ("PRA") as the contract research organization to oversee and manage the Company's pivotal VAL-083 STAR-3 GBM clinical trial. PRA Health Sciences is one of the world's leading global contract research organizations, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA's global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and approximately 13,000 employees worldwide.

During the period, the Company also continued enrolling its Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated GBM at first recurrence/progression prior to bevacizumab (Avastin®) exposure in collaboration with the University of Texas MD Anderson Cancer Center ("MD Anderson"). Additionally, DelMar received ethics committee approval, retained a contract research organization, and submitted an application to the China Office of Human Genetic Resources Authority ("OHGRA") to allow for initiation of the Company's planned Phase 2 clinical trial in newly diagnosed patients with MGMT-unmethylated GBM at Sun Yat Sen University in Guangzhou, China. DelMar also entered into a sponsored research agreement with Duke University to evaluate VAL-083 as a front-line treatment for newly diagnosed patients with GBM.

DelMar also continued to present promising research results supporting the potential of VAL-083 in the treatment of a range of cancers, including GBM, at leading scientific conferences. The Company presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers at the 11th Biennial Ovarian Cancer Research Symposium. Additionally, data was presented indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship. In April, new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer was presented at the American Association for Cancer Research's ("AACR") annual meeting. And in May, the Company presented new research at the 5th Quadrennial Meeting of the World Federation of Neuro-Oncology Societies demonstrating that VAL-083 circumvents both of the primary mechanisms correlated to chemoresistance to temozolomide, the current standard of care in the treatment of GBM.

"GBM represents one of the few cancers that has been largely left behind in the tremendous medical advancements of modern cancer care.  Success in our GBM clinical trials will provide VAL-083 as a new treatment for patients who currently have no viable therapeutic option," said Mr. Bacha.  "Our research with VAL-083 also seeks to expand this opportunity beyond GBM to a wide range of solid tumor patients whose cancer is resistant or unlikely to respond to currently available treatments.  Unlocking the value of VAL-083 for our patients and our shareholders is our primary goal."

VANCOUVER, British Columbia and MENLO PARK, Calif., May 11, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing new cancer therapies, today announced the formalization of an agreement with PRA Health Sciences (PRAH), a leading contract research organization (CRO) to conduct the Company's Phase 3 trial of VAL-083 in recurrent glioblastoma multiforme (GBM).

"We have been working with PRA for quite some time in preparing for VAL-083's Phase 3 study in GBM," said Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals. "Given our recent $9M financing, we have the resources to facilitate the initiation of our pivotal Phase 3 study of VAL-083 as a single agent treatment for GBM patients who have failed both temozolomide (Temodar™) and bevacizumab (Avastin™), for whom there is no currently approved therapy.  We are delighted to formally engage with a CRO of the caliber and reputation of PRA to run this Phase 3 study of a treatment for a cancer indication in which there is an utmost medical need in the eyes of oncologists and the FDA."

PRA Health Sciences is one of the world's leading global contract research organizations by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA's global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and approximately 13,000 employees worldwide. Since 2000, PRA has performed approximately 3,500 clinical trials worldwide and has worked on more than 100 marketed drugs across several therapeutic areas. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 70 drugs.

VANCOUVER, British Columbia and MENLO PARK, Calif., April 25, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it has entered into a three-year collaboration with Duke University to evaluate VAL-083, the Company's platform compound, as a front-line treatment for newly diagnosed patients with glioblastoma multiforme ("GBM").

Under the terms of the collaboration, DelMar will fund a series of pre-clinical studies to be conducted by Duke University's Glioblastoma Drug Discovery Group to evaluate VAL-083, either alone or in combination with other agents, for activity against a range of glioblastoma subtypes (personalized drug development). The goal of the research will be to identify molecular characteristics of GBM tumors that are more likely to respond to VAL-083, and not the standard of care, temozolomide, as a front-line treatment or through combination therapies.

"VAL-083 is a promising drug that has the potential to help many GBM patients, especially the over half of GBM patients whose tumors predominantly exhibit an unmethylated MGMT promoter and do not respond to temozolomide, the current standard of care," commented Dr. Madan Kwatra, Director of the Glioblastoma Drug Discovery Group at Duke University.

GBM is a deadly brain cancer in which the current standard of care consists of surgery followed by radiation and chemotherapy using temozolomide. However, temozolomide only works for about 40% of GBM patients that have a methylated MGMT promoter. In contrast, VAL-083 is a novel chemotherapeutic agent that has activity against GBM with both methylated and unmethylated MGMT promoters. As such, VAL-083 is a more versatile chemotherapeutic agent that may help a wider subset of GBM patients.

"We are delighted to be working with another top-tier research institute and in particular, Dr. Kwatra who is a world renowned expert in the GBM field," stated Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals. "The efforts of his department in the coming years will greatly contribute to our goal of optimizing VAL-083 as a next generation personalized solution for a broad range of cancers."

VANCOUVER, British Columbia and MENLO PARK, Calif., April 21, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it has closed its previously announced registered public offering of an aggregate of 2,769,232 shares of common stock and warrants to purchase an aggregate of 2,076,924 shares of common stock at a price to the public of $3.25 per share and related warrant. The warrants have an exercise price of $3.50 per share, are immediately exercisable and have a term of exercise of five years.

VANCOUVER, British Columbia and MENLO PARK, Calif., April 13, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it has priced a registered public offering of an aggregate of 2,769,232 shares of common stock and warrants to purchase an aggregate of 2,076,924 shares of common stock at a price to the public of $3.25 per share and related warrant. The warrants have an exercise price of $3.50 per share, are immediately exercisable and have a term of exercise of five years. The offering is expected to close on or about April 18, 2017, subject to the satisfaction of customary closing conditions.

Rodman & Renshaw, a unit of H.C. Wainwright & Co., is acting as exclusive placement agent for the offering.

The aggregate gross proceeds of the offering, if completed, are anticipated to be approximately $9,000,000. After deducting the placement agent's fees and other estimated offering expenses payable by DelMar, the net proceeds of the offering, if completed, to DelMar are anticipated to be approximately $8,000,000. DelMar intends to use the net proceeds from the offering for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures.

The shares and warrants are being offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-213601), that was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on September 27, 2016.

VANCOUVER, British Columbia and MENLO PARK, Calif., April 12, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced a proposed registered public offering of its common stock and warrants to purchase common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Rodman & Renshaw, a unit of H.C. Wainwright & Co., is acting as exclusive placement agent for the offering.

DelMar intends to use the net proceeds from the offering, if completed, for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures.

The shares and warrants are being offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-213601), that was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on September 27, 2016. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov and may also be obtained from Rodman & Renshaw, a unit of H.C. Wainwright & Co., by calling (212) 856-5707 or emailing placements@hcwco.com.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

VANCOUVER, British Columbia and MENLO PARK, Calif., Feb. 13, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that patient dosing has commenced in a Phase 2 clinical study of its investigational drug VAL-083 (dianhydrogalactitol) for MGMT-unmethylated Avastin® (bevacizumab)-naïve recurrent glioblastoma.

The first patient was dosed by DelMar's collaborators at the University of Texas MD Anderson Cancer Center in Houston Texas.

"The dosing of the first subject in this VAL-083 trial marks an important milestone in the advancement of our clinical development program targeting MGMT-unmethylated GBM," said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals.

"The majority of newly diagnosed GBM patients' tumors are characterized as MGMT-unmethylated, which is directly correlated with resistance to current standard front-line chemoradiation with temozolomide," added Mr. Bacha. "Our research demonstrates that VAL-083 is active independent of MGMT expression. These data, combined with data from prior clinical trials sponsored by the US National Cancer Institutes that establish VAL-083's activity against GBM, are the foundation of our belief that VAL-083 may provide a new therapeutic option for GBM patients whose tumors exhibit features making them resistant or unlikely to respond to currently available therapy."

The Phase 2 trial will test safety, tolerability and clinical efficacy of VAL-083 in 48 adult subjects with MGMT-unmethylated GBM whose tumors have recurred following surgery and standard chemo-radiation with temozolomide. Patients will receive 40 mg/m2 VAL-083 (IV) on days 1, 2, and 3 of a 21-day treatment-cycle, for up to twelve 21-day treatment cycles to determine if treatment with VAL-083 improves overall survival compared to historical controls. Further information regarding the clinical trial can be found on DelMar's website and at clinicaltrials.gov (clinicaltrials.gov identifier: NCT02717962).

Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT. Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).

Patients whose tumors exhibit a high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 newly diagnosed GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.

VANCOUVER, British Columbia and MENLO PARK, Calif., Feb.13, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced its financial results for the quarter ending December 31, 2016, the second quarter of the Company's 2017 fiscal year. DelMar's executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday, February 15, 2017 at 4:30 p.m. Eastern Standard Time.

"During the past several months, we have increased activities related to our upcoming pivotal Phase 3 clinical trial with our lead VAL-083 program in refractory GBM," said Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals, Inc. We also undertook key steps toward advancing VAL-083 as an alternative to temozolomide in MGMT-unmethylated GBM and into other solid tumor indications for patients whose tumors exhibit features that make them resistant or unlikely to respond to currently available chemotherapies."

RECENT CORPORATE HIGHLIGHTS

DelMar initiated a new Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated GBM at first recurrence/progression prior to bevacizumab (Avastin®) exposure in collaboration with the University of Texas MD Anderson Cancer Center ("MD Anderson").
DelMar continued the advancement of its VAL-083 lead product development program in refractory GBM toward a pivotal Phase 3 clinical trial. DelMar has developed a proposed study design based on feedback from an End of Phase 2 meeting with the United States Food and Drug Administration ("FDA") and input from its clinical advisors. The proposed trial will enroll approximately 180 patients with histologically confirmed recurrent GBM who have failed both standard chemo-radiation and bevacizumab with a primary endpoint of overall survival. Patients will be randomized in a 2:1 fashion to receive either VAL-083 or a commonly used salvage chemotherapy at approximately 25 centers. The proposed study is powered at 90% and will include an interim analysis at 50% of events for futility, superiority and sample size readjustment. DelMar estimates that the proposed study will take less than two years from initiation to completion.
DelMar accessed additional funds to support our research programs through additional non-dilutive funding support from the Government of Canada and the exercise of warrants for cash. The Company estimates that current working capital is sufficient to fund our current operations through the end of calendar 2017.
We continued to obtain promising research results supporting the potential of VAL-083 in a range of treatment-resistant cancer indications:
DelMar presented additional data demonstrating that VAL-083 exhibits a mechanism of action distinct from other chemotherapies used in the treatment of GBM at the annual meetings of the European Association of Neuro-Oncology ("EANO") and the Society for NeuroOncology ("SNO");
DelMar presented data demonstrating that VAL-083 overcomes cisplatin-resistance in ovarian cancer cell lines with known p53 mutations and displays synergy with both cisplatin and AstraZeneca's PARP inhibitor Olaparib™ against ovarian cancer in vitro at the 11th Biennial Ovarian Cancer Research Symposium;
DelMar presented new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer at the American Association for Cancer Research's ("AACR") annual meeting and at the IASLC 17th World Congress on Lung Cancer; and
DelMar presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors at the AACR – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship Conference.
DelMar continued to strengthen its intellectual property portfolio around VAL-083. The Company now holds seven issued US patents and eight issued patents outside of the US. DelMar's patent filings encompass thirteen patent families in various stages of prosecution and over 100 patent filings globally.
"Our excitement about VAL-083 and its potential to extend survival for bevacizumab-failed GBM patients continues to grow as we take steps toward initiating our planned pivotal Phase 3 trial," said Mr. Bacha.

