DelMar Pharmaceuticals Announces Peer-Reviewed Publication of Interim Results of Phase 2 Clinical Trial of VAL-083 As First-Line Treatment in Newly-Diagnosed MGMT-Unmethylated Glioblastoma Multiforme
February Issue of "Glioma" Highlights Positive Progression-Free Survival Data
SAN DIEGO, Jan. 29, 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 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 the Company's 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 article can be accessed online via http://www.jglioma.com/article.asp?issn=2589-6113;year=2019;volume=2;issue=4;spage=167;epage=173;aulast=Guo.
In the article, which was co-authored by lead investigator Professor Zhong-ping Chen of Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, where the study is currently being conducted, of the 22 patients who had completed at least one cycle of treatment as of that date, median progression-free survival (PFS) with VAL-083 as reported was 9.9 months (confidence interval, or CI, 7.3-12.0 months). For the 18 patients initially receiving the intended treatment dose (30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median PFS as reported was 10.4 months (CI 6.0-12.0 months). While this is not a head-to-head trial, historically, temozolomide (TMZ) has been demonstrated to have 6.9 months PFS in unmethylated GBM patients.
"This publication represents an important additional validation of VAL-083 as a first-line treatment. Given that an external panel of experts reviewed both the protocol and the interim data and were willing to publish based on the results and inclusive of the fact that the data came from a study originating in China. This publication is from a world-renowned journal and we believe it demonstrates the potential to achieve one of the first new treatments for GBM in many years. We look forward to providing continued updates on the development of VAL-083 as they become available," commented Saiid Zarrabian, DelMar's Chief Executive Officer.
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. In the publication, authors outlined the two parts of the study. The first is a dose escalation and induction format to enroll up to ten patients to receive VAL-083 at 20, 30 or 40 mg/m2/day for three days every 21 days concurrently with standard radiation and VAL-083 for up to eight additional cycles. The second part of the study is an expansion phase to enroll up to 20 additional patients. The publication highlighted the first 23 patients enrolled, 14 of whom had been treated in the expansion phase.
Myelosuppression was the most common adverse event in the patients assessed, and pharmacokinetic assessments indicated that the levels of VAL-083 were as high in the cerebrospinal fluid as in plasma two hours after infusion.
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:
About DelMar Pharmaceuticals, Inc.
Located in San Diego, California, 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 National Cancer Institute (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, including statements regarding the status of the Company's clinical trials and the reporting of the results. 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, 2019, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
Director of Public Relations
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SOURCE DelMar Pharmaceuticals, Inc.
Released January 29, 2020