VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 27, 2017 /PRNewswire/ -- DelMar Pharmaceuticals (NASDAQ: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: https://www.clinicaltrials.gov/ct2/show/NCT03281681?term=val-083&rank=3
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. In 2016, approximately 22,300 women in the US were diagnosed with ovarian cancer and 14,300 died from their disease. The vast 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.
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 (NCI).
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 is currently being studied in multiple clinical trials as a potential new treatment for glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
DelMar has demonstrated that VAL-083's mechanism of action is distinct from multiple chemotherapies widely used in the treatment of cancer and that this unique mechanism may offer opportunities to overcome treatment resistance thereby offering new treatment options to cancer patients. Further details regarding these studies can be found at http://www.delmarpharma.com/scientific-publications.html.
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 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 have become intolerable to modern targeted or biologic 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 across multiple oncology indications to solve significant unmet medical needs.
Delmar has initiated a pivotal, randomized Phase 3 Study in Temozolomide-Avastin Recurrent GBM (STAR-3). Outcomes in DelMar's recent Phase 1-2 clinical trials suggest that VAL-083 may offer a clinically meaningful survival benefit for this patient population.
VAL-083 is also being studied in two collaborator-supported, biomarker driven, Phase 2 clinical trials for MGMT-unmethylated GBM. These trials are designed to position VAL-083 as a potential therapeutic alternative for the majority of GBM patients whose tumors exhibit high expression of MGMT, a biomarker correlated with resistance to the current standard-of-care chemotherapy. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM.
The VAL-083 REPROVe trial is designed to evaluate explore VAL-083 in platinum-resistant ovarian cancer. Resistance to platinum-based chemotherapy represents a significant unmet medical need in the treatment of 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: [email protected] / (604) 629-5989.
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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. Such forward-looking statements include, among other thing, statements regarding the expected use of proceeds. 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-
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SOURCE DelMar Pharmaceuticals, Inc.
