ADVENTRX (ANX) Discusses ANX-188 Phase 3 Structure w/ FDA; Additional Info Needed for Finalization
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ADVENTRX Pharmaceuticals, Inc. (AMEX: ANX) reports 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.
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.
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