ADVENTRX, FDA discuss ANX-188 development plans for treatment of sickle cell crisis

Dec 1 2011

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it met with the U.S. Food and Drug Administration (FDA) to review development plans for ANX-188 (purified poloxamer 188), the Company's first-in-class treatment for sickle cell patients experiencing vaso-occlusive crisis. 

ADVENTRX and the FDA discussed a variety of topics related to the overall development of ANX-188, as well as the design of a phase 3 study for the treatment of sickle cell patients experiencing vaso-occlusive crisis.  While an understanding regarding certain matters was reached, additional interaction over the next several weeks and months is needed to finalize ANX-188 development plans.  During that time the Company will continue to make progress on the manufacture of clinical trial material so that a phase 3 study can be initiated in 2012.

Brian M. Culley, Chief Executive Officer of ADVENTRX, said, "As part of our commitment to a strong relationship with FDA, we have met with the Agency four times in recent months to discuss development plans for our product candidates. In particular, with a complex condition such as sickle cell crisis, it is crucial to have clarity around all aspects of our development plans for ANX-188. We appreciate FDA's continued involvement and look forward to further dialogue with the Agency, which will allow us to reach agreement on a path to approval for ANX-188 for the benefit of sickle cell patients."