Update on DelMar’s Phase I/II Refractory GBM Clinical Trial with VAL-083 to be published as a late-breaking abstract on April 19, 2016
VANCOUVER, British Columbia and MENLO PARK, Calif., March 24, 2016 /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 will present three abstracts at the American Association of Cancer Research (AACR) Annual Meeting based on pre-clinical research conducted with its lead anti-cancer product candidate, VAL-083 (dianhydrogalactitol), a “first-in-class” small-molecule chemotherapeutic agent.
The Company’s first two abstracts have been published and can be viewed on the AACR Annual Meeting website.
DelMar will present abstract (#2157): “Enhanced in vitro activity of dianhydrogalactitol (VAL-083) in combination with platinum drugs: Impact of p53 and platinum-resistance,” during the session entitled “New Drugs, Therapeutic Targets, and Treatment Approaches being held on Monday, April 18, 2016, from 1:00 p.m.-5:00 p.m. CDT. In this abstract, the Company will present new in vitro data in cell-lines representing difficult to treat subsets of non-small cell lung and ovarian cancer that may be targeted by VAL-083’s unique anti-cancer mechanism.
A second abstract (#2985): “Molecular mechanisms of dianhydrogalactitol (VAL-083) in cancer treatment,” will be presented during the session entitled New Mechanisms of Anticancer Drug Action being held on Tuesday, April 19, 2016, from 8:00 a.m.-12:00 p.m. CDT. In this abstract, DelMar will present new data related to VAL-083’s mechanism of action, which may lead to opportunities to treat resistant cancer phenotypes and to beneficial combination therapy approaches in the treatment of cancer.
DelMar will also present an update on its ongoing “Phase I/II study of VAL-083 in patients with recurrent glioblastoma,” as a late-breaking abstraction during the Phase II/III Clinical Trials in Progress session on Tuesday, April 19. Details of this abstract (#CT074) will be published during the session beginning at 8:00 a.m. CDT.
VAL-083 is a “first-in-class,” small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas. DelMar recently announced that the FDA’s Office of Orphan Products had also granted an orphan designation to VAL-083 for the treatment of medulloblastoma.
DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar® (temozolomide).
DelMar has been conducting a Phase I/II clinical trial in GBM patients whose tumors have progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.
Sub-group analysis of data from the Phase I dose-escalation portion of the study suggests a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083. Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar also reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.
VAL-083 is well tolerated using a regimen of 40mg/m2 daily x 3 every 21 days. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed at doses above 40 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment.
Based on these data, DelMar initiated a Phase II expansion cohort utilizing the 40mg/m2 dosing regimen in June 2015 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). DelMar announced the completion of enrollment in a Phase II expansion cohort in September, 2015.
Further details can be found here
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in 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 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 www.delmarpharma.com;
DelMar Pharmaceuticals Investor Relations: email@example.com
Tel: (604) 629-5989.
Investor Relations Counsel: Amato & Partners LLC.
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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.
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