"The recent initiation of a new Phase 2 clinical trial in collaboration with MD Anderson for bevacizumab-naïve MGMT-unmethylated GBM patients, along with a planned trial in newly diagnosed MGMT-unmethylated GBM patients, represent significant steps toward positioning VAL-083 as the chemotherapy of choice for the approximately two-thirds of newly diagnosed GBM patients whose tumors express high levels of MGMT. MGMT is a DNA repair enzyme linked with resistance to currently available chemotherapies including temozolomide and nitrosoureas."

Mr. Bacha continued, "We are also very pleased with our escalating progress to establish VAL-083's potential to address chemo-resistance across a range of cancer indications for patients whose tumors exhibit features that make their cancer resistant or unlikely to respond to currently available therapy. Our research demonstrates the potential of VAL-083 to address unmet medical needs in a range of tumor types including GBM, non-small cell lung cancer, ovarian cancer and other solid tumors."

VANCOUVER, British Columbia and MENLO PARK, Calif., Jan. 25, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, is pleased to announce the opening of enrollment of a Phase II study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, Texas.

The Phase II study of VAL-083 (dianhydrogalactitol) in patients with MGMT-unmethylated, Avastin (bevacizumab)-naïve recurrent glioblastoma will enroll 48 patients in a single-arm design to determine if treatment with VAL-083 improves overall survival, compared to historical control.  Further information regarding the clinical trial can be found on DelMar's website and at clinicaltrials.gov (clinicaltrials.gov identifier:  NCT02717962).

"This study is a keystone in our strategy to expand the development of VAL-083 to target MGMT-unmethylated GBM, a significant unmet medical need," said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals. "We are pleased to launch this important trial in collaboration with the University of Texas MD Anderson Cancer Center, one of the world's most respected medical centers devoted exclusively to cancer patient care, research, education and prevention."

Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT.  Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).

Patients whose tumors exhibit high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar has demonstrated that VAL-083's anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro.  Further details can be found at http://www.delmarpharma.com/scientific-publications.html.

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase III clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase II trial for newly diagnosed GBM patients with an unmethylated MGMT promoter.

VANCOUVER, British Columbia and MENLO PARK, Calif., Dec. 14, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for United States Patent Application Serial No. 13/933,844 entitled, "Improved Analytical Methods for Analyzing and Determining Impurities in Dianhydrogalactitol."

The patent has also been granted in Australia and is being prosecuted in other international jurisdictions as part of more than 100 patent filings from thirteen patent families representing claims covering VAL-083 until 2036.

"This patent provides DelMar with ownership of essential manufacturing controls required under good manufacturing practice (GMP) guidelines," said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. "This is an important component of our strategy to establish a strong international patent portfolio as the foundation to support the global development of VAL-083 in multiple cancer indications."

DelMar is preparing to advance VAL-083 into a pivotal Phase III clinical trial in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

The Company has also recently presented data and outlined plans for expansion of VAL-083 into new indications, including newly diagnosed GBM, ovarian and lung cancer.  DelMar's most recent abstract entitled "Assessment of Dianhydrogalactitol (VAL-083) in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer" was presented at the 17th World Congress on Lung Cancer in Vienna, Austria on December 7, 2016.

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 21, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today summarized the Company's presentations at the CNS Anticancer Drug Discovery and Development Conference and Society for NeuroOncology Annual meeting, which was held November 16-20, 2016 in Scottsdale, Arizona.

During the conference, DelMar's chairman and CEO, Jeffrey Bacha, delivered an oral address during CNS Anticancer Drug Discovery and Development sessions.  Mr. Bacha described DelMar's research and recent clinical trial results and how these data position VAL-083 as a potential solution for newly diagnosed GBM patients whose cancer exhibits features, such as a high expression of MGMT, implicated in resistance to currently approved chemotherapy.

"It was an honor to be invited to share and discuss our research with leaders in the global neuro-oncology community," stated Mr. Bacha. "Overcoming the unique challenges in treating brain tumors requires cooperation among experts across a range of medical and scientific disciplines. We look forward to continuing to advance VAL-083 as a potential new chemotherapy in collaboration with leading cancer centers and researchers." 

DelMar also provided an overview of three upcoming clinical trials with VAL-083 for the treatment of chemo-resistant GBM.  A copy of the company's poster presentation entitled 'Clinical Trials of VAL-083 in Patients with Chemo-Resistant Glioblastoma' can be viewed at http://www.delmarpharma.com/scientific-publications.html. The planned trials include:

1.    A pivotal, randomized multi-center Phase 3 study measuring survival outcomes compared to a "physicians' choice" control for the treatment of bevacizumab-failed GBM.   A summary of the proposed clinical trial design includes:

Approximately 180 patients with histologically confirmed recurrent GBM who have failed both standard chemo-radiation and bevacizumab will be randomized in a 2:1 fashion to receive either VAL-083 or a commonly used salvage chemotherapy;
The proposed study is projected to be enrolled at approximately 25 centers;
The proposed primary endpoint is overall survival (OS);
The proposed statistical design between the two arms of the study is 90% power, and is proposed to include an interim analysis at 50% events for futility with O'Brien-Fleming superiority boundary and non-binding, gamma (-5) futility boundary; and
The estimated length of the proposed study is less than two years from initiation.
The proposed trial design is subject to feedback from the FDA and other regulatory authorities. DelMar plans to submit the protocol to the FDA in coming weeks.

2.    An open label, single-arm, biomarker-driven, Phase 2 study of VAL-083 in patients with MGMT-unmethylated, bevacizumab-naïve recurrent GBM (clinicaltrials.gov identifier:  NCT02717962)

This single arm, biomarker-driven study will enroll 48 patients to determine if treatment of MGMT-unmethylated recurrent glioblastoma with VAL-083 improves overall survival (OS), compared to historical reference control;
The lomustine arm of the recently published EORTC26101 trial will serve as the reference control; and
The study is initially being enrolled at the University of Texas MD Anderson Cancer Center as a single center trial, but may be expanded to include additional centers.
This trial is being conducted in collaboration with the University of Texas MD Anderson Cancer Center ("MDACC").  The MDACC Institutional Review Board (IRB) has approved the protocol for this Phase II Study, and DelMar has completed a formal site initiation visit.  DelMar and MDACC anticipate commencing enrollment and initiating patient treatment in the coming weeks.

3.    An open label, single-arm, biomarker-driven, Phase 2 study of VAL-083 and radiation therapy patients in newly diagnosed MGMT-unmethylated GBM

This single-arm trial will enroll up to 30 newly diagnosed (temozolomide-naïve) GBM patients to examine whether VAL-083 is active in patients with newly diagnosed GBM with MGMT-unmethylated compared to historical control;
If successful, data from the trial will serve as a lead-in to a global randomized Phase II/III clinical trial of VAL-083 in newly diagnosed GBM patients with MGMT-unmethylated;
Progression free survival (PFS) will serve as the primary endpoint to assess VAL-083 treatment activity;
The study will also confirm the safety and tolerability of VAL-083 in combination with a standard-of-care radiation regimen; and
The study will initially be enrolled at the Sun-Yat Sen University (Guangzhou, China) as a single center trial, but may be expanded to include additional centers.
This trial is being conducted in collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co.  Under the terms of the company's collaboration agreement Guangxi Wuzhou Pharmaceuticals is providing drug product and funding for the trial.  The Sun-Yat Sen University Clinical Review Committee has approved the protocol and DelMar is completing the final remaining regulatory steps required for initiation of the trial and expects to begin enrollment in early 2017.

In a separate poster presentation, DelMar provided additional non-clinical data regarding VAL-083's unique anti-cancer mechanism and potential combination therapies.  DelMar's poster presentation, entitled 'Molecular Mechanisms of Dianhydrogalactitol (VAL-083) in Overcoming GBM Chemo-resistance' can be viewed on the company's website at:  http://www.delmarpharma.com/scientific-publications.html.

 First Quarter 2017 Financial Results

• For the three months ended September 30, 2016 the Company reported a net loss of $2,290,339, or a net loss per share of $0.23, compared to a net loss of $1,621,388, or a net loss per share of $0.15 for the three months ended September 30, 2015.

"Looking back, 2016 has been a transformational year for our Company," stated Jeffrey Bacha, DelMar's Chairman and chief executive officer. Our goals this year included listing our company's shares on a national exchange, successfully completing our initial Phase I/II clinical trial in refractory GBM, preparing for a pivotal Phase III clinical trial and expanding our research efforts with VAL-083 into new indications."

VANCOUVER, British Columbia and MENLO PARK, Calif., July 11, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a company focused on developing and commercializing proven cancer therapies in new orphan drug indications, announced today that it has received approval from the Nasdaq Stock Market LLC ("NASDAQ") for the listing of its common stock on the NASDAQ Capital Market.

DelMar's common stock will begin trading on the NASDAQ Capital Market at the opening of trading on Tuesday, July 12, 2016 under the ticker symbol DMPI.  The Company's common stock will continue to trade on the OTCQX exchange until the market close on June 11, 2016.

In honor of the listing, the Company will ring the Opening Bell at the NASDAQ MarketSite in Times Square, New York City, on Thursday, July 14, 2016 (link to live webcast beginning at 9:20 am ET)

"Our listing on the NASDAQ marks the achievement of a major corporate milestone for our Company and is a testament to the progress that our team has made over the past few years," stated Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals.  "We believe that listing on NASDAQ will position us to broaden our shareholder base, increase appeal to institutional investors, provide improved liquidity and ultimately contribute to increasing shareholder value."

VANCOUVER, British Columbia and MENLO PARK, Calif., June 6, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPID) ("DelMar" and the "Company"), a company focused on developing and commercializing proven cancer therapies in new orphan drug indications, presented new data from its recently completed Phase I/II clinical trial of VAL-083 (dianhydrogalactitol) at the American Society of Clinical Oncology's (ASCO) Annual Meeting on Saturday, June 4, 2016.

"This year's ASCO meeting was an opportunity to share the aggregate of our research to date with the global cancer research community," stated Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals.  "Based on our findings related to VAL-083's unique mechanism of action and data from our Phase I/II clinical trial we believe that VAL-083 has the potential to offer a new treatment option for cancer patients whose tumors exhibit features correlated with resistance to currently available chemotherapy."

DelMar's abstract entitled, "Phase I/II Study of Dianhydrogalactitol in Patients with Recurrent Glioblastoma", was presented during the Central Nervous System poster session on Saturday. The poster presentation can be viewed on DelMar's website.

In summary, DelMar's presentation noted:

VAL-083 attacks cancer cells via a unique mechanism of action which is distinct from other chemotherapies used in the treatment of glioblastoma multiforme (GBM).  Specifically, VAL-083 is active independent of MGMT, a DNA repair enzyme which is highly expressed in approximately 2/3 of GBM patients and correlated with resistance to temozolomide, the current front-line chemotherapy in the treatment of GBM.  Of patients tested in the DelMar trial, 84% exhibited high MGMT.
Median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) was 8.35 months, suggesting that VAL-083 may offer improved survival for GBM patients following bevacizumab (Avastin) failure in comparison to currently available salvage therapy. Median survival for VAL-083 treated patients following bevacizumab failure compared with published literature demonstrating survival of approximately three to five months with common salvage therapy regimens.

