Aastrom terminates CLI program, halving staff

Aastrom Biosciences Inc. (NASDAQ:ASTM) fell $0.44 (38%) to $0.71 on Wednesday after announcing that it will no longer develop its only product, ixmyelocel-T, to treat critical limb ischemia (CLI) and will instead focus R&D resources on developing the product for dilated cardiomyopathy (DCM). The company also said it will reduce headcount by 35 (50%) to about 36, which the company expects to reduce operating expenses by about 50%.

Aastrom, which terminated the Phase III REVIVE trial of ixmyelocel-T for CLI, said DCM and other rare diseases may require smaller studies for ixmyelocel-T, 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 Phase IIb ixCELL-DCM trial to evaluate intra-myocardial ixmyelocel-T in about 108 patients with ischemic DCM. Ixmyelocel-T is an autologous cell therapy containing adult stem and progenitor cells that is made using Aastrom's Tissue Repair Cell technology. ...