ANX Mast Therapeutics, Inc.

Cooperative Research and Development Agreement Establishes Framework for Participation of VA Hospitals and Clinics in Phase 3 Study of ANX-510 (CoFactor) SAN DIEGO, May 24 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX), a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, today announced that it has finalized a Clinical Trial Cooperative Research and Development Agreement (CRADA) under which U.S. Department of Veterans Affairs (VA) clinical sites may participate in the Company's Phase 3 clinical trial of ANX-510 (CoFactor) for the treatment of metastatic colorectal cancer. To date, under this arrangement, the Company has executed clinical trial agreements with three regional VA centers. "The participation of the VA and its broad network of hospitals and clinics expands our ability to reach patients with metastatic colorectal cancer and should accelerate enrollment in our Phase 3 clinical trial of CoFactor," said Evan M. Levine, chief executive officer of ADVENTRX. "Over the next several months, we expect to enter into agreements with additional VA sites and look forward to advancing our CoFactor Phase 3 clinical trial." About the Phase 3 Clinical Trial of ANX-510 (CoFactor) ADVENTRX is conducting a Phase 3 clinical study of ANX-510 for the treatment of metastatic colorectal cancer. This 1,200 patient, randomized clinical trial is being conducted in as many as 100 sites across the U.S. and in additional sites overseas. Patients are randomized to two arms containing either CoFactor or leucovorin, each in combination with the widely used cancer chemotherapy agent 5-fluorouracil (5-FU) and bevacizumab (Avastin(R)). The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events. The protocol and planned analysis were accepted by the FDA under a Special Protocol Assessment. About ANX-510 (CoFactor) ANX-510 is a folate-based biomodulator drug designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapy 5-fluorouracil (5-FU). In comparison to leucovorin, ANX-510 creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS). ANX-510 bypasses the metabolic pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. ANX-510 is in Phase 3 and Phase 2b clinical trials for the treatment of metastatic colorectal cancer, as well as in a Phase 2 clinical trial for the treatment of advanced breast cancer. About ADVENTRX Pharmaceuticals ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems such as drug metabolism, bioavailability, excessive toxicity and treatment resistance. More information can be found on the Company's web site at http://www.adventrx.com/. Forward Looking Statement ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones, including those associated with the development of CoFactor; the ability to timely enroll subjects in ADVENTRX's current and anticipated clinical trials; the timing and success of clinical trials, including its Phase 3 clinical trial of CoFactor; adverse side effects or inadequate therapeutic efficacy of CoFactor; the risk that preclinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical and clinical data suggests or as otherwise anticipated; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; the potential for CoFactor to receive regulatory approval for one or more indications on a timely basis or at all, and the uncertain process of seeking regulatory approval; other difficulties or delays in developing, testing, manufacturing and marketing of CoFactor; the scope and validity of patent protection for CoFactor; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at http://www.sec.gov/. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX assumes no obligation to revise or update any forward-looking statement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made. DATASOURCE: ADVENTRX Pharmaceuticals, Inc. CONTACT: Investors, Ioana C. Hone of ADVENTRX Pharmaceuticals, Inc., +1-858-552-0866; or Media, Edie DeVine of WeissComm Partners, +1-415-946-1081, for ADVENTRX Pharmaceuticals, Inc. Web site: http://www.adventrx.com/ Company News On-Call: http://www.prnewswire.com/comp/920134.html

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