DelMar's advanced development program will feature a single randomized Phase 3 study measuring survival outcomes compared to a "physicians' choice" control, which, if successful, would serve as the basis for a New Drug Application (NDA) submission for VAL-083.   The control arm will consist of a limited number of salvage chemotherapies currently utilized in the treatment of Avastin-failed GBM. The final pivotal trial design will be confirmed with the FDA following further discussions with the Company's clinical advisors. 

In addition to the pivotal trial, DelMar also plans to initiate two separate Phase II clinical trials in earlier-stage GBM patients.

A randomized, non-comparative, biomarker-driven, Phase 2 study to determine if treatment of MGMT-unmethylated recurrent GBM with VAL-083 or CCNU improves overall survival at 9 months, compared to historical control in bevacizumab naïve patients. (clinicaltrials.gov identifier:  NCT02717962)
A single arm Phase 2 clinical trial to confirm the tolerability of DelMar's dosing regimen in combination with radiotherapy (XRT) and to explore the activity of VAL-083 in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high levels of MGMT.
"We wish to thank the patients, their families, and the physicians who participated in our Phase I/II clinical trial," said Mr. Bacha.  "We are pleased to be advancing VAL-083 into these new trials that we believe, if successful, will serve as the basis for a new treatment paradigm in the treatment of GBM."

Third Quarter 2016 Financial Results

Basic loss per share was $0.12 vs. last year loss $0.11.

"Our data continues to demonstrate VAL-083's unique cytotoxic anti-cancer mechanism which may provide new treatment opportunities for patients whose cancer has failed or is unlikely to respond to currently available therapies. In particular, the data we have presented in our refractory GBM clinical trial positions us to advance this program into registration-directed Phase III clinical trials and we look forward to discussing our proposed trial design with the FDA," said Jeffrey Bacha, DelMar's chairman & CEO.

"Importantly, new funds raised subsequent to quarter end enable us to fund current operations through 2017 and help position DelMar to qualify to list its common stock on a senior exchange."

VANCOUVER, British Columbia and MENLO PARK, Calif., April 21, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for its lead product candidate, VAL-083, in the treatment of ovarian cancer.  The investigational drug candidate previously received an orphan designation for glioma and medulloblastoma in the United States and glioma in Europe.

VAL-083 is a "first-in-class" small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

"We are pleased to receive the designation, which is timely in light of new data presented this week with supporting the potential for VAL-083 in the treatment of ovarian cancer," said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. "This announcement is representative of the progress we've made in developing VAL-083 which we believe positions the therapy as a viable treatment option for ovarian cancer patients."

DelMar's collaborators from the University of Texas MD Anderson Cancer Center (MD Anderson) presented preclinical data demonstrating that VAL-083 appears to have a distinct mode of action from platinum-based chemotherapies widely used in the treatment of ovarian cancer.  In these studies, VAL-083 demonstrated an ability to circumvent cisplatin-resistance in all ovarian cell lines tested.

These new data were presented in a poster entitled, "Enhanced in vitro activity of dianhydrogalactitol (VAL-083) in combination with platinum drugs: Impact of p53 and platinum-resistance," on Monday April 18, 2016 at the annual meeting of the American Association of Cancer Research.

According to Evaluate Pharma, the market for ovarian cancer therapies is expected to be approximately $570 million in 2016 and is projected grow to more than $3.5 billion in 2022. The American Cancer Society estimates that approximately 22,000 women will receive a new diagnosis of ovarian cancer and approximately 14,000 women will die from ovarian cancer in the United States each year. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

Ovarian cancers are commonly treated with a platinum-based chemotherapy regimen.  Initial tumor response rates are relatively high; however, up to 75% of ovarian cancer patients who respond to initial treatment will relapse within approximately 18 months after completing first-line therapy.  Median survival in platinum-resistant recurrent ovarian cancer patients ranged from six to nine months in published studies.

"Ovarian cancer represents the latest indication where our current research, combined with historical clinical activity demonstrated in NCI-sponsored clinical trials, supports our strategy to focus our development of VAL-083 as a new treatment option for ovarian cancer patients who have failed or are unlikely to respond to modern chemotherapeutic regimens," said Mr. Bacha. "We look forward to working with the FDA's Office of Orphan Product Development and leading investigators to advance this program alongside our ongoing efforts in glioblastoma and other solid tumors."

VANCOUVER, British Columbia and MENLO PARK, Calif., April 19, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), today presented updated data from an ongoing Phase I/II clinical trial in refractory glioblastoma multiforme (GBM) with its lead anti-cancer product candidate, VAL-083 (dianhydrogalactitol) at the American Association of Cancer Research (AACR) Annual Meeting in New Orleans.

In summary, DelMar presented that:

A well-tolerated VAL-083 dosing regimen of 40 mg/m2/daily every 3 days in a 21 day cycle has been selected for advancement into a Phase III refractory GBM study;
The Phase III study design and initiation shall be determined in consultation with the USDFA during a meeting planned for the first half of 2016;
The majority of GBM patients enrolled in DelMar's Phase I/II clinical trial have tumors exhibiting features correlated with resistance to currently available therapies, aggressive disease and poor patient outcomes; and
This clinical trial is ongoing with expected median survival of eight to nine months following bevacizumab failure.  Results to date support the potential of VAL-083 to offer a clinically meaningful survival benefit and a promising new treatment option for GBM patients who have failed or are unlikely to respond to currently available chemotherapeutic regimens.
"We are pleased with the continued progress and promise of VAL-083 as a potential new treatment for GBM," said Jeffrey Bacha, DelMar's chairman & CEO.  "We look forward to discussing our plans for advancement into registration-directed Phase III clinical trials with the USFDA in the coming months."

Abstract #CT074, Phase I/II study of VAL-083 in patients with recurrent glioblastoma, was presented as a late-breaking abstract during the "Phase II/III Clinical Trials in Progress" session.

DelMar's Phase I/II protocol was designed to establish a safe dosing regimen for VAL-083 in refractory GBM patients before advancing the agent to larger and more advanced clinical studies.  Enrolled patients must have recurrent GBM and have failed both temozolomide (TemodarTM) and bevacizumab (AvastinTM) unless one or both are contraindicated.

In studies of VAL-083 conducted by the National Cancer Institute (NCI) in the 1970s and 1980s, a variety of dose regimens were used to treat a range of cancers, including GBM. The most common regimen was 25-30 mg/m2/day for 5 days, with re-treatment every 5 weeks.

DelMar's dosing regimen uses a cycle of treatment consisting of intravenous VAL-083 administered on days 1, 2 and 3 of a 3-week cycle.  The three-day dose regimen was developed to be more patient-friendly than a five-day sequence and to take advantage of a shorter platelet nadir and recovery period observed in the literature.

Tumor Response and Outcomes
GBM patients were not re-resected prior to treatment with VAL-083 and therefore had a growing recurrent GBM tumor at the time of enrollment. Patients were monitored for tumor response by MRI.

Consistent with un-resected refractory GBM, median progression free survival (PFS) was short at 1.2 months (range:  0.2 – 20.1 months).  Five GBM patients treated with VAL-083 were reported to have stable disease as their best response following treatment; the remainder reported progressive disease.

Ad-hoc subgroup analysis of the Phase 1 dose-escalation data indicated a dose response trend.  Increase survival was observed at 6, 9 and 12 months following initiation of treatment in a high dose (30 and 40mg/m2) sub-group vs. a low dose (≤5mg/m2) sub-group.

GBM patients failing bevacizumab have a poor prognosis with expected survival under five months.  To date, more than half of patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) have survived more than six months following bevacizumab failure; more than 40% have survived for nine months or are currently alive and more than 20% have survived for twelve months or are currently alive with median survival expected to be determined at between eight and nine months following bevacizumab failure.

The study is ongoing and analysis of patient outcomes is continuing.

MGMT & IDH1
High expression of DNA repair protein O6-methylguanin-DNA-methyltransferase and wild-type form of the enzyme isocitrate dehydrogenase (IDH1) have been correlated with poor outcomes in GBM. The methylation status of the MGMT promoter was characterized by PCR and/or ELISA for nineteen GBM patients enrolled in DelMar's trial; IDH1 status was reported in eleven patients; both MGMT and IDH1 status were reported in four patients.

Of patients tested, 84% exhibited high MGMT and 90% were wild-type IDH1.  All patients whose samples were tested for both markers were MGMT unmethylated by PCR and wild-type IDH1, a genotype that is correlated with particularly poor prognosis.

These data indicate that the majority of patients enrolled in DelMar's clinical trial have GBM tumors that exhibit features correlated with resistance to currently available therapies, aggressive disease and poor patient outcomes.

Pharmacokinetics
Pharmacokinetic (PK) analyses showed dose-dependent linear systemic exposure with a short (1-2h) plasma terminal half-life; average Cmax at 40 mg/m2/day was 781 ng/mL (5.3µM). The observed PK profile is comparable to published literature.  Prior NCI-sponsored studies demonstrated that VAL-083 readily crosses the blood brain barrier and has a long (>20 hour) half-life in the central nervous system.

Based on observed and previously published pharmacokinetics, DelMar believes that therapeutic doses equal to or above 20 mg/m2 daily on days 1, 2 and 3 of a 21 day cycle should deliver sufficient levels of VAL-083 to brain tumors to achieve a therapeutic benefit.

Safety & Tolerability
In the DelMar Phase I dose escalation regimen, no serious adverse events (SAEs) related to VAL-083 were encountered at doses up to 40 mg/m2/day.

Increasing frequency of and higher grade hematologic toxicities were observed at doses above 40 mg/m2/day.  Consistent with the published literature, the observed dose limiting toxicity for VAL-083 is primarily thrombocytopenia.  Observed platelet nadir occurred at approximately day 18, and recovery was rapid and spontaneous following treatment.

Based on Phase 1 observations, fourteen additional patients were enrolled in a Phase 2 expansion cohort at 40mg/m2.

Consistent with Phase 1, the dose of VAL-083 40 mg/m2 on days 1, 2 and 3 of a 21 day cycle was generally well tolerated in Phase 2.  At this dose, one subject previously treated with CCNU reported Grade 4 thrombocytopenia (low platelets).  As a result of this observation, the protocol inclusion criterion for platelet count was increased from 100,000/μL to 150,000/μL for patients receiving prior nitrosoureas within 12 weeks preceding enrollment.  No other dose limiting toxicities were observed at this dose.

Next Steps
DelMar plans to discuss a proposed registration-directed Phase III protocol and data from its current Phase I/II clinical trial with the USFDA in the coming months with a goal of advancing VAL-083 into registration-directed clinical trials for GBM patients who have failed temozolomide and bevacizumab.  Subject to discussions with USFDA and the Company's advisors, along with sufficient financial resources, DelMar hopes to initiate a registration-directed Phase III clinical trial with VAL-083 in refractory GBM within the next six to nine months.

In addition to the proposed Phase III clinical trial, DelMar plans to conduct two additional Phase II studies in separate GBM populations:

In collaboration with the University of Texas MD Anderson Cancer Center, DelMar plans to conduct a randomized Phase II clinical trial of VAL-083 versus CCNU in bevacizumab-naïve MGMT-unmethylated GBM patients at first recurrence/progression to confirm the tolerability of DelMar's dosing regimen and assess outcomes in recurrent bevacizumab-naïve GBM patients whose tumors are known to express high levels of MGMT (clinicaltrials.gov identifier:  NCT02717962); and
In collaboration with Sun Yat-Sen University and Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd, DelMar plans to conduct a single arm Phase 2 clinical trial to confirm the tolerability of DelMar's dosing regimen in combination with radiotherapy (XRT) and to explore the activity of VAL-083 in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high levels of MGMT.
"We believe that the results of these planned studies, if favorable, will position VAL-083 to create a paradigm shift for the majority of GBM for patients whose tumors exhibit molecular features that make them unlikely to respond to currently available chemotherapies," stated Mr. Bacha.

