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ADVENTRX Announces ANX-514 Clinical Development Plan Affirmed by the FDA
Date:9/10/2007

SAN DIEGO, Sept. 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 received confirmation from the U.S. Food and Drug Administration (FDA) regarding its proposed 505(b)(2) New Drug Application (NDA) regulatory path for ANX-514 (docetaxel emulsion). The FDA has indicated that data from a single study of approximately 28 patients that demonstrates the bioequivalence of ANX-514 and docetaxel is sufficient to support filing an NDA. Docetaxel is an anti-cancer agent that is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers, and is marketed under the brand name Taxotere(R). Annual sales of Taxotere in 2006 were approximately $2.2 billion.

"This guidance from the FDA is significant as conducting a single marketing-enabling trial provides us a clear and direct clinical path and substantially shortens the timelines for clinical development and submitting an NDA for ANX-514," said Evan M. Levine, chief executive officer of ADVENTRX. "Pending appropriate clearances, we look forward to starting the proposed bioequivalence trial later this year."

The Company currently plans to submit an investigational new drug (IND) application in the fourth quarter of 2007. The proposed clinical trial will compare the blood levels of docetaxel following a single dose of ANX-514 or Taxotere in patients with advanced cancers. In addition, the Company plans to analyze the safety of ANX-514.

ANX-514 Preclinical Results

Preclinical results have demonstrated equivalent pharmacoki
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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