ADVENTRX Pharmaceuticals met with the 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 III 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 III study can be initiated in 2012.