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 23, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, presented updated data from the fully enrolled 14-patient expansion cohort of the Company's ongoing Phase II clinical study of VAL-083 (dianhydrogalactitol) in refractory glioblastoma multiforme (GBM) that is being conducted at Sarah Cannon Research Institute, Mayo Clinic, and UCSF Medical Center.

The data were presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) in San Antonio, Texas, held November 19-22, in a poster entitled, "Phase I/II study of Dianhydrogalactitol (VAL-083) In Patients With Recurrent Malignant Glioma."  Interested parties can access the poster here.

DelMar will host a conference call and live webcast for investors, analysts and other interested parties today at 4:30 p.m. Eastern Time/ 1:30 p.m. Pacific Time to provide a business update and discuss these new data.

"The interim survival data from the Phase II expansion cohort is highly promising and consistent with our observations from the Phase I dose-escalation portion of the trial," stated Jeffrey Bacha, DelMar's chairman & CEO. "A Kaplan Meyer survival estimate, based on these preliminary interim data, projects a greater than 9-month median survival in refractory GBM patients whose tumors have recurred following both front-line therapy with temozolomide and second-line bevacizumab (Avastin^�) treatment." 

"These results continue to support the potential of VAL-083 to address the significant unmet medical need for these patients who currently have no approved therapeutic options," said Mr. Bacha.

"The Phase II portion of the VAL-083 study in patients with recurrent GBM enrolled very quickly. This rapid enrollment, combined with the enthusiasm we have seen from clinical investigators, is a clear demonstration of the overwhelming unmet medical need for new therapies in the treatment of GBM," stated Mr. Bacha.

"The data from the Phase II cohort of our clinical study continue to show that VAL-083 is well-tolerated at the 40 mg/m² dosing regimen.  This dose previously demonstrated the potential to improve survival outcomes in post-bevacizumab refractory GBM," Mr. Bacha continued. "The expanded Phase II data set support 40 mg/m² as the appropriate dose for advancement into registration-directed Phase II/III clinical trials with VAL-083 in patients with recurrent GBM."

"Additionally, we have continued to demonstrate that the cytotoxic mechanism of VAL-083 is distinct from other chemotherapies used in the treatment of cancer.  We can leverage this new understanding of how VAL-083 attacks the tumor with clinical trial data from previously conducted Phase I and Phase II NCI-sponsored clinical trials that validates VAL-083's clinical activity against a range of tumor-types to address modern unmet medical needs in the treatment of cancer," added Mr. Bacha.

"In the case of GBM, we have shown that the anti-tumor activity of VAL-083 is independent of MGMT, the resistance mechanism which causes the majority of GBM patients to fail currently available cytotoxic chemotherapy," said Mr. Bacha.

"Taken together with historical and recently demonstrated clinical activity, these results suggest that VAL-083's distinct anti-cancer mechanism has the potential to overcome chemo-resistance and surpass the standard of care in the treatment of GBM," Mr. Bacha concluded.

DelMar is conducting an open-label, single-arm Phase I/II dose-escalation study with VAL-083 in patients with histologically-confirmed GBM, previously treated with radiation who have failed both front-line therapy temozolomide and second-line Avastin (bevacizumab), and, in most cases, one or more salvage therapies. The study utilized 3+3 dose-escalation design. Patients received VAL-083 on days 1, 2, 3 of a 21-day cycle (ClinicalTrials.gov Identifier NCT01478178) at Sarah Cannon Research Institute, Mayo Clinic, and UCSF Medical Center.

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m² using a regimen of daily x 3 every 21 days. The 40 mg/m²/d dose exhibited a favorable safety profile, with a trend toward improved survival versus lower doses. Following determination of the maximum tolerated dose (MTD) at 40 mg/m²/d, a 14-patient Phase II expansion cohort was rapidly enrolled at a dose of 40 mg/m²/d on day 1, 2, 3 of a 21 day cycle.

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 17, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced its financial results for the first quarter of the 2016 fiscal year ending September 30, 2015. The Company also provided a recap of recent corporate and clinical program highlights and an overview of expected near-term milestones.

DelMar will host a conference call and live webcast for investors, analysts and other interested parties on Monday, November 23rd at 4:30 p.m. ET / 1:30 p.m. PT. During the call, management will provide a business update and discuss DelMar's data presentation at the Society for Neuro-Oncology ("SNO") Annual meeting, which will be held November 19-22, 2015, at the Marriott Riverfront Hotel in San Antonio, Texas.

"We have made tremendous progress in executing our clinical development strategy with VAL-083 in refractory glioblastoma multiforme ("GBM") and identifying additional value drivers through non-clinical research that position us to expand our clinical development efforts into non-small cell lung cancer ("NSCLC") and other solid tumors. We have completed full enrollment of the Phase II expansion cohort in our refractory GBM clinical trial. The results of this study will be the basis for advancing VAL-083 into the planned registration-directed Phase II/III trial in refractory GBM," stated Jeffrey Bacha, president and CEO of DelMar Pharmaceuticals.

"Our clinical development expansion strategy for VAL-083 is proceeding as planned, and we expect to initiate new clinical studies in newly diagnosed GBM and NSCLC patients in the near future," added Mr. Bacha. "Our research collaborations continue to explore the mechanism of VAL-083 and these efforts have unlocked further opportunities for VAL-083 to address unmet medical needs by providing improved treatment options for patients with other tumor types, including ovarian cancer and difficult to treat sub-types of malignant pediatric brain tumors."

RECENT CORPORATE HIGHLIGHTS

• We reported the completion of enrollment in the 14-patient expansion cohort of our Phase II clinical study of VAL-083 in patients with refractory GBM. In addition, we confirmed 40mg/m² as the maximum tolerated dose ("MTD") for advancement into registration-directed clinical trials. This optimized dosing regimen delivers substantially higher doses compared to previous clinical trials conducted by the National Cancer Institutes ("NCI") in the United States. We believe that such higher doses may enhance the potential of VAL-083 to impact a patient's tumor as well as to improve patient outcomes;
• We reported the observation of a promising dose-response trend in the Phase I portion of the clinical trial. A subset analysis of patients in dose cohorts receiving ≥30mg/m² had a median survival of approximately nine (9) months vs. approximately five (5) months in dose cohorts receiving 2;
• We reported additional non-clinical data supporting the favorable differentiation of VAL-083 versus standard of care in the treatment of GBM, non-small cell lung cancer and other solid tumors. We believe these data support the potential of VAL-083 to address the modern unmet medical needs in the treatment of a range of cancers, especially where other therapies have failed or are predicted to give sub-optimal outcomes;
• We announced that the Mayo Clinic Cancer Center in Rochester, Minnesota and the Sarah Cannon Cancer Research Center at HealthOne, Denver, Colorado have had been added as new clinical trial sites in our ongoing, multicenter Phase I/II clinical trial study of VAL-083 in patients with refractory GBM. We now have five clinical sites involved in our study;
• At the American Association for Cancer Research ("AACR") - Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship, we presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors;
• At AACR's Advances in Ovarian Cancer Research: Exploiting Vulnerabilities Conference, we presented data supporting the effectiveness of VAL-083 against cisplatin-resistant ovarian cancers and raised the potential for VAL-083 as a treatment for ovarian cancer as a single-agent against platinum-resistant tumors or in combination with platinum-based chemotherapeutic regimens;
• We announced we have launched a suite of online corporate communication channels to maintain ongoing and direct communication with shareholders and other interested parties. The Company hosts official digital portals on social medial channels including Twitter, LinkedIn,Facebook, Google+ and The Chairman's Blog; and
• We accessed additional capital to support our drug development and research programs through a registered stock offering for gross proceeds of $2.6 million.

"I am extremely pleased with our significant achievements in recent months. DelMar is well positioned for major developments as VAL-083 advances toward registration-directed studies for refractory GBM and into clinical trials for new indications. We anticipate that the VAL-083 program will continue to produce key data during the remainder of 2015 and throughout 2016," concluded Mr. Bacha.

EXPECTED NEAR-TERM MILESTONES

• Present updated safety and efficacy data from the Phase II clinical trial in patients with refractory GBM at the Society for Neuro-Oncology Annual Meeting;
• Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;
• Initiate new clinical trials, including front-line GBM and NSCLC;
• Continue to pursue non-clinical research with VAL-083 as a potential treatment option for chemo-resistant cancers;
• Establish collaboration discussions with leading investigators to advance VAL-083 into clinical studies as a potential treatment for children suffering from recurrent medulloblastoma or high grade gliomas;
• Maximize the value of the VAL083 pipeline through potential partnering opportunities;
• Continue to actively communicate DelMar's progress to the investment and medical communities through presentations at peer-reviewed scientific meetings;
• Continue to build the Company's intellectual property portfolio; and
• Continue to implement strategies to enable DelMar to meet qualifications to list its shares on a national stock exchange.

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 13, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today presented data on the promising potential of VAL-083 (dianhydrogalactitol) as a solution for major unmet needs in the treatment of a variety of cancers.

"Poor outcomes due to drug-resistance remain a significant unmet clinical challenge for many cancer patients. New agents are needed to address treatment-resistant cancers," stated Jeffrey Bacha, DelMar's president and CEO. "Historical clinical data from the U.S. National Cancer Institute (NCI), along with our own preclinical and clinical trial data, all support the activity of VAL-083 against a range of tumor types via a novel mechanism of action that we believe could provide improved treatment options for patients."

DelMar's presentation summarizes the Company's data on the promising potential of VAL-083 across a range of indications.  A poster entitled, "The unique mechanism of action of dianhydrogalactitol (VAL-083) may provide a new treatment option for chemo-resistant cancers," was presented at the American Association for Cancer Research (AACR) New Horizons in Cancer Research Conference: Bringing Cancer Discoveries to Patients in Shanghai, China.

DelMar's presentation highlights the Company's recent research supporting the importance of VAL-083 as a chemotherapeutic agent in the treatment of cancer where resistance to alkylation-based chemotherapy remains an unmet medical need in the modern treatment of cancer and is summarized in the poster presentation as follows:

• VAL-083 activity is independent of O6-methylguanine-DNA methyltransferase (MGMT) expression and overcomes temozolomide (TMZ)-resistance in GBM cell lines;
• VAL-083 overcomes cisplatin-resistance in ovarian cancer and NSCLC cell lines;
• VAL-083 overcomes tyrosine kinase inhibitor (TKI)-resistance in non-small cell lung cancer (NSCLC) cell lines, including H1975 with T790M mutation in EGFR;
• VAL-083 displays synergy and super-additivity with both cisplatin and oxaliplatin in NSCLC cell lines, including TKI-resistant cells in vitro and in vivo;
• VAL-083 activity is independent of p53 status than in comparison to platinum-based chemotherapy; and
• VAL-083 is active against pediatric brain tumors in vitro including high grade gliomas (HGG), GBM cancer stem cells and p53 mutated SHH medulloblastoma.

"The data presented today support expanded clinical use of VAL-083 under its current lung-cancer approval in China and also serve as the basis for global development of VAL-083 in important cancer indications such as GBM, NSCLC and ovarian cancer," added Mr. Bacha. "These data represent important steps toward realizing our vision of leveraging historical clinical data with new research into the mechanism of VAL-083 to address modern unmet medical needs in the treatment of cancer."

