VANCOUVER, BC and MENLO PARK, CA--(Marketwired - July 02, 2013) - DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar Pharma") today announced that the company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application No. 13/817,046, entitled, "Method of Synthesis of Substituted Hexitols such as Dianhydrogalactitol." The patent covers methods for synthesizing VAL-083, which is DelMar Pharma's lead drug candidate currently in a Phase I/II clinical trial in the United States (U.S.) for the treatment of glioblastoma multiforme (GBM).
Jeffrey Bacha, President & CEO of DelMar Pharma, said, "Since we founded the company in 2010, we have been building a broad patent portfolio around our lead drug candidate, VAL-083, for global use and to treat a number of different cancers. In pre-clinical and clinical studies by the U.S. National Cancer Institute, VAL-083 has been shown to be safe and effective in fighting a range of tumor types, including glioblastoma multiforme, the most common and aggressive form of brain cancer. We are excited to receive this patent as we take another step in our strategic and clinical development efforts to bring VAL-083 to cancer patients who need better treatment options."
DelMar Pharma's patent applications claim compositions and methods related to the use of VAL-083 and related compounds as well as methods of synthesis and quality controls for the manufacturing process of VAL-083. In addition, VAL-083 has been granted protection under the Orphan Drug Act by the U.S. Food and Drug Administration (FDA) and by the European Committee for Orphan Medical Products.
VAL-083 represents a 'first-in-class' small-molecule chemotherapeutic. VAL-083 has been assessed in multiple NCI-sponsored clinical studies in various cancers including lung, brain, cervical, ovarian tumors and leukemia. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types, including GBM the most common and aggressive form of brain cancer. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer.
DelMar Pharma is currently conducting a Phase I/II clinical trial in the U.S. to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of VAL-083 in patients with recurrent GBM. Patients eligible for the DelMar Pharma GBM clinical trial have been previously treated with surgery and/or radiation, if appropriate, and must have failed both Avastin and Temodar, unless either or both are contra-indicated.
In June 2013, DelMar presented interim clinical data at the American Society of Clinical Oncology (ASCO) meeting indicating that, at doses tested to date, VAL-083 is safe and well tolerated and a proportion of GBM and secondary-progressive brain cancer patients having failed prior therapy show stable disease or tumor regression in response to VAL-083 treatment even at doses well below those used in historical clinical studies.
Please refer to clinicaltrials.gov identifier NCT01478178 for further details on this clinical trial or visit http://www.clinicaltrials.gov/ct2/show/NCT01478178?term=VAL--083&rank=1
About DelMar Pharma
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 refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. VAL-083 benefits from extensive clinical research sponsored by the US 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.
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.
For further information, please visit www.delmarpharma.com.