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ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
Date:10/10/2007

SAN DIEGO, Oct. 10 /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, announced today that it has completed patient enrollment in its marketing-enabling clinical study of ANX-530 (vinorelbine emulsion), a novel, emulsion formulation of vinorelbine tartrate. Vinorelbine tartrate, marketed under the brand name Navelbine(R), is an anti-cancer agent that is approved to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin. Worldwide annual sales of Navelbine and generic vinorelbine in 2006 were approximately $200 million.

"Completing enrollment keeps us on schedule to announce results from this study next month and, if the results are succesful, to submit an NDA as early as next year," said Evan M. Levine, chief executive officer of ADVENTRX. "Advancing ANX-530 is a key value-driver for this company and we are taking the steps to help ensure its success. We are preparing for a meeting with the FDA later this year and plan to provide an update regarding our NDA timeline for ANX-530 following that meeting."

ANX-530 is currently being tested in a 28-patient bioequivalence study. The study is a crossover comparison of ANX-530 and Navelbine, also available as generic vinorelbine, with a primary endpoint of pharmacokinetic equivalence of ANX-530 and Navelbine. The safety of a single dose of ANX-530 is being evaluated as a secondary endpoint. The FDA has indicated that this single clinical study, should it demonstrate bioequivalence between ANX-530 and Navelbine, would provide sufficient clinical dat
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