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 11, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, presented data on the potential of VAL-083 (dianhydrogalactitol) as a new chemotherapy treatment for malignant pediatric brain tumors.

The Company presented the data in a poster entitled, "Dianhydrogalactitol (VAL-083) Offers Potential Therapeutic Alternatives in the Treatment of Pediatric Brain Tumors," at the American Association for Cancer Research (AACR) Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship conference on Tuesday, November 10, 2015.

"We believe that VAL-083 may be an effective chemotherapeutic alternative for pediatric brain tumors," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "Based on an analyses of historical clinical trials sponsored by the U.S. National Cancer Institute and DelMar's recent clinical and preclinical data, the Company sought to further investigate the cytotoxic activity of VAL-083 against resistant forms of pediatric medulloblastoma and pediatric high grade gliomas cell lines, in vitro."

The data analyses and the in vitro study results detailed in the poster demonstrate that:

• VAL-083 has historical activity in childhood refractory medulloblastoma (MB) and glioblastoma multiforme (GBM);
• VAL-083 overcomes MGMT-related temozolomide (TMZ) resistance in GBM cancer stem cells and non-cancer stem cells cancer stem cells (CSCs) and non-CSCs;
• VAL-083 is active against medulloblastoma cells with SHH characteristics and p53 mutations; and
• VAL-083 in combination with TMZ completely inhibits self-renewal of pediatric GBM cancer stem cells (CSCs).

"The compilation of these data and our recent compelling in vitro results in pediatric MB and HGG warrant the further in vitro research, which will serve as a basis for our clinical development strategy with VAL-083 in pediatric brain tumors," continued Mr. Bacha. "As the next step, we expect to establish discussions with leading clinical investigators in the field in order to undertake the necessary steps to advance VAL-083 into clinical studies as a potential treatment for children suffering from recurrent medulloblastoma or high grade gliomas."

Poster Summary

Medulloblastoma (MB) is the most common malignant pediatric brain tumor, accounting for 15-30% of all childhood intracranial neoplasms. High grade gliomas (HGG) are much rarer in children than in adults, comprising only 5%-10% of childhood brain tumors. Although multidisciplinary treatment has improved the 5-year survival rates in children significantly, the prognoses for recurrent MB and HGG remain poor with a median overall survival of less than one (1) year. Temozolomide (TMZ) is frequently employed in the treatment of MB and pediatric HGG; however, clinical evidence is lacking and poor outcomes due to high-expression of the repair protein O6-methylguanine-DNA methyltransferase (MGMT), which is correlated with TMZ resistance, have been reported.

VAL-083 is a structurally unique bi-functional alkylating agent, whose cytotoxic activity is due to the formation of DNA cross links at the N7. VAL-083 readily crosses the blood brain barrier and has been shown to accumulate in brain tumor tissue. The mechanism of VAL-083 is believed to be distinct from the mechanisms of other alkylating agents commonly used in the treatment of brain cancer (e.g. temozolomide, cisplatin or BCNU). DelMar has recently shown that VAL-083 overcomes TMZ-resistance and cisplatin-resistance, in vitro. VAL-083 has also demonstrated activity against medulloblastoma and glioma cell lines in vitro, including treatment-resistant GBM cancer stem cells (CSC).

In historical NCI-sponsored clinical studies, VAL-083 demonstrated clinical activity against medulloblastoma and high-grade gliomas. In these studies VAL-083 was investigated both as a stand-alone therapy and in combination with other chemotherapeutic regimens. VAL-083 demonstrated clinical activity in a range of brain tumor types, including MB and HGG. Additionally, data from one historical Phase II clinical trial in refractory MB, suggests a lack of cross-resistance between VAL-083 and common chemotherapeutic drugs used in MB treatment, and suggests VAL-083 may be valuable in chemo-resistant medulloblastoma and as part of a combination treatment.

More recently, DelMar has shown that VAL-083 demonstrates cytotoxic activity in glioblastoma (GBM) independent of MGMT expressionin vitro and in vivo. Research has also shown that VAL-083 is highly effective against GBM cancer stem cells (CSC) and non-CSC and acts as a radiosensitizer in GBM cell lines, in vitro. Additionally, in the Company's has recently reported promising data from its ongoing Phase II clinical trial in adult patients with recurrent GBM.

Summary of Proposed Clinical Trial

DelMar's poster also outlined the company's proposed clinical development strategy. Results of further in vitro research will be used to guide clinical strategy for development of VAL-083 as a potential new therapy for treatment of pediatric MB and pediatric HGG. The goal is to stratify patients based on their specific molecular subtype and target VAL-083-responsive difficult-to-treat tumors. However initially, VAL-083 will be tested in recurrent patients with MB or HGG.

"By focusing on 'high-risk molecular' patients stratified based on their molecular subtype, we hope to provide a new treatment option for difficult-to treat pediatric brain tumors such as HGG, and difficult-to-treat medulloblastoma sub-types including SHH patients with p53 mutations and group 3 tumors, ultimately providing a solution to a true unmet medical need," added Mr. Bacha.

Primary goal

• To establish the maximum tolerated dose in children

Secondary goals

• To estimate the efficacy of VAL-083, as measured by objective radiographic response
• To evaluate progression-free survival (PFS) at 6 months
• To evaluate median overall survival (OS)
• To evaluate the safety profile of VAL-083 treatment

The poster presentation and other VAL-083 posters and scientific publications may be found on DelMar's website under http://www.delmarpharma.com/scientific-publications.html.

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083's anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar^�(temozolomide).

DelMar recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m² using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m². Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m². Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (≤5mg/m²) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m² & 40mg/m²) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 10, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced the presentation by its collaborators from the University of British Columbia (UBC) and Vancouver Prostate Centre (VPC) of additional data on the unique molecular signaling events responsible for VAL-083 (dianhydrogalactitol) activity against cancer.

"We continue to demonstrate the therapeutic potential of VAL-083 both as a single-agent and in combination with other treatments," stated Jeffrey Bacha, DelMar's president and CEO. "We have previously shown that VAL-083's anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance. To further understand the unique anti-cancer mechanism of VAL-083, we collaborated with researchers from UBC and VPC to study VAL-083's anti-cancer activity on a molecular level."

These new data were presented on November 9^th by UBC and VPC researchers in a poster entitled, "Exploring the Molecular Mechanisms of Dianhydrogalactitol (VAL-083) in Cancer Treatment," at the 2015 Canadian Cancer Research Conference of theCanadian Cancer Research Alliance (CCRA).

"The study results show a pattern of durability in the DNA lesions caused by VAL-083 which indicate its unique mechanism and potential superiority versus other chemotherapeutic agents. This suggests that VAL-083 is effective at modifying tumor cells and may halt tumor progression by inhibiting natural cellular repair processes," added Mr. Bacha.

"VAL-083's broad anti-cancer activity was established in prior clinical trials sponsored by the U.S. National Cancer Institutes (NCI). Employing modern biological tools to differentiate the mechanisms involved in VAL-083's anti-cancer activity from other chemotherapies provides a basis for future combination treatments as well as guidance for our drug development efforts to concentrate on tumor-types representing significant unmet medical needs," Mr. Bacha stated.

VAL-083 is a bi-functional alkylating agent causing N⁷-guanine methylation and interstrand DNA crosslinks and is approved in China as a chemotherapeutic drug for the treatment of chronic myelogenous leukemia and lung cancer. Preclinical studies and clinical trial data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients.

The goal of this study was to further understand the detailed molecular mechanisms mediating VAL-083 sensitivity or resistance in cancer by investigating the signaling events responsible for VAL-083 activity against cancer. The study confirmed a four-fold hypotheses:

1. VAL-083 induces DNA double-strand breaks (DSBs).
2. VAL-083 cytotoxicity is due to cell cycle arrest and apoptosis resulting from DNA cross-linking lesions accumulating in S- and G2-phases of the cell cycle.
3. The antineoplastic effect of VAL-083 is dependent on cancer cells' ability to repair the VAL-083-induced DNA damage.
4. Alterations in DNA damage repair signaling pathway lead to VAL-083 sensitivity or resistance in tumor cells.

Results indicate that treatment of cancer cells by VAL-083 induces phosphorylation of H2AX, a hallmark of double-strand DNA breaks. H2AX is a histone involved in the CHK2 checkpoint activation pathway, a key component of the body's immune response to DNA damage resulting in down-stream signaling ultimately resulting in apoptosis.

"We will continue to explore the signaling pathways involved in VAL-083 for the treatment of cancer," added Mr. Bacha. "The further elucidation of these molecular mechanisms will help to focus our drug development efforts on patients with cancer who would most benefit from VAL-083 treatment. This 'personalized-medicine' approach leverages significant historical clinical data from prior NCI-sponsored studies; which, when juxtaposed against new understanding of VAL-083's biological mechanism, provides an opportunity to accelerate the development of VAL-083 as a new therapy for cancer patients with limited treatment options."

The research presented at the 2015 Cancer Research Conference was funded in part by financial contributions from Canada's National Research Council's Industrial Research Assistance Program (NRC-IRAP) and Mitacs, a Canadian Network of Centres of Excellence, dedicated to supporting scientific and industrial research.

VANCOUVER, British Columbia and MENLO PARK, Calif., Oct. 21, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that the 14-patient expansion cohort of its Phase II clinical study of VAL-083 (dianhydrogalactitol) in patients with refractory glioblastoma multiforme (GBM) is now fully enrolled.

"We are pleased to confirm that 14 patients have now received at least one course of treatment in the Phase II expansion of this study," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "The fact that we achieved full enrollment far more rapidly than projected, highlights the critical need for new therapies in the treatment of refractory GBM."

Patients enrolled in DelMar's clinical trial have failed both front-line therapy with temozolomide and second-line Avastin and, in most cases, one or more salvage therapies.

"Currently available treatments unfortunately fail to offer any meaningful recourse to slow tumor progression or to extend life in the majority of GBM patients," Mr. Bacha continued. "We believe VAL-083 offers promise as a modern solution to the tremendous unmet medical need for a new therapy for GBM patients who have failed � or are unlikely to respond to � currently available treatments."

Data from the Phase I dose-escalation portion of the multicenter Phase I/II clinical study with VAL-083 in patients with recurrent GBM were presented at ASCO 2015. Dose limiting toxicity was observed at a dose of 50mg/m²/day; no drug-related severe adverse events were reported and myelosuppression was mild at doses <40mg/m²/day.

The Company also provided an update at the GBM2015 scientific meeting on a sub-group analysis for patients receiving up to 5 mg/m² daily x 3 every 21 days (low dose) versus those patients receiving 30mg/m²or 40mg/m² (therapeutic dose) of VAL-083 in the study. The sub-group analysis supports a dose-dependent and clinically meaningful survival benefit in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies. 

DelMar commenced enrollment in the 14-patient expansion cohort for the trial in GBM near the end of the second quarter of 2015 at the University of California, San Francisco, the Mayo Clinic in Rochester, MN and three sites affiliated with the Sarah Cannon Cancer Research Institute in Nashville, TN, Sarasota, FL andDenver, CO. The purpose of the expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at a 40mg/m² dose prior to advancement into registration-directed Phase II/III clinical trials.

To further explore the therapeutic window of VAL-083, DelMar also enrolled three (3) patients an interim dose of 45mg/m².

