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PRESS RELEASES ADVENTRX Pharmaceuticals' Drug CoFactor™ Granted U.S. Orphan Drug Status by the FDA for Pancreatic Cancer SAN DIEGO – October 5, 2004 – ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today that it received orphan drug status from the U.S. Food and Drug Administration (FDA) for its lead compound, CoFactorT, for the treatment of pancreatic cancer. Orphan drug designation provides ADVENTRX with tax incentives for clinical development of CoFactor for trials conducted in the U.S., and seven years of marketing exclusivity following drug approval. Orphan drug status is granted by the FDA's Office of Orphan Products Development and is eligible for products to treat diseases that affect fewer than 200,000 people in the U.S. ADVENTRX plans to file an Investigational New Drug (IND) application with the FDA in the fourth quarter of 2004 for clearance to begin a Phase II trial in the U.S. for pancreatic cancer. "We are quite pleased to have received orphan drug designation for CoFactor," commented Cellia Habita, M.D., Ph.D., Vice President of Clinical and Medical Affairs for ADVENTRX. "Evidence from previous Phase II clinical trials and recent preclinical studies show that CoFactor has promise as part of a treatment regimen for pancreatic cancer to improve time to disease progression and survival while reducing toxicity associated with current treatment regimens." "With a poor overall survival rate, there is an urgent need for better treatments for pancreatic cancer," added Joan M. Robbins, Ph.D., Chief Technical Officer for ADVENTRX. "Orphan drug designation provides added benefits to help us attain our clinical development objectives and hopefully demonstrate the utility of CoFactor in combination with 5-FU in Phase II trials for this indication." CoFactor (5,10-methylenetetrahydrofolate) is a form of folic acid which acts by enhancing the anti-tumor effects of 5-FU while reducing side effects compared to current therapies. Unlike leucovorin, the currently used adjunctive agent that has to be metabolized in the body to be effective, CoFactor bypasses this metabolic step to deliver the correct form of folate to cancer cells, thus allowing 5-FU to work more effectively. In previous Phase II trials in Europe, CoFactor given before IV administration of 5-FU resulted in beneficial tumor responses in pancreatic, colorectal, gastric and breast cancer patients. CoFactor is currently being tested in a Phase II clinical trial in the U.S. and Europe for metastatic colorectal cancer. About Pancreatic Cancer The American Cancer Society (ACS) estimates that in the U.S., 31,860 will be diagnosed with pancreatic cancer and 31,270 will die from pancreatic cancer in 2004. According to the ACS, only about 24% of patients with cancer of the pancreas live one year following diagnosis, and only about 4% will survive 5 years after diagnosis. Moreover, in people diagnosed with local disease, in which the cancer has not metastasized to other organs, the 5-year relative survival rate is still only 17%. About ADVENTRX ADVENTRX Pharmaceuticals Inc. is a biopharmaceutical research and development company whose business strategy is to commercialize leading edge medical research through licensing agreements with prominent universities and research institutions. The Company focuses on cancer and antiviral research to launch products that either extend the usefulness of current therapies or replace marginal therapies with new approaches to treatment. More information on ADVENTRX Pharmaceuticals and CoFactor, can be found by visiting the Company's website at www.adventrx.com. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the United States Food and Drug Administration. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof. Contact: Andrea Lynn Director, Marketing and Technical Support ADVENTRX Pharmaceuticals 858 552-0866 |
