August 24, 2015 – DelMar Pharmaceuticals Inc.
VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 24, 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 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.
VAL-083 is a “first-in-class”, small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. 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.
DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA) 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). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that is implicated chemotherapy resistance and poor outcomes following front-line treatment with Temodar® (temozolomide).
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company’s lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China. Published pre-clinical and clinical 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.
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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. 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.