"Based on the well-tolerated nature of treatment observed at the 40mg/m² dose compared to the dose limiting toxicity observed at 50mg/m², our clinical advisors suggested that exploration of an interim dose at 45mg/m² was warranted," stated Dr. Dennis Brown, DelMar's Chief Scientific Officer. "Preliminary analysis of safety data from the 45mg/m² cohort and from patients enrolled in the Phase II expansion cohort (at 40mg/m²) supports the 40mg/m² dose as an appropriate dose for advancement into registration-directed clinical trials." 

DelMar expects to provide ongoing updates of data during the Phase II trial at oncology and scientific meetings during the remainder of 2015 and into 2016.

Mr. Bacha concluded, "Given that we have now completed enrollment in the Phase II expansion phase of our current study, we remain on track to initiate Phase II/III registration-directed studies within the next nine to twelve months. The design and timing of initiation of the registration-directed clinical trial will depend on review of the data from this clinical study and discussions with the FDA and our clinical advisors."

Further information on the design of DelMar's trial with VAL-083 as a treatment for GBM may be found on the company's website at http://www.delmarpharma.com/clinical-trial.html.

VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 24, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that it has been invited to present an overview of DelMar's clinical strategy with VAL-083 (dianhydrogalactitol) as a potential treatment for non-small cell lung cancer ("NSCLC") at the 16th World Conference on Lung Cancer (WCLC 2015)being held from September 6 - 9, 2015, in Denver, Colorado.

The Company's abstract entitled, "Post-Market Clinical Trial of Dianhydrogalactitol in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer," will be presented on Tuesday, September 8, 2015 from 9:30 a.m. - 4:30 p.m. PDT during a poster session focused on Treatment of Advanced Diseases - NSCLC.

DelMar plans to initiate a clinical trial in NSCLC in collaboration with Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma). Under the terms of the collaboration Guangxi Wuzhou Pharma will fund the planned study and DelMar will be responsible for protocol development and conduct of the trial.  DelMar's goal is to work with Guangxi Wuzhou Pharma to develop new clinical data to help support product growth of VAL-083 in China and to establish clinical proof of concept to expand its independent drug development efforts with VAL-083 as a potential treatment for NSCLC worldwide.

VAL-083 is a "first-in-class" bi-functional alkylating agent that has been approved by the Chinese Food and Drug Administration ("CFDA") for the treatment of lung cancer. However, use of VAL-083 in China has been limited by a lack of modern data, poor distribution, and preference for targeted therapies such as tyrosine kinase inhibitors ("TKIs") in the modern era.

DelMar previously presented a preclinical abstract on VAL-083 in NSCLC at the annual meeting of the American Association of Cancer Research ("AACR") entitled, "In vitro activity of dianhydrogalactitol alone or with platinum drugs in the treatment of NSCLC."  These data demonstrate that VAL-083's mechanism is distinct from platinum-based chemotherapy, the current standard of care for NSCLC and that VAL-083 retains its high level of anti-cancer activity in NSCLC phenotypes, which are highly resistant to current therapy. The data also suggest that the combination of VAL-083 with either cisplatin or oxaliplatin provides a super-additive (synergistic) effect against NSCLC cell lines, including those resistant to TKI therapy in vitro.

DelMar believes these data suggest the potential of VAL-083 to address the modern unmet medical needs in the treatment of NSCLC, especially where other therapies have failed or are predicted to give sub-optimal outcomes.  In addition, VAL-083 readily crosses the blood brain barrier suggesting that it may be possible for VAL-083 to treat patients whose lung cancer has metastasized to the brain.

VANCOUVER, British Columbia and MENLO PARK, Calif., May 29, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, presented additional preclinical data at the American Association of Cancer Research (AACR) Advances in Brain Cancer Research Conference on the potential for its lead product candidate VAL-083 (dianhydrogalactitol) to treat patients with temozolomide-resistant glioblastoma multiforme (GBM).

Dennis Brown, DelMar's co-Founder and Chief Scientific Officer, presented an abstract entitled, "Dianhydrogalactitol inhibits the growth of glioma stem and non-stem cultures, including temozolomide-resistant cell lines, in vitro and in vivo." 

The data from the in vitro portion and the first in vivo segments of the study previously reported at the 2015 AACR annual meeting demonstrated that:

• VAL-083 may be efficacious against both stem and non-stem GBM cell cultures, including those resistant to temozolomide (TMZ);
• VAL-083 maintained anti-tumor activity independent of DNA repair enzyme 0-6-methylguanine DNA methyltransferase (MGMT) resistance mechanism;
• VAL-083 showed an additive effect when combined with radiation in all cultures tested, suggesting that VAL-083 might act as a radiosensitizer in GBM; and
• VAL-083 was effective against GBM in significantly extending survival time in intracranial xenograft GBM models in a dose dependent manner, including in GBM xenografts that are traditionally resistant to TMZ.

Data reported at the AACR Advances in Brain Cancer poster session further examined the activity of VAL-083 in in vivo models of drug-resistant GBM in comparison to TMZ. BT74 animal models bearing intracranial human GBM xenograft tumors of either MGMT-positive or TMZ-resistant origin were treated with VAL-083.

The data demonstrated that VAL-083 may be effective against GBM in extending survival time in intracranial models in a dose-dependent manner. In the first model (U251), median survival time for animals treated with 4 mg/kg VAL-083 was significantly increased to 72 days compared to 48 days for controls (p<0.0001). Median survival time for 3 mg/kg VAL-083 was 54 days. In the second in vivo model (BT74) reported yesterday, the additional data showed that VAL-083 treatment increased survival time in animals bearing intracranial BT74 tumors compared to untreated control. BT74 tumors are traditionally resistant to TMZ.

"VAL-083 has shown encouraging potential to address a significant unmet medical need in GBM patients who fail or are unlikely to respond to today's standard of care. These data continue to further support the potential benefits of VAL-083 in GBM and in our ongoing Phase 1/2 clinical study with VAL-083 as a potential treatment for refractory GBM," stated Jeffrey Bacha, DelMar's president and CEO. "In addition, VAL-083 may offer a potential alternative to the current standard of care, TMZ plus radiation, in newly diagnosed GBM patients whose tumors express high levels of the repair enzyme, O6-methylguanine methyltransferase (MGMT), which is correlated with TMZ resistance and poor patient outcomes."

The standard of care for GBM patients today is surgical resection followed by TMZ and radiation therapy.  MGMT-mediated resistance has emerged as a significant unmet medical need. VAL-083 is an alkylating agent whose cytotoxic anti-cancer mechanism is believed to be via the formation of DNA crosslinks at N⁷ position of guanine. Because these N⁷ adducts appear not to be subject to MGMT-mediated repair, VAL-83 may be an effective chemotherapeutic in the treatment of TMZ-resistant GBM. VAL-083 has been demonstrated to cross the blood brain barrier and accumulate in brain tumor tissue. Previous studies show that TMZ activity is similar in cancer stem cells (CSC) and their paired non-CSC from primary GBM tissues independent of their MGMT expression.

VANCOUVER, British Columbia and MENLO PARK, Calif., April 20, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) (DelMar and the Company), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, today announced updated clinical data on the identification of maximum tolerated dose (MTD) from its Phase I/II study of its lead product candidate VAL-083 (dianhydrogalactitol) in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer.

Results from DelMar's clinical study titled, "Phase I/II study of dianhydrogalactitol in patients with recurrent malignant glioma," were presented during a poster session featuring clinical trials in progress at the 106th Annual Meeting of the American Association for Cancer Research (AACR), being held April 18-22, 2015, in Philadelphia, Pennsylvania.

VAL-083 is a 'first-in-class' small molecule chemotherapeutic, which DelMar is developing as a potential new therapy for the treatment of GBM.  VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

The Company is conducting a multicenter Phase I/II clinical study with VAL-083 to determine the MTD using an optimized dosing scheme. Once MTD is determined, enrollment will be expanded by up to an additional 14 patients in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA) in preparation for advancing VAL-083 into Phase II/III registration directed trials. Based on historical and recent data, in the Phase I/II dose-escalation study there was an observation of Grade 3 and Grade 4 thrombocytopenia (low platelet counts) at the current (50mg/m²).

"While we have only observed one patient with Grade 4 thrombocytopenia, which is defined as dose-limiting toxicity (DLT), in the cohort to date, the strong trend suggested by multiple observations of Grade 3 thrombocytopenia confirm that we have reached the end of the dose-escalation phase of our clinical trial," stated Jeffrey Bacha, DelMar's president and CEO. "Through our optimized dosing regimen, we have successfully achieved our goal of delivering higher doses of VAL-083 than prior promising NCI-sponsored clinical trials with VAL-083 in GBM.  We are pleased to achieve this milestone with VAL-083 as a potential new therapy for GBM patients who fail, or are unlikely to respond to, current standard of care."

"The goal of our current Phase I/II clinical trial is to establish a modernized dosing regimen for advancement into registration directed trials in the United States as a potential new therapy for the treatment of refractory GBM."

"The final decision on the dose chosen for the expansion phase of our Phase I/II trial and advancement into to Phase II/III registration directed studies will be determined by analysis of the totality of the data from the dose-escalation portion of the trial and discussion with our scientific and clinical advisors," added Mr. Bacha.

DelMar's trial is an open-label, single arm, safety and tolerability dose-escalation study utilizing a standard dose escalation design, until the maximum tolerated dose (MTD) or the maximum specified dose has been reached. Eligible GBM inclusion criteria requires previous treatment with surgery and/or radiation, if appropriate. Subjects must have failed both bevacizumab (Avastin^�) and temozolomide (Temodar^�), unless either of these therapies was contraindicated. The study utilizes a 3+3 dose-escalation design (ClinicalTrials.gov Identifier NCT01478178).

The study was designed for patients to receive VAL-083 on days 1, 2, and 3 of a 21-day cycle. Tumor response is assessed according to RANO criteria prior to every other 21-day treatment cycle, and patients exhibiting stable disease or tumor regression remained on VAL-083. Determination of MTD is based on 3+3 design. Currently, 37 patients have been enrolled across 8 dose cohorts ranging from 1.5 to 50mg/m²/d.

In accordance with the protocol, six patients have been enrolled at dose level 8 (50mg/m²/d).  In this cohort, one DLT consisting of Grade 4 thrombocytopenia has been observed at dose level 8  to date and three additional patients in the cohort experienced Grade 3 thrombocytopenia. The DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment. Prior to this cohort, other treatment related toxicities have been mild to moderate. Pharmacokinetic analyses show dose-dependent linear systemic exposure with a short plasma 1-2h terminal half-life; Cmax ranged from 739�1130 ng/mL (5.1�7.7�M) at 40mg/m²/d.

Compared to historical trials, the present regimen delivers substantively more drug as measured by single dose and overall exposure. A dose intensity of 25 mg/m²/wk in combination with radiation was previously shown superior to radiation alone against GBM; a higher dose and dose intensity is achieved by DelMar's dosing regimen in the current trial.

In the dose-escalation portion of the DelMar trial, three GBM patients were observed to have a response (stable disease or partial response) reporting improved clinical signs (maximum response of 84 weeks). In addition, VAL-083 has been assessed in multiple historical NCI-sponsored clinical studies as chemotherapy in the treatment of newly diagnosed and recurrent brain tumors and other cancers. In general, tumor regression in brain cancer was achieved following therapy in greater than 40% of patients treated and stabilization was achieved in an additional 20% to 30%. In published clinical studies VAL-083 has previously been shown to have a statistically significant impact on median survival in high grade glioma brain tumors when combined with radiation versus radiation alone with results similar or superior to other chemotherapies approved for use in GBM.

