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PRESS RELEASES First Patients Dosed with CoFactor™ in U.S. Phase II Clinical Trial for Metastatic Colorectal Cancer SAN DIEGO – May 4, 2004 – ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today that it has started dosing patients in a first line Phase II clinical trial to test CoFactor in metastatic colorectal cancer. CoFactor, a biomodulator of 5-fluorouracil (5-FU), one of the most widely used chemotherapeutic agents, will be evaluated in patients not previously treated or in those who have relapsed from previous 5-FU/leucovorin therapy. CoFactor qualifies for the FDA's Fast Track Program for rapid drug review for metastatic colorectal cancer. In addition to the VA San Diego Healthcare System, the trial is taking place at several other sites in the U.S, including Mercy General Hospital in Sacramento, California, where the first patients were dosed. "We are very pleased to begin testing of CoFactor in the U.S.," commented Cellia Habita, M.D., Ph.D., Vice President of Clinical and Medical Affairs for ADVENTRX Pharmaceuticals. "This is the first stage in our expansion of clinical testing of CoFactor for treatment of a variety of cancers, with an emphasis on lower toxicities and increased survival compared to current therapies. Later this quarter, we also intend to file for clearance to begin first-line metastatic colorectal cancer trials in the UK as part of our international strategy for regulatory approvals." CoFactor (5,10-methylenetetrahydrofolate) is a chemotherapy drug designed for use with 5-FU. CoFactor 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, which has to be metabolized in the body to be effective, CoFactor bypasses the biochemical pathway to deliver the correct form of folate to cancer cells allowing 5-FU to work more effectively. CoFactor was previously studied in Phase II trials in Europe which showed a 100 mg dose of CoFactor given 20 minutes before IV administration of the chemotherapy agent 5-FU was able to improve survival in metastatic colorectal cancer patients and showed very low toxicity. "Delivering folate in this form may allow 5-FU to work more efficiently to abate tumor growth. This appears to be the case from the data from previous European studies," remarked Tony Reid, M.D., Ph.D., the study's Principal Investigator of the VA San Diego Healthcare System. "We certainly hope similar results can be achieved here in the U.S." According to the American Cancer Society, colorectal cancer is the third most common cancer both in men and women and is the second leading cause of cancer death in the U.S. 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. 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: The Ruth Group Investors: Stephanie Carrington 646-536-7017 Media: Cynthia Isaac, Ph.D. 646-536-7028 |
