ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of C...(dging study we expect to assessour optio...),Health

Date:7/1/2008

dging study, we expect to assess our options for continued development of CoFactor, including potentially reinitiating discussions with regulatory authorities," stated Evan M. Levine, Chief Executive Officer and President of ADVENTRX. "Given our encouraging progress with ANX-530 and ANX-514, our resources are focused primarily on advancing our later-stage product candidates, which includes submitting an NDA for ANX-530 and completing our registrational bioequivalence clinical study for ANX-514," added Mr. Levine.

About the Discontinued Phase 3 Clinical Study

The Phase 3 clinical trial was a randomized, controlled, multicenter study designed to evaluate the safety and efficacy of CoFactor/5-FU/Avastin and leucovorin/5-FU/Avastin in patients with first-line metastatic colorectal cancer. Eighty-nine patients were randomized to either the leucovorin control arm or the CoFactor experimental arm, with a bolus regimen of 5-FU (the Roswell Park regimen) and Avastin; eighty-five patients were treated. The primary endpoint in this study was an improvement in progression-free survival. Secondary endpoints included response rate, overall survival and incidence and severity of adverse events.

About ANX-510, or CoFactor

CoFactor is a folate-based biomodulator designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil. Compared to leucovorin, CoFactor creates more stable binding between the active form of 5-FU and the target enzyme, thymidylate synthase. CoFactor bypasses the metabolic pathway required by leucovorin to deliver the active form of folate, potentially allowing 5-FU to work more effectively.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates primarily for the treatment of cancer and infectious
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SOURCE ADVENTRX Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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