A Summary of Published Data adapted from Separate Sources Comparing the Efficacy of VAL-083 and Other Therapies in the Treatment of GBM:

In addition to promising historical data, DelMar's research demonstrates that VAL-083's cytotoxic anti-cancer mechanism is different than other chemotherapies approved for the treatment of GBM.   The Company has presented research results at peer-reviewed scientific meetings demonstrating that VAL-083 is active in patient-derived tumor cell lines and cancer stem cells that are resistant to other chemotherapies. Of particular importance is resistance to Temodar due to activity of the repair enzyme known as MGMT, which results in chemoresistance in many GBM patients. At AACR in 2012, DelMar presented data demonstrating that VAL-083 is active independent of MGMT resistance in laboratory studies. VAL-083 has more potent activity against brain tumor cells in comparison to TMZ and overcome resistance associated with MGMT suggesting the potential to surpass the current standard-of-care in the treatment of GBM. 

VANCOUVER, British Columbia and MENLO PARK, Calif., April 16, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) (DelMar and the Company), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, today announced that the Mayo Clinic Cancer Center has been added as a clinical trial site for the ongoing, multicenter Phase I/II study of VAL-083 in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer.

"We are very pleased to add this prestigious institution as our fourth clinical trial site and have the opportunity to collaborate with some of the world's leading oncologists as we advance VAL-083 through clinical development," stated Jeffrey Bacha, DelMar's president and CEO.  "The addition significantly expands our recruitment bandwidth as we seek to advance VAL-083 into Phase II/III registration directed clinical trials as rapidly as possible."

DelMar's trial is an open-label, single arm, safety and tolerability dose-escalation study utilizing a standard dose escalation design, until the maximum tolerated dose (MTD) or the maximum specified dose has been reached. Eligible GBM inclusion criteria requires previous treatment with surgery and/or radiation, if appropriate. Subjects must have failed both bevacizumab (Avastin^®) and temozolomide (Temodar^®), unless either of these therapies was contraindicated.

MTD is determined by treating small cohorts of patients with escalating doses of VAL-083 until a dose limiting toxicity (DLT) is observed in at least two subjects in a given cohort.  Once the MTD is determined, DelMar will expand enrollment at the MTD (or other selected optimum Phase II dose) by an additional 14 patients to gather additional safety and efficacy data prior to advancing into Phase II/III registration-directed trials.

DelMar's modernized VAL-083 dosing regimen takes advantage of improved side-effect management and new knowledge of the pharmacokinetic and toxicity profile of VAL-083 to deliver doses of VAL-083 that are substantially higher than were achieved in prior GBM clinical trials sponsored by the US National Cancer Institutes (NCI).

"Our strategy to 'hit the tumor harder more often' allows us to achieve higher levels of drug at the tumor-site, which we believe will result in significant clinical benefit for GBM patients who currently have no viable treatment options," added Mr. Bacha.

DelMar is currently studying a dose of 50 mg/m² and three patients have completed the required assessments.  At this dose, one patient completed the required safety follow-up period without a DLT. The second patient in the 50 mg/m² cohort experienced myelosuppressive DLT, defined by grade four thrombocytopenia (low platelet counts).  The third patient did not experience a DLT, but did show a strong trend toward DLT, defined by Grade 3 thrombocytopenia. All symptoms of toxicity resolved rapidly and spontaneously returned to normal without concomitant medication or transfusion. 

Based on the observation of one DLT in three patients, DelMar's has enrolled three additional patients in the 50 mg/m² dose cohort prior to confirming MTD or advancing to higher doses. If a DLT is observed in any of these three patients, the highest previous safe dose – 40 mg/m² – would be proposed as the MTD for advancement to registration-directed trials. If no further DLT is observed, DelMar may determine to continue dose escalation to 60 mg/m^2.  However, if continued strong trends toward DLT are observed, DelMar may cease dose-escalation and propose 50 mg/m² as the MTD for advancement into Phase II/III registration directed clinical trials in refractory GBM.

"Based on our current enrollment and timelines, DelMar believes it is likely that we will confirm MTD during the first half of calendar 2015," concluded Mr. Bacha.

DelMar will present a formal update on its progress with its ongoing Phase I/II clinical trial at the American Association of Cancer Research (AACR) Annual Meeting during the "Clinical Trials in Progress" session being held between 8AM and noon EDT on Monday, April 20, 2015.

The VAL-083 Phase I/II clinical trial is also being conducted at three other oncology centers of excellence: The Brain Tumor Center at University of California, San Francisco (UCSF), Calif.; The Sarah Cannon Cancer Research Center in Nashville, Tenn.; and the Sarah Cannon Research Institute affiliate site at the Florida Cancer Specialist Research Institute in Sarasota, Fla. More information on the VAL-083 Phase I/II clinical trial in GBM may be found at http://www.delmarpharma.com/GBM_clinical_trial/.

VANCOUVER, British Columbia and MENLO PARK, Calif., Jan. 12, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar", "the Company) provided an update on the Company's ongoing Phase I/II clinical trial with VAL-083 as a potential new treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.  In addition, DelMar outlined its corporate objectives for 2015. 

Clinical Trial Update

VAL-083 is currently undergoing the dose-escalation portion of a Phase I/II clinical trial in the United States.  The goal of this trial is to establish the maximum tolerated dose (MTD) of VAL-083 in a modernized dosing regimen for advancement into registration directed trials as a potential new therapy for the treatment of refractory GBM. 

The DelMar dosing regimen uses a cycle of treatment on the first three days of every three weeks.  DelMar believes that this modernized dosing regimen, along with improvement in management of myelosuppression in the modern era, provides for more aggressive dosing in comparison to previous  clinical trials sponsored by the US National Cancer Institutes (NCI). 

DelMar is currently studying a dose of 50mg/m² and two patients have completed the required assessments.  The Company's clinical protocol requires acquisition of safety data for 35 days following initial treatment with VAL-083.  At this dose, one patient completed the required 35 day follow-up period without observation of a dose limiting toxicity (DLT). 

The second patient in the 50mg/m² cohort experienced myelosuppressive DLT as defined by grade four thrombocytopenia (low platelet counts).  The patient's symptoms resolved rapidly and spontaneously returned to normal without concomitant medication or transfusion. 

"Historically, dose limiting toxicity observed with VAL-083 was limited to myelosuppression.  This result signals that we are we are nearing the end of the dose-escalation phase of our clinical trial and close to establishing the MTD that we will propose for advancement into a Phase II/III registration trial," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. 

MTD is determined by studying the drug in cohorts of three patients at successively higher doses until a DLT is observed in at least two of the patients in a given cohort.  If a DLT is observed in only one of three subjects, the protocol stipulates that an additional three subjects would be enrolled at that dose, and if one of these additional subjects experiences a DLT, the MTD is then determined.  If no DLT is observed, the trial may proceed to higher dose cohorts.

"If we observe a DLT with the third patient in the 50mg/m² cohort, we would then propose the highest previous dose � 40mg/m² � as the maximum tolerated dose for advancement to registration directed trials," continued Mr. Bacha. 

"However, if no further DLT is observed at 50mg/m², we may determine to continue dose escalation to a higher dose cohort.  Our protocol currently allows dosing up to 60mg/m² and our goal is to maximize the exposure of our drug to the tumor."

DelMar intends to present detailed clinical findings of this study at peer reviewed scientific meetings in 2015.  The Company's most recent data presentations from the 2014 Society for NeuroOncology Annual Meeting can be found on the DelMar Pharmaceuticals website at: http://www.delmarpharma.com/products/publications/. 

2015 Corporate Objectives

DelMar also outlined the Company's corporate objectives for 2015. 

• Complete the dose-escalation portion of the Phase I/II clinical trial and advance VAL-083 into registration-directed clinical trials;
• Advance VAL-083 into additional indications, and seek opportunities to expand our asset base;
• Seek to access additional capital to ensure adequate funding for our research and drug development activities;
• Pursue a national exchange listing for our shares as part of our strategy to maximize shareholder value; and
• Continue to enhance our already strong intellectual property portfolio.

VANCOUVER, British Columbia, MENLO PARK, Calif., and MIAMI, Nov. 17, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and "DelMar Pharma") today announced the presentation of new data supporting the development of VAL-083 (dianhydrogalactitol), which is currently undergoing clinical development in the United States as a potential new chemotherapy for the treatment of refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer.

The data were presented in two additional abstracts on Friday November 14, 2014 during the evening scientific session at the Society for NeuroOncology Annual Meeting. Overall, DelMar presented three abstracts at the meeting. 

On Friday, DelMar announced the presentation of an abstract entitled In vivo efficacy of VAL-083 in the treatment of MGMT-positive glioblastoma multiforme (GBM), which highlighted the company's research into the activity of VAL-083 in comparison to standard-of-care temozolomide in animal models of GBM.

The second abstract entitled VAL-083 is a novel N⁷ alkylating agent that inhibits the growth of glioma stem and non-stem cultures, including temozolomide-resistant lines presented by DelMar's collaborators from the University of California San Francisco (UCSF), provided further pre-clinical validation of VAL-083's different and potentially superior activity compared to standard-of-care temozolomide. 

The third abstract entitled Phase I/II study of dianhydrogalactitol (VAL-083) in patients with recurrent malignant glioblastoma multiforme (GBM) provided an update on DelMar's ongoing Phase I/II clinical trial with VAL-083 in the treatment of refractory glioblastoma. 

Overview of UCSF in vitro Research Findings

"Researchers from UCSF previously demonstrated that the response of both cancer stem cells (CSC) and paired non-CSC cultures isolated from glioblastoma patients to temozolomide, the current standard of care in the treatment of glioblastoma was dependent on the presence or absence of an enzyme called O⁶-methylguanine methyltransferase (MGMT)," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.  "We collaborated with UCSF to investigate how the same cultures respond to VAL-083 alone or in combination with radiation, and how the response would compare to temozolomide."

GBM is the most common and deadly form of human brain cancer.  The standard of care for newly diagnosed GBM patients is surgical resection followed by temozolomide and radiation and subsequent maintenance therapy with temozolomide alone. Temozolomide is effective for a minority of patients that low expression of MGMT, a DNA repair enzyme that repairs the cytotoxic damage temozolomide causes to cancer cells.  The majority of patients exhibit high expression of MGMT and are resistant to temozolomide.

"VAL-083 is a first-in-class alkylating agent that crosses the blood brain barrier and is currently in clinical trials for glioma patients with recurrent GBM.  We hypothesized that the N⁷ alkylating agent, VAL-083, is not subject to MGMT mediated repair and might therefore be a more potent chemotherapeutic for the treatment of GBM," said Joseph Costello, Professor of Neurological Surgery at UCSF.

Patient derived GBM cells were treated with increasing doses of temozolomide or VAL-083 and cell cycle analysis was performed four days after treatment.  VAL-083 proved to be effective against temozolomide resistant cultures, even at single micromolar (uM) doses. 

The activity of VAL-083 and temozolomide were compared by treating CSCs with a 5uM dose of VAL-083 or a 50uM dose of temozolomide in combination with a standard 2 gray (Gy) dose of radiation.  CSCs were examined for cell viability four (4) days post treatment.  The cultures studied were not sensitive to the combination of temozolomide and radiation but were sensitive to treatment with the combination of VAL-083 and radiation.  Further, VAL-083 was shown to increase cancer cells sensitivity to radiation at doses below 2uM.

In summary, UCSF researchers demonstrated that:

• VAL-083 appears to cause cell cycle arrest and loss of cell viability at lower concentrations than temozolomide;
• Unlike temozolomide, VAL-083 is active against stem and non-stem cells and its activity affected by MGMT status. All cultures tested were sensitive to VAL-083 exposure; and
• For all cultures tested, a potential additive effect of VAL-083 with radiation therapy was observed, particularly at low concentrations of VAL-083.

