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Biotech / Medical : ADVENTRX Pharmaceuticals Inc (Anx) -- Ignore unavailable to you. Want to Upgrade?

To: Keith Feral who wrote (113)	5/24/2007 1:08:05 PM
From: estatemakr	Respond to of 418

ADVENTRX Executes Agreement With United States Department of Veterans Affairs Thursday May 24, 9:30 am ET 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 - News), 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®). 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.