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SOURCE DelMar Pharmaceuticals, Inc.
VANCOUVER, British Columbia and MENLO PARK, Calif., July 9, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar") announced today that the company has been awarded a non-refundable financial contribution of up to CDN$194,000 from the National Research Council of Canada's Industrial Research Assistance Program (NRC-IRAP).
The research funded by this award will be conducted in collaboration with the University of British Columbia, the Vancouver Prostate Centre and the B.C. Cancer Agency. This funding represents the fourth contribution that DelMar has received from NRC-IRAP, bringing the total to CDN$327,000 in financial support to date.
"We are pleased to receive advisory services and technological expertise along with funding support from NRC-IRAP and appreciate Canada's ongoing commitment to support growing companies like DelMar Pharmaceuticals," said Jeffrey Bacha, president & CEO. "This funding will support personnel and research costs and enable us to accelerate and broaden non-clinical research aimed at further establishing the competitive differentiation of our lead product candidate, VAL-083, as a potential chemotherapy for the treatment of glioblastoma multiforme and non-small cell lung cancer."
VAL-083 represents a first-in-class, small-molecule chemotherapeutic with a unique mechanism of action. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute (NCI), VAL-083 demonstrated promising activity against 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 United States for the treatment of gliomas.
VAL-083 in Glioblastoma Multiforme (GBM)
Glioblastoma multiforme (GBM) is the most common and most malignant form of brain cancer. Approximately 15,000 people are diagnosed with glioblastoma each year in the United States, with similar incidence in Europe. Standard of care is surgery, followed by radiation therapy or combined radiation therapy and chemotherapy with temozolomide.
GBM has a poor prognosis and only modest improvements in therapy have been made over the past 25 years. Median survival for newly diagnosed patients is less than two years and approximately 60 percent of GBM patients treated with the standard front-line temozolomide regimen experience tumor progression within one year. Patients who fail the currently approved therapies have limited treatment options and a very poor prognosis, with a median survival of three to six months.
DelMar has presented in vitro data demonstrating that VAL-083's unique mechanism of action is unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to temozolomide (Temodar®), the current standard front-line therapy for the treatment of GBM. DelMar believes that these data, in conjunction with VAL-083's historical activity, establish the drug's potential to provide a viable treatment option for patients suffering from refractory and newly-diagnosed GBM.
DelMar is currently conducting an open-label, single arm dose-escalation Phase I/II human clinical trial in the United States designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of VAL-083 in patients with recurrent GBM. Interim data from this trial was recently presented at the 50th Annual Meeting of the American Society for Clinical Oncology (ASCO). The clinical trial is currently enrolling at three clinical sites in the United States: The University of California, San Francisco (UCSF), The Sarah Cannon Research Institute (SCRI) in Nashville, Tenn., and the SCRI affiliate site at the Florida Cancer Specialists in Sarasota, Fla. Further information regarding DelMar's clinical trial can be found at http://www.clinicaltrials.gov/ct2/show/NCT01478178?term=val-083&rank=1
VAL-083 in Non-Small Cell Lung Cancer (NSCLC)
The treatment of non-small cell lung cancer (NSCLC) remains an unmet medical need. About 85 percent to 90 percent of lung cancers are NSCLC, represented by three sub-types: squamous cell carcinoma, adenocarcinoma and large cell carcinoma.
The median overall survival time for patients with stage IV (NSCLC) is four months, and one- and five-year survival is less than 16 percent and 2 percent, respectively. Standard of care for NSCLC is surgery followed by treatment with either tyrosine kinase Inhibitors (TKIs), such as Tarceva®, or platinum-based regimens. TKIs have resulted in vastly improved outcomes for many patients; however, TKI resistance has emerged as a significant unmet medical need, and long-term prognosis with platinum-based therapies remains poor. Additionally, the incidence of NSCLC spreading to the brain is high with very poor prognosis.
VAL-083 is currently approved as a chemotherapy for the treatment of lung cancer in the People's Republic of China but not widely used. DelMar has presented data demonstrating that, in an established murine xenograft model of NSCLC, the activity of VAL-083 was compared to standard platinum-based therapy with cisplatin against human NSCLC cell lines A549 (TKI-sensitive) and H1975 (TKI-resistant). In the study, VAL-083 demonstrated superior efficacy and safety in the treatment of TKI-susceptible (A549) tumors and in TKI-resistant (H1975) tumors. DelMar believes that these data support the use of VAL-083 to address unmet medical needs in the treatment of NSCLC. Based on these data, DelMar plans to conduct post-market (Phase IV) clinical studies in collaboration with its manufacturing partner, Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd., to support product repositioning and sales growth in China. Favorable data from these studies would also support the potential expansion of DelMar's development and commercialization activities on a global basis.
About DelMar Pharmaceuticals
DelMar Pharmaceuticals was founded in 2010 to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments. The Company's lead asset, VAL-083, is currently undergoing clinical trials in the United States as a potential treatment for recurrent glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. VAL-083 benefits from extensive clinical research sponsored by the U.S. National Cancer Institute (NCI), 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. DelMar's scientific presentations can be viewed on the company's website at www.delmarpharma.com.
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. We do not undertake to update these forward-looking statements made by us.
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