DelMar Pharmaceuticals and Guangxi Wuzhou Pharmaceuticals Establish Clinical Advisory Board in China
Advisory Board to Oversee Clinical Studies in China to Support Product Growth and Repositioning of VAL-083
VANCOUVER, British Columbia, MENLO PARK, Calif., and WUZHOU, China, Sept. 9, 2013 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar") and Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd., a subsidiary of Guagxi Wuzhou Zhongeng Group Co., Ltd. (SHG 600252) today announced that the companies have established a clinical advisory board to oversee new clinical studies aimed at expanding the market opportunity for VAL-083, known as "DAG for Injection" in China.
DelMar and Guangxi Wuzhou Pharmaceutical established a collaboration and exclusive supply agreement in 2012. Under the terms of the collaboration, the companies are working together to ensure the product specifications meet global standards in order to accelerate international development and regulatory approval for VAL-083 on a worldwide basis.
"Guangxi Wuzhou Pharmaceuticals is pleased to be working through the collaboration with DelMar to get VAL-083 approved by FDA and to create a foundation for sales in international markets to maximize the value of Wuzhou Pharmaceutical's business in China. This will result in meaningful sales growth in China and international markets for the product," stated Chen Ming, vice chairman of Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.
Jeffrey Bacha, president & CEO of DelMar added, "Establishing a network of key opinion leaders in China is an important step in our goal to make VAL-083 available as a valuable therapy for cancer patients with limited treatment options in China and on a global basis. Based on published literature and our own research into the mechanism of VAL-083, we believe that the drug has potential utility in a range of cancer indications. We are very pleased to be working with Guangxi Wuzhou Pharmaceutical and this distinguished advisory board toward the successful implementation of our development and commercialization goals."
VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer. DelMar is currently conducting a Phase I/II dose-escalation study in the U.S. designed to assess the safety and efficacy of VAL-083 as a potential treatment for patients suffering from refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, who have failed standard therapies and have no viable treatment options.
DelMar and Guangxi Wuzhou Pharmaceutical have nominated leading physicians as an initial advisory board to provide oversight and design of clinical trials to be conducted in accordance with the terms of the collaboration agreement. The advisory board in China is comprised of:
- Clinical Advisors for CML:
- Professor Li Junmin Professor of Medicine, Shanghai Ruijin Hospital, Shanghai Jiao Tong University
- Professor Xiao Zhi-Jian Professor of Medicine, Blood Disease Hospital, Blood Research Institute, Chinese Academy of Science
- Clinical Advisor for Lung Cancer:
- Professor Lu Shun Professor of Medicine, Shanghai Jiao Tong University, Shanghai Lung Cancer Center
- Clinical Advisor for Brain Cancer:
- Professor Chen Zhong-Ping of Sun Yat-Sen University, Chairman, Chinese Society for NeuroOncology
- CFDA Regulatory Advisor:
- Dr. Dan Zhang, chairman of Fountain Medical Inc, and member of the Chinese Food and Drug Administration Oncology Advisory Panel
Members of the advisory board will provide input into new VAL-083 clinical studies to be conducted in China to support product positioning in approved indications and the development of VAL-083 in new indications, such as GBM for patients who are unlikely to respond to front-line Temodar® therapy, which could vastly expand the market opportunity for the drug.
New clinical research in China will be supported by clinical and non-clinical research being conducted by DelMar in collaboration with leading academic institutions in North America, Europe and Asia. The new members of the advisory board will also liaise with members of DelMar's existing clinical advisory board, which will benefit the development of VAL-083 by ensuring that new clinical data developed will be valuable to support regulatory and drug development activities on a global basis.
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. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer.
Based on published research, the mechanism of action of VAL-083 is understood to be a bi-functional alkylating agent; however, the functional groups associated with alkylating events has been shown to differ from other alkylating agents used in the treatment of GBM.
VAL-083 has previously demonstrated activity in cyclophosphamide, BCNU and phenylanine mustard resistant cell lines and no evidence of cross-resistance has been encountered in published clinical studies. Based on the presumed alkylating functionality of VAL-083, published literature suggests that DNA repair mechanisms associated with Temodar and nitrosourea resistance, such as O6-methylguanine methyltransferase (MGMT), may not confer resistance to VAL-083.
VAL-083 readily crosses the blood brain barrier where it maintains a long half-life compared to plasma. Published preclinical and clinical research demonstrates that VAL-083 is selective for brain tumor tissue.
VAL-083 has been assessed in multiple studies as a chemotherapy in the treatment of newly diagnosed and recurrent brain tumors. In general, tumor regression was achieved following therapy in greater than 40 percent of patients treated and stabilization was achieved in an additional 20 to 30 percent. In published clinical studies, VAL-083 has previously been shown to have a statistically significant impact on median survival in high-grade gliomas when combined with radiation versus radiation alone.
The main dose-limiting toxicity related to the administration of VAL-083 in previous clinical studies was myelosuppression. No significant hepatic, renal or pulmonary toxicity has been reported.
About Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd. and Zhongheng Group Co. Ltd.
Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd., a wholly owned subsidiary of Zhongheng Group Co., Ltd. (SHG 600252) is principally engaged in the manufacture of pharmaceuticals. The Company's main products include cardiovascular drugs, medicine for bruises, and gynecology medication, among others. Zhongheng Group is also involved in the investment and management of infrastructure, urban utility facilities and logistics services; asset operation and management, as well as domestic commercial trading. The Company operates its businesses primarily in Wuzhou, Guangxi autonomous region, China. Further information is available on the company's website: http://www.wz-zhongheng.com/
About DelMar Pharmaceuticals
Del Mar 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 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.
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 informationabout DelMar Pharmaceuticals, please visit www.delmarpharma.com; or contact Jeffrey Bacha, President & CEO (604) 629-5989 or Booke & Company Investor Relations, firstname.lastname@example.org
SOURCE DelMar Pharmaceuticals
Released September 9, 2013