Ampion: Phase III ongoing

Ampio said it will report data later than previously expected from the double-blind, placebo-controlled, U.S. Phase III STEP trial evaluating a single 4 mL intra-articular injection of Ampion in 500 patients. Top-line data from the trial were originally expected this quarter, with a BLA submission slated for 1Q15. Ampio attributed the delay to the discovery by an independent CRO that Ampion and placebo were exposed to “lower temperatures than permitted by the drug specifications” during shipment to trial sites. ...