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Positive 2nd Interim Analysis of Phase 2b RESTORE-CLI Clinical Trial, Aastrom Biosciences (ASTM)

ASTM plans to rapidly move Into a Phase 3 Program in 2011.                                                                                                                       

ASTM announced (11/18/10) that an interim analysis of all 86 patients enrolled in the  Phase 2b RESTORE-CLI clinical trial shows that the study achieved both its primary safety endpoint and primary efficacy endpoint of time to 1st occurrence of treatment failure.

  • The findings related to time to first occurrence of treatment failure were statistically significant (p=0.0132);
  • Further analyses show a clinically meaningful reduction of 56% in treatment failure events;
  •  The RESTORE-CLI trial is the largest fully controlled cell-therapy study ever conducted in critical limb ischemia (NYSE:CLI);
  • This interim analysis includes results from all 86 patients who were randomized and enrolled in the trial, 72 of whom were eligible for treatment and have completed at least 6 months of follow-up and 62 of whom completed 12 months of follow-up;
  •  Analysis of the data for amputation-free survival, a secondary measure which the study was not powered to demonstrate, showed a clinically meaningful reduction in event rates of 24%, but did not show statistical significance (p=0.5541);
  • Importantly, analysis of the data between the interim results shows similar treatment event rates (22-25%) for the treated group, but an unexpected reduction in event rates for the control group from 50% to 29%.

In 2/10, ASTM reported results from an interim analysis of data from this trial that showed:

  • Statistically significant clinical benefit favoring Aastrom’s autologous cellular therapy for the first 46 patients enrolled in the trial, in both time to first occurrence of treatment failure (a composite endpoint consisting of major amputation of treated leg, all-cause mortality, doubling of total wound surface area from baseline and de novo gangrene; p=0.005) and amputation-free survival (p=0.038).

Results of the second interim analysis were presented in a non-CME satellite session of the VEITHsymposium™ in New York City by principal investigator Richard Powell, M.D., chief of vascular surgery at Dartmouth-Hitchcock Medical Center in Lebanon, NH.

“I am very optimistic about the treatment response rates we have seen in patients in this trial so far. These interim data suggest that there is a clear and clinically meaningful therapeutic effect at work in treated patients. I look forward to examining the benefits of this treatment in the context of a larger Phase 3 study,” said Dr. Powell.

The 2 interim analyses were done to provide information to support the design and execution of Aastrom’s Phase 3 CLI program. 

  • In October, ASTM announced plans to initiate a Phase 3 CLI clinical development program under special protocol assessments (NYSE:SPA) with a Fast Track designation by the FDA.