VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 17, 2015 -- DelMar Pharmaceuticals, Inc. (DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, today announced an increase in funding of up to CDN$287,000 from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) to support an ongoing research project. With the increase, NRC-IRAP's total non-refundable financial contributions to DelMar total CDN$420,000 to date.
"We are very pleased with the continued support to accelerate and expand our non-clinical research to further establish the competitive differentiation of our lead product candidate VAL-083," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "We have made tremendous progress this year executing on our clinical development strategy with VAL-083. These additional funds, along with support from the technological expertise and advisory services provided by NRC-IRAP, will be invaluable as we continue to advance VAL-083 in refractory glioblastoma multiforme (GBM) and expand its utility in other tumor types."
This most recent funding builds upon previous non-repayable contributions from NRC-IRAP totaling CDN$133,000 that supported research conducted in collaboration with University of British Columbia, the Vancouver Prostate Centre and the B.C. Cancer Agency. The increase in funding reflects the success of this research program to date. The results of the collaborative project, funded in part by the NRC-IRAP, support differentiation of the anti-cancer mechanism of VAL-083 and its potential as a treatment for other tumor types beyond its current Phase II GBM clinical trial into non-small cell lung cancer (NSCLC) and other solid tumors.
DelMar's drug development program leverages numerous preclinical and clinical Phase I/Phase II historical research studies in which VAL-083 demonstrated activity, safety and efficacy in treating a wide range of tumor types including lung, brain, cervical and ovarian cancers. The Company intends to expand its clinical development program for VAL-083 into NSCLC and other solid tumors to target specific unmet medical needs in major cancer indications.
DelMar recently presented interim data of its ongoing Phase I/II clinical trial in patients with recurrent GBM at the American Association of Clinical Oncology (ASCO) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose greater than or equal to 30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses less than 10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.
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). 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 causes chemotherapy resistance to 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.
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: firstname.lastname@example.org / (604) 629-5989. Follow us on Twitter @DelMarPharma or Facebook.com/delmarpharma. Investor Relations Counsel: Amato & Partners LLC.
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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