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ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Date:8/19/2007

SAN DIEGO, Aug. 16 /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 the U.S. Food and Drug Administration (FDA) has granted fast track designation for ANX-510, or CoFactor(R) injection, which is currently being investigated in a pivotal Phase 3 study, with 5-fluorouracil (5-FU) and bevacizumab for the initial treatment of metastatic colorectal cancer. CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU.

"The FDA's fast track designation represents a significant step towards bringing CoFactor to market as rapidly as possible," stated Evan M. Levine, chief executive officer of ADVENTRX. "We look forward to working closely with the FDA to expedite the review and approval process for CoFactor."

The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track status enables a sponsor to have more frequent and timely communication and meetings with the FDA regarding product development plans and may also result in eligibility for priority review of New Drug Applications. Fast track designation does not apply to a product alone but a combination of a product and specific indication.

ADVENTRX is currently conducting a 1,200-patient, Phase 3 clinical study of CoFactor for the tre
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SOURCE ADVENTRX Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

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