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PRESS RELEASES ADVENTRX Pharmaceuticals Initiates European Sites for its CoFactor Phase II Clinical Study SAN DIEGO – July 7, 2004 – ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today that it has initiated patient recruitment in European sites as an extension of its CoFactor first line Phase II clinical trial in metastatic colorectal cancer, already underway at four sites in the US. Patients have already been enrolled in the CoFactor trial at these European sites. "The additional sites will help us reach enrollment objectives more quickly and allow us to establish a network of clinical sites in Europe in anticipation of launching other CoFactor trials later this year," commented Cellia Habita, M.D., Ph.D., Vice President for Clinical and Medical Affairs for ADVENTRX. "These additional trials will include treatment of patients with advanced pancreatic cancer, with the intent to duplicate the results in previous Phase I/II trials, where the majority of pancreatic cancer patients lived longer than one year during treatment with CoFactor and 5-FU." The Phase II trial is an open label, single arm study to assess CoFactor in patients with metastatic colorectal cancer not previously treated or in those who have relapsed from previous 5-FU/leucovorin therapy. CoFactor (5,10-methylenetetrahydrofolate) is a biomodulator of 5-fluorouracil (5-FU), one of the most commonly used chemotherapeutic agents. CoFactor is a form of folic acid that acts by enhancing the anti-tumor effects of 5-FU while reducing side effects compared to current therapies. In a previous Phase I/II clinical trial in Europe, use of CoFactor in combination with 5-FU in a variety of tumor types demonstrated the following rates of clinical benefit, defined as stable disease or tumor response: pancreatic (40%), colorectal (57%), gastric (66%) and breast (89%). 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 |
