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PRESS RELEASES ADVENTRX Pharmaceuticals Announces CoFactor™ Results Showing Antitumor Activity with Lower Systemic Toxicity in a Colorectal Cancer Model SAN DIEGO October 1, 2004 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced the results of recent preclinical studies demonstrating enhanced antitumor activity with lower systemic toxicity in a mouse model for colorectal cancer using CoFactor™, as compared to leucovorin, in combination with the chemotherapeutic agent 5-fluorouracil (5-FU). These results suggest replacing leucovorin, the currently used adjunctive agent, with CoFactor in humans could reduce the side effects associated with using 5-FU while simultaneously improving 5-FU's antitumor activity. Results were presented at the 16th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics conference in Geneva Switzerland on October 1. "These data are very encouraging when you consider that many cancer patients do not receive the full recommended course of chemotherapy because they cannot tolerate the toxicity associated with their cancer treatment," said Dr. Joan M. Robbins, Chief Technical Officer for ADVENTRX Pharmaceuticals and coauthor on the study. "These results suggest CoFactor may be able to reduce the toxicity in patients being treated with 5-FU." CoFactor is currently being tested in a Phase II clinical trial in the US and Europe under a US IND for metastatic colorectal cancer. CoFactor is a biomodulator of 5-FU, and is designed to allow 5-FU to work more effectively to kill cancer cells. 5-FU is the standard treatment for numerous cancer types, including colorectal cancer. Despite its antitumor activity, 5-FU can cause dose-limiting side effects, including decreased white blood cell and platelet counts. CoFactor's antitumor activity in combination with 5-FU has previously been demonstrated in phase I/II clinical trials in Europe. CoFactor Preclinical Study Overview: Using an in vivo mouse toxicity model, results showed treatment with either 5-FU alone or combination 5-FU/leucovorin caused 100% mortality within 12 days of treatment initiation. In contrast, 38% of the mice treated with CoFactor/5-FU (p < 0.05, Logrank test) survived significantly beyond this time. Blood analysis revealed significantly more white blood cells in 5-FU/CoFactor treated mice than 5-FU/leucovorin treated mice (p < 0.05, Student's t test). Specifically, significantly more platelets and neutrophils in the 5-FU/CoFactor treated group were observed. Despite the lower systemic toxicity profile, the CoFactor/5-FU combination still maintained its antitumor activity. 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 |