VANCOUVER, British Columbia and MENLO PARK, Calif., May 6, 2019 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) (“DelMar” or the “Company”), a biopharmaceutical company focused on the development of new cancer therapies, on May 3, 2019 presented data supporting Dianhydrogalactitol (VAL-083) as a potential therapy for pediatric brain tumors at the Society for Neuro-Oncology (SNO) Pediatric Neuro-Oncology Basic and Translational Research Conference held May 3-4, 2019 in San Francisco, CA. The Company, which has been working in collaboration with investigators from the University of California, San Francisco (UCSF), University of British Columbia, and the Vancouver Prostate Centre on evaluating VAL-083 as a treatment for diffuse intrinsic pontine glioma (DIPG), an extremely aggressive brain tumor, presented promising in vivo DIPG model data demonstrating VAL-083’s potential as a single agent, and in combination with Wee1 inhibitor AZD1775, in significantly prolonging survival.
VAL-083 presentation highlights as a treatment for DIPG included:
- As a single agent significantly increases median survival in DIPG in vivo compared to untreated controls
- In combination with AZD-1775, a Wee1 inhibitor, further increases survival in DIPG in vivo
- Is active against DIPG cell lines with varying genetic profiles including p53, H3.3/H3.1 and K27M mutations
- Is synergistic with AZD1775 against DIPG and pediatric GBM cell lines
“We are encouraged by this data that demonstrates VAL-083’s ability as a single agent and in combination with Wee1 inhibitor AZD1775 to significantly increase survival in an in vivo DIPG model. An intact blood-brain barrier impeding drug penetration is a major obstacle to successful treatment of DIPG and VAL-083’s ability to concentrate in the cerebral spinal fluid (CSF) may offer an important advantage,” commented Dr. Sabine Muller, Associate Professor of Clinical Neurology, UCSF.
DIPG is a difficult-to-treat, inoperable, rare pediatric brain tumor with very poor prognosis and a dismal survival outlook. Approximately 300 children in the U.S. are diagnosed with DIPG each year. While DIPGs are usually diagnosed when children are between the ages of 5 and 9, they can occur at any age in childhood. These tumors occur in boys and girls equally and do not generally appear in adults.
“While it’s certainly early in the evaluation process for the DIPG indication, I’m extremely pleased by these results demonstrating VAL-083’s potential in this difficult-to-treat pediatric brain cancer population. I am also encouraged to see the potential therapeutic benefit afforded by VAL-083 due to its ability to concentrate in the CSF. Recent data reported at the American Association for Cancer Research annual meeting in April 2019 from our clinical study for newly-diagnosed, adult, unmethylated MGMT GBM patients demonstrated that drug levels in the CSF were generally higher in comparison to plasma levels at two hours after administration. This compares favorably to standard of care temozolomide where CSF concentration levels are approximately 80% lower than in plasma and may offer an important advantage for VAL-083,” commented Saiid Zarrabian, DelMar’s Chief Executive Officer.
VAL-083 (dianhydrogalactitol) is a “first-in-class,” bifunctional 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, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:
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. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.
About DelMar Pharmaceuticals, Inc.
DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.
The Company’s current pipeline is based 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 to solve significant unmet medical needs.
VAL-083 is being studied 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. In addition, DelMar has 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
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 the Company’s filings with the SEC, including, the Company’s Annual Report on Form 10-K for the year ended June 30, 2018, the Company’s Quarterly Reports on Form 10-Q, and the Company’s Current Reports on Form 8-K.
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