Today, ADVENTRX Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing proprietary product candidates, announced that it met with the U.S. Food and Drug Administration (FDA) to review development plans for ANX-188 (purified poloxamer 188). ANX-188 is the company’s first-in-class treatment for sickle cell patients who experience vaso-occlusive crisis.
At the meeting, ADVENTRX and the FDA discussed topics related to the overall development of ANX-188, in addition to discussions regarding the design of a phase 3 study for the treatment of sickle cell patients experiencing vaso-occlusive crisis.
Brian M. Culley, Chief Executive Officer of ADVENTRX, remarked, “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.”
While ADVENTRX and the FDA reached an understanding regarding certain matters, the entities will communicate over the next several weeks and months to finalize development plans for ANX-188. During that time, the company will continue to make progress on the manufacture of clinical trial material for a phase 3 study to occur sometime in 2012.
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