On February 13, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the quarter ending December 31, 2016, the second quarter of the Company’s 2017 fiscal year (Press release, DelMar Pharmaceuticals, FEB 13, 2017, View Source [SID1234517706]). DelMar’s executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday, February 15, 2017 at 4:30 p.m. Eastern Standard Time. Schedule your 30 min Free 1stOncology Demo! "During the past several months, we have increased activities related to our upcoming pivotal Phase 3 clinical trial with our lead VAL-083 program in refractory GBM," said Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals, Inc. We also undertook key steps toward advancing VAL-083 as an alternative to temozolomide in MGMT-unmethylated GBM and into other solid tumor indications for patients whose tumors exhibit features that make them resistant or unlikely to respond to currently available chemotherapies."
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RECENT CORPORATE HIGHLIGHTS
DelMar initiated a new Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated GBM at first recurrence/progression prior to bevacizumab (Avastin) exposure in collaboration with the University of Texas MD Anderson Cancer Center ("MD Anderson").
DelMar continued the advancement of its VAL-083 lead product development program in refractory GBM toward a pivotal Phase 3 clinical trial. DelMar has developed a proposed study design based on feedback from an End of Phase 2 meeting with the United States Food and Drug Administration ("FDA") and input from its clinical advisors.
The proposed trial will enroll approximately 180 patients with histologically confirmed recurrent GBM who have failed both standard chemo-radiation and bevacizumab with a primary endpoint of overall survival. Patients will be randomized in a 2:1 fashion to receive either VAL-083 or a commonly used salvage chemotherapy at approximately 25 centers. The proposed study is powered at 90% and will include an interim analysis at 50% of events for futility, superiority and sample size readjustment. DelMar estimates that the proposed study will take less than two years from initiation to completion.
DelMar accessed additional funds to support our research programs through additional non-dilutive funding support from the Government of Canada and the exercise of warrants for cash. The Company estimates that current working capital is sufficient to fund our current operations through the end of calendar 2017.
We continued to obtain promising research results supporting the potential of VAL-083 in a range of treatment-resistant cancer indications:
DelMar presented additional data demonstrating that VAL-083 exhibits a mechanism of action distinct from other chemotherapies used in the treatment of GBM at the annual meetings of the European Association of Neuro-Oncology ("EANO") and the Society for NeuroOncology ("SNO");
DelMar presented data demonstrating that VAL-083 overcomes cisplatin-resistance in ovarian cancer cell lines with known p53 mutations and displays synergy with both cisplatin and AstraZeneca’s PARP inhibitor Olaparib against ovarian cancer in vitro at the 11th Biennial Ovarian Cancer Research Symposium;
DelMar presented new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s ("AACR") annual meeting and at the IASLC 17th World Congress on Lung Cancer; and
DelMar presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors at the AACR (Free AACR Whitepaper) – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship Conference.
DelMar continued to strengthen its intellectual property portfolio around VAL-083. The Company now holds seven issued US patents and eight issued patents outside of the US. DelMar’s patent filings encompass thirteen patent families in various stages of prosecution and over 100 patent filings globally.
"Our excitement about VAL-083 and its potential to extend survival for bevacizumab-failed GBM patients continues to grow as we take steps toward initiating our planned pivotal Phase 3 trial," said Mr. Bacha.
"The recent initiation of a new Phase 2 clinical trial in collaboration with MD Anderson for bevacizumab-naïve MGMT-unmethylated GBM patients, along with a planned trial in newly diagnosed MGMT-unmethylated GBM patients, represent significant steps toward positioning VAL-083 as the chemotherapy of choice for the approximately two-thirds of newly diagnosed GBM patients whose tumors express high levels of MGMT. MGMT is a DNA repair enzyme linked with resistance to currently available chemotherapies including temozolomide and nitrosoureas."
Mr. Bacha continued, "We are also very pleased with our escalating progress to establish VAL-083’s potential to address chemo-resistance across a range of cancer indications for patients whose tumors exhibit features that make their cancer resistant or unlikely to respond to currently available therapy. Our research demonstrates the potential of VAL-083 to address unmet medical needs in a range of tumor types including GBM, non-small cell lung cancer, ovarian cancer and other solid tumors."