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PRESS RELEASES ADVENTRX Presents Response Data for Total Enrollment in CoFactor Phase II Metastatic Colorectal Cancer Trial Poster Presented at 7th World Congress on Gastrointestinal Cancer San Diego June 20, 2005 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced response data from all 48 measurable patients in its 50-patient Phase II trial with CoFactor and 5-fluorouracil (5-FU) as a first-line treatment for metastatic colorectal cancer. CoFactor is ADVENTRX's biomodulator designed to enhance the effects of the widely used cancer drug, 5-FU. A poster of these results was presented at the 7th World Congress on Gastrointestinal Cancer in Barcelona, Spain. Updated Phase II COFU trial data
Cellia Habita, M.D., Ph.D., senior vice president of medical and clinical affairs of ADVENTRX, presented poster # 371 entitled, "A Simon two stage study of CoFactor (CO) with 5-fluorouracil (FU) as first line treatment in metastatic colorectal cancer (mCRC)." This abstract is available via ADVENTRX's Web site at www.adventrx.com. About CoFactor CoFactor (ANX-510) is a folate-based biomodulator drug developed to enhance the activity of the widely used cancer chemotherapeutic 5-FU. Data from previous clinical trials in Europe have demonstrated clinical benefit and improved overall median survival in patients with advanced tumors, including colorectal, pancreatic and breast. In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU, FdUMP, to the target enzyme, thymidylate synthase (TS). CoFactor bypasses the chemical pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. This improves 5-FU performance and lowers toxicity. More information on CoFactor can be found at http://www.adventrx.com/products/antic_cofactor.htm. About the Phase II COFU trial The Phase II clinical trial is an open label, single arm Simon 2 stage study design to assess the safety and efficacy of CoFactor plus 5-FU as a first line treatment of metastatic colorectal cancer. Patients enrolled in this trial are age 18 and older with ECOG 0-2 and measurable metastatic colorectal cancer, with or without adjuvant 5-FU/leucovorin, irinotecan, or oxaliplatin, but no prior chemotherapy for metastatic disease. Patients may receive more than two cycles each consisting of CoFactor 60 mg/m2 and 5-FU 450 mg/m2 (weekly IV bolus) for six consecutive weeks, followed by a 14 day rest period, which is defined as a cycle. Pre-established response criteria are greater than four responders of 23 patients for stage one, and greater than 12 responders of 48 patients for the full trial. The trial is being conducted in the U.S. and Europe under a U.S. investigational new drug application. About ADVENTRX ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability or resistance. More information can be found on the Company's Web site at www.adventrx.com. Forward Looking Statement 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 FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's last quarterly report on Form 10-Q, as well as other reports that the Company files from time to time with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.
Contact:
ADVENTRX Pharmaceuticals Andrea Lynn 858-552-0866
Investor Contact:
Lippert Heilshorn & Associates Jody Cain (jcain@lhai.com) Brandi Floberg (bfloberg@lhai.com) 310-691-7100 |