Highlights Commercial and Development Opportunities for VAL-083
VANCOUVER, British Columbia, Nov. 8, 2012 /PRNewswire/ -- Del Mar Pharmaceuticals (BC) Ltd. (DelMar) today announced that Mr. Jeffrey Bacha, the Company's President & CEO, delivered the keynote address entitled VAL-083 a Novel Chemotherapeutic Agent Developed in China for CML and Lung Cancer Shows Potential to Surpass Standard of Care in Glioblastoma Multiforme at the 2012 International Drug Discovery Science and Technology Conference in Nanjing, China.
In his address, Mr. Bacha highlighted DelMar's ongoing Phase I/II clinical trial with VAL-083 as a potential new therapy for patients suffering from glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
The trial, which is being conducted under an investigational new drug application (IND), in the United States is designed to evaluate the safety, tolerability and anti-tumor activity of VAL-083 in GBM patients who have failed front line therapy with Temodar™ and second-line therapy with Avastin™. According to published data, approximately half of patients diagnosed with GBM will fail both front and second line therapy. Currently, there are no approved treatments for these patients.
"DelMar has developed new data to re-position the dosing regimen for GBM in the context of modern care," stated Mr. Bacha in his address. "We believe that this approach will provide benefit to patients who currently have very limited treatment options."
VAL-083, known as "DAG for Injection" in China, represents a first-in-class bi-functional alkylating agent. The drug benefits from prior extensive clinical research sponsored by the United States National Cancer Institute (NCI), and is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer. Previous pre-clinical and clinical studies sponsored by the NCI suggest that VAL-083 may have activity against a range of tumor types, including GBM. DelMar previously presented data at the 2011 American Association of Cancer Research (AACR) demonstrating that the unique mechanism of VAL-083 maintained activity in against GBM cell lines that were resistant to other therapies due to high expression of the O6 methylguanine methyltransferase (MGMT) repair enzyme.
During his keynote address, Mr. Bacha also presented initial data demonstrating that VAL-083 also maintains activity against other resistance mechanisms prevalent in other types of cancer.
DelMar recently announced a collaboration with China-based Guangxi Wuzhou Pharmaceuticals. Guangxi Wuzhou Pharmaceuticals is the only manufacturer licensed by SFDA to produce and sell VAL-083 for the treatment of CML and lung cancer in China. The Collaboration provides DelMar with exclusive commercial and development rights to VAL-083 on a worldwide basis.
"This landmark collaboration positions DelMar to benefit patients in China immediately," stated Mr. Bacha. "Our initial data with VAL-083 demonstrating activity against tyrosine kinase inhibitor (TKI) resistant tumors provides physicians in China with a new way to treat patients who exhibit resistance to leading TKI therapies in CML and lung cancer, which remains a growing and significant unmet medical need."
Recent scientific publications have highlighted the greater level of resistance to TKIs in patients of East Asian descent compared with patients in the United States and Europe.
Mr. Bacha noted that DelMar plans to work closely with Guangxi Wuzhou Pharmaceuticals and leading oncologists in China to continue to develop data supporting the expanded commercialization of VAL-083 in the currently approved indications of CML and lung cancer for patients resistant to front-line TKI therapy, and also to seek to expand the current SFDA approval to include other cancers, including GBM. "These data will also be useful in supporting the development and commercialization of VAL-083 on a world-wide basis," he said.
About DelMar Pharma
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 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.
For further information, please visit www.delmarpharma.com
or contact Jeffrey A. Bacha, President & CEO (604) 629-5989
SOURCE Del Mar Pharmaceuticals