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ADVENTRX Pharmaceuticals Provides Update on ANX-514
Date:2/15/2011

SAN DIEGO, Feb. 15, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today provided an update on its product candidate, ANX-514, its polysorbate 80-free formulation of docetaxel.  The U.S. Food and Drug Administration (FDA) determined that ANX-514 could not be approved based on the findings from the bioequivalence study of ANX-514 (Study 514-01) and that additional development activities would be required for approval.  ADVENTRX met with the FDA to discuss required activities.  

"We are pleased with the outcome of our discussion with FDA, at which the conceptual design of a single, additional clinical study that could support approval of ANX-514 was discussed.  We believe the study requested by the Agency is reasonable, and we are developing a study protocol for submission to the FDA.  We will provide a further update after receiving feedback from FDA on the protocol," said Brian M. Culley, Chief Executive Officer of ADVENTRX.  

"We have netted over $50 million from financings during the last 18 months and we intend to use this capital to continue to develop ANX-514, to pursue acquisition opportunities, such as our recently-announced agreement to acquire SynthRx, and to prepare for the commercial launch of Exelbine™, should it be approved," Mr. Culley continued.  

ADVENTRX met with the FDA to discuss ANX-514.  Prior to the meeting, ADVENTRX submitted to the FDA a data package based on Study 514-01 and published literature.  ADVENTRX believes the data package supports the conclusion that comparable clinical outcomes can be expected following treatment with either ANX-514 or Taxotere®, despite Study 514-01 not demonstrating bioequivalence, its primary endpoint, using an unscaled bioequivalence methodology.  In particular, the data package concludes that unbound docetaxel concentrations
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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