DelMar Pharmaceuticals Presents Positive Updates on Two Ongoing Clinical Trials with VAL-083 for Treatment of MGMT-unmethylated GBM

PRNewswire 17-Apr-2018 2:00 PM

DelMar Pharmaceuticals Presents Positive Updates on Two Ongoing Clinical Trials with VAL-083 for Treatment of MGMT-unmethylated GBM

- Updates Provided in Two Poster Presentations at Annual Meeting of the American Association for Cancer Research -

PR Newswire

VANCOUVER, British Columbia and MENLO PARK, Calif., April 17, 2018 /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 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recurrent GBM, will be enrolled to determine if treatment with VAL-083 improves overall survival compared to historical reference control.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.

DelMar's poster presentations can be viewed on the company's website at: 

http://www.delmarpharma.com/scientific-publications.html

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 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 in vitro. Further details regarding these studies can be found at: 

http://www.delmarpharma.com/scientific-publications.html.

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.  VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.

About DelMar Pharmaceuticals, Inc.

DelMar Pharmaceuticals is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options.  By developing an understanding of tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or have become intolerable to, modern targeted or biologic treatments.

The Company's current pipeline centers around VAL-083, a "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head & neck) in U.S. clinical trials sponsored by the NCI.  Based on DelMar's internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 across multiple oncology indications to solve significant unmet medical needs.

DelMar is currently studying VAL-083 in two collaborator-supported, biomarker driven, Phase 2 clinical trials for MGMT-unmethylated GBM.  Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM.  DelMar also recently announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

Further information on DelMar's clinical trials can be found on clinicaltrials.gov: 

https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs

For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989.

Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K.

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SOURCE DelMar Pharmaceuticals, Inc.

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