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PRESS RELEASES CoFactor™ Granted Orphan Drug Status in the European Union for Pancreatic Cancer SAN DIEGO – October 14, 2004 – ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today that its lead compound, CoFactorT, received orphan drug designation from the European Medicines Evaluation Agency (EMEA) for the treatment of pancreatic cancer. Orphan medicines are drugs for treating life threatening medical conditions that affect fewer than 5 out of every 10,000 people in the European Union (EU). EU orphan status provides incentives, such as reduced fees for protocol assistance and scientific advice, and increased time for market exclusivity following drug approval. This announcement follows recent news acknowledging CoFactor orphan status in the U.S. ADVENTRX plans to submit a Clinical Trial Application (CTA) in the first quarter of 2005 in the EU in order to conduct Phase II pancreatic cancer trials there. Active preparations in anticipation of trials in pancreatic cancer patients in the EU are ongoing. "We are quite happy to have received orphan drug designation for CoFactor in the EU in addition to the US," commented Cellia Habita, M.D., Ph.D., Vice President of Clinical and Medical Affairs for ADVENTRX. "We plan to use the incentives available through this Orphan Drug Program and we are seeking protocol assistance from the EMEA. We plan to proceed with the pancreatic clinical trial in the EU as soon as allowance is granted." About Pancreatic Cancer According to the International Agency for Research on Cancer (IARC), pancreatic cancer affects about 13,000 people per year in the EU. The survival rates are very poor. Less than 5% of those with pancreatic cancer survive after five-years. 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 |
