Ixmyelocel-T: Phase IIb data

Data from a second interim analysis of the double-blind, U.S. Phase IIb RESTORE-CLI trial in 86 patients showed that Aastrom's expanded autologous mixed cell therapy injected intramuscularly met the primary efficacy endpoint of significantly increasing time to first occurrence of treatment failure vs. placebo (p=0.0132). Additionally, the cell therapy produced a 56% reduction in treatment failure events vs. placebo. The cell therapy missed the secondary endpoint of significantly increasing amputation-free survival vs. placebo (p=0.5541), with a 24% reduction in the incidence of amputation or death. Aastrom said the study was not powered to detect statistical significance on the amputation-free survival endpoint. Additionally, data from both a February interim analysis of the trial and the current analysis showed a similar rate of amputation-free survival (22-25%), whereas a reduction to 29% in the current analysis from 50% in the February analysis was observed for the placebo group. Aastrom said the reason behind the reduction in the placebo group is unknown. ...