"These in vitro results suggest that VAL-083 may provide greater killing of MGMT unmethylated tumor cells compared to the standard-of-care chemotherapy," added Prof. Costello.

Mr. Bacha added, "While this program is progressing in clinical trials for GBM patients having failed approved therapies we continue believe in the importance of nonclinical research to differentiate VAL-083 not only for continued validation of its promise as a potential treatment for refractory GBM, but also to support its potential as an alternative front-line chemotherapy in the future."

Overview of Clinical Data Presentation:

To date, 13 male and 10 female subjects with GBM have completed safety analysis at doses up to 40mg/m² in DelMar's VAL-083 clinical trial without encountering dose limiting toxicity (DLT).  Seven additional subjects with CNS metastases were enrolled at lower doses; however, enrollment at doses above 5mg/m² has been limited to GBM.

Historical studies sponsored by the US National Cancer Institutes (NCI) achieved promising results in newly diagnosed and recurrent GBM using a dosing regimen of 25 mg/m²/day for five days every five weeks.  Historically, dose limiting hematologic toxic effects were noted on white blood cell (WBC) and platelet counts.  For example, Egan etal. (1979) observed nadir of 2,100/mL (lymphopenia) and 88,000/mL (thrombocytopenia), respectively.  In a separate study, a dose of 40mg/m²/day for five days resulted in a median platelet nadir of 31,000/mL and WBC nadir of 2,300/mL.  In general, nadir occurred within three weeks and returned to normal within seven (7) days.  Anemia, nausea and vomiting were usually mild to moderate.  No renal, hepatic, central nervous system, cardiac, or pulmonary toxicity was identified.

The DelMar dosing regimen uses a cycle of treatment on the first three days of every three weeks.  "We hypothesized that this regimen along with improvement in management of myelosuppression in the modern era would allow for more aggressive dosing and potentially improved patient outcomes," said Mr. Bacha.

"We have now achieved significantly higher doses in comparison to the NCI regimen without encountering dose limiting toxicity," confirmed Mr. Bacha.

Safety Data Summary

DelMar reported that NCI-CTCAE Grade 1 lymphopenia (LLN to >3,000/mL) and thrombocytopenia (platelet counts LLN to >75,000/mL) at doses above 20mg/m²/day x 3 days had been observed in GBM treated to date in the current study; however, no serious adverse events related to study drug or dose limiting toxicity (DLT) has been encountered at doses up to 40mg/m²/day x 3 days.

Mr. Bacha stated, "While low-grade thrombocytopenia and lymphopenia may signal that we are approaching the maximum tolerated dose, we believe that maximizing drug exposure and concentration at the tumor through exploration of higher doses will enhance patient outcomes." 

"We are pleased that our modernized regimen is allowing us to achieve the goal to 'hit the tumor harder more often.' Based on the results to date, we filed a protocol amendment with the FDA and continued dose escalation under our protocol to 50mg/m²." 

In accordance with the protocol, maximum tolerated dose (MTD) will be established by dose limiting toxicity (DLT), defined as:

1. Hematologic DLT
   1. Grade 4 thrombocytopenia (platelets
   2. Absolute neutrophil count (ANC) nadir
   3. ANC
   4. Treatment delays of greater than 3 weeks for hematologic toxicity
2. Non-hematologic DLT
   1. Any grade 3 or 4 non-hematologic toxicity due to treatment with the exception of alopecia, nausea, and vomiting;
   2. Grade 3 or 4 nausea or vomiting while receiving an optimal antiemetic regimen for prophylaxis and management;
   3. Treatment delays of greater than 3 weeks for toxicity

Pharmacokinetic Summary:

DelMar also reported updated pharmacokinetic analyses for cohorts 1-7, which demonstrate dose-dependent linear systemic exposure with a short plasma 1-2 h terminal half-life; Cmax at the highest dose tested (cohort 7, 40 mg/m²) ranged from 1130 to 739 ng/mL (7.7 to 5.1 uM).  These data are correlated with the PK profile published in the scientific literature

"One of the many benefits of the depth NCI-sponsored clinical trial data available to us is the opportunity to correlate our modern data with historical pharmacokinetics," said Mr. Bacha.  "By extrapolating central nervous system (CNS) drug exposure from information in the published literature, we can calculate the expected CNS concentrations based on observed plasma concentrations of VAL-083 in our clinical trial." 

DelMar reported that plasma drug concentrations predict that levels of VAL-083 in brain tissue exceed levels that have been shown to be effective against GBM cell lines in vitro. 

"In other words, while we have not reached the maximum tolerated dose, the drug levels reaching the tumor already are predicted to exceed those shown to be effective in laboratory studies," added Mr. Bacha.

The following table illustrates the estimated concentration in of VAL-083 Human Brain tissue in the 40mg/m² dose cohort compared to the concentration required for activity against GBM cell lines (IC50) in laboratory studies. 

Anti-tumor Activity and Next Steps

The goal of DelMar's Phase I/II trial is to establish the maximum tolerated dose (MTD) of VAL-083 in a modernized dosing regimen for advancement into registration directed trials as a potential new therapy for the treatment of refractory GBM. 

Patients enrolled have recurrent GBM that has failed to respond to prior therapy.  Cycle 1 toxicity is measured for determination of MTD.  Tumor volume is measured via Response Assessment in Neuro-Oncology (RANO) criteria prior to every other 21-day treatment cycle and patients exhibiting stable disease or tumor regression allowed to remain on study drug.   Three patients exhibiting a response (stable disease or partial response) reported improved clinical signs with a maximum response of 28 cycles (84 weeks) prior to discontinuing due to adverse events unrelated to the study. 

To date, no drug-related serious adverse events have been detected and MTD has not been reached at doses up to 40mg/m².  DelMar is currently studying a dose of 50mg/m² in this clinical trial.  The current clinical protocol requires acquisition of safety data for 35 days following initial treatment with VAL-083 in three patients to meet the primary endpoint for determination of MTD.  While patients have been identified for the 50 mg/m² cohort, none have yet completed the required 35 day follow-up period.  Normal instances in clinical development such as patient ineligibility at screening, failure to obtain patient consent or patient death prior to 35 days following dosing may require identification and recruitment of replacement patients.  Once 35-day safety data from three patients in the 50mg/m² cohort is obtained, review of data will either confirm MTD or allow advancement to higher doses. 

"We will work with our clinical advisors to obtain and analyze these data in the timeliest manner possible," said Mr. Bacha.  "Based on our current enrollment and timelines, we believe we remain on track to advance to registration directed trials with VAL-083 in the first half of 2015."

VANCOUVER, British Columbia, MENLO PARK, Calif. and SHANGHAI, Oct. 9, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc., (OTCQB: DMPI), a clinical-stage oncology company, today announced the presentation of promising new data supporting the activity of its lead drug compound, VAL-083, in the treatment of non-small cell lung cancer (NSCLC) at the AACR's New Horizons in Cancer Research: Harnessing Breakthroughs � Targeting Cures. The conference takes place October 9th to 12th in Pudong, Shanghai.

"The data presented today showed that VAL-083 is superior to cisplatin in both tumor models that are sensitive and resistant to tyrosine kinase inhibitors and has synergistic effect in combination with cisplatin," said Jeffrey Bacha, president and CEO of DelMar Pharmaceuticals. "This data suggests important clinical and market potential of VAL-083 in non-small cell lung cancer."

DelMar's lead clinical compound, VAL-083 (dianhydrogalactitol) is a first-in-class alkylating agent with a novel cytotoxic mechanism distinct from other alkylating agents used in the treatment of cancer. 

In historical studies sponsored by the National Cancer Institute in the United States, VAL-083 exhibited clinical activity against a range of tumor types including CNS tumors, solid tumors and hematologic malignancies. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer (Approval No. Guoyao Zhunzi H45021133; manufactured by Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd.)

NSCLC is usually treated with either tyrosine kinase inhibitors (TKIs) (e.g. gefitinib) or platinum-based regimens (e.g. cisplatin). TKIs have resulted in vastly improved outcomes for patients with EGFR mutations; however, TKI resistance has emerged as a significant unmet medical need, and long-term prognosis with platinum-based therapies is poor. Compared to other countries, Asian patients with NSCLC have a higher incidence of EGFR mutations (up to 60 percent; compared to 10-20 percent in Western populations) and are more susceptible to TKI resistance.

Additionally, NSCLC patients have a high incidence of brain metastases, which is associated with a poor prognosis. The median overall survival time for patients with stage IV NSCLC is four months, while one-year and five-year survival is less than 16 percent and 2 percent, respectively. VAL-083 can cross the blood-brain barrier and is currently being evaluated in the United States in a Phase 1/2 clinical trial to treat the most common form of brain cancer, glioblastoma multiforme (GBM).

"Rates of lung cancer have been rising steeply over the past decade and are a significant public health problem in China," explained Mr. Bacha. "China has one-third of the global deaths from lung cancer, and non-small cell lung cancer accounts for more than 85 percent of all lung cancer cases, of which almost half are diagnosed at an advanced stage of the disease. Because VAL-083 is already approved inChina for the treatment of non-small cell lung cancer and has known activity in treating brain cancer, we have the potential to have a near-term option for doctors and millions of Chinese patients who today have not known this treatment was available." 

DelMar's data presented at the AACR New Horizons in Cancer Research meeting seeks to answer three simple, fundamental questions:

• How does the activity of VAL-083 compare to standard platinum therapy? 
• Can VAL-083 be combined with platinum based therapy?
• Can VAL-083 treat NSCLC that is resistant to platinum-based chemotherapy or TKIs?

In in vivo models of lung cancer, significant survival benefit was observed with VAL-083 in comparison to platinum-base chemotherapy in both TKI-susceptible (A549) and TKI-resistant (H1975) models of NSCLC.  These observations suggest that VAL-083 maintains activity where cisplatin fails to gain a statistically significant benefit.

In a separate, standard model of anti-cancer activity, VAL-083 was superior to cisplatin in tumor growth delay. Interestingly, VAL-083 in combination with cisplatin produced a more than additive effect by delaying growth in vivo.  These observations are supported by separate in vivo studies which reveal the potential for synergistic benefit for a combination of VAL-083 and platinum-based therapies against both TKI-susceptible (A549) and TKI-resistant (H1975) NSCLC tumor cell lines.

Taken together, the results suggest that VAL-083 is superior to cisplatin in both TKI-sensitive and resistant tumor models, has synergistic effect in combination with cisplatin, and suggest clinical potential in TKI-resistant NSCLC. This data provides direction to clinical research aimed at influencing practice patterns under VAL-083's current approval in China and support expanded global development.

"We believe these observations have important immediate implications in the treatment of NSCLC in China, where VAL-083 is approved for as chemotherapy for the treatment of lung cancer, and for future clinical development in the rest of the world," added Mr. Bacha.  "Next steps include clinical validation of these promising results in a clinical study. Such work could be initiated in China in a post-approval setting."

Details of the company's presentation will be posted DelMar's website under http://www.delmarpharma.com/products/publications/ 

DelMar Pharmaceuticals and Guangxi Wuzhou Pharmaceuticals are collaborating in the development of VAL-083 in China.  DelMar is also this product in Phase I/II clinical trials in the United Stated as a potential treatment for refractory glioblastoma multiforme (clinicaltrials.gov identifier:  NCT01478178).