Ixmyelocel-T: Phase III discontinued

Aastrom said it will no longer develop its only product, ixmyelocel-T, to treat CLI and will instead focus R&D resources on developing the product for dilated cardiomyopathy (DCM). The company terminated the double-blind, placebo-controlled, U.S. Phase III REVIVE trial evaluating intramuscular ixmyelocel-T to treat CLI based on "enrollment challenges" and the determination that the program would "not be supported by a partner in a timeframe that would impact the pace of enrollment of the study." The company said that DCM and other rare diseases may require smaller studies, with a lower cost and shorter path to approval. REVIVE had enrolled 40 of a planned 594 patients as of March 18. Late last year, Aastrom began enrollment in the double-blind, placebo-controlled, U.S. Phase IIb ixCELL-DCM trial to evaluate intramyocardial ixmyelocel-T in about 108 patients with ischemic DCM. ...