Scimitar Equity Blog

       RESTORE-CLI results met … primary safety and efficacy endpoints

The final analysis of data from all 86 randomized patients in the RESTORE-CLI trial showed that the trial met its primary safety and efficacy endpoints, demonstrating a statistically significant improvement in the time to first occurrence of treatment failure (TTF) at 12 months.

• The double blind, placebo-controlled RESTORE-CLI clinical trial randomized 86 men and women between the ages of 18 and 90 with a diagnosis of CLI and no previous major amputations;
• The RESTORE-CLI clinical trial assessed the safety and ability of ixmyelocel-T to restore damaged tissue in a lower extremity affected by critical limb ischemia (CLI);
• CLI was defined as persistent, recurring ischemic pain for at least 2 weeks, or ulcerations (grade 4 or 5 on the Wagner scale) or gangrene of the foot or toe;
• Participants in the clinical trial were randomized 2:1 to receive intramuscular injections of ixmyelocel-T or an electrolyte solution into the affected limb. Patients were followed for 12 months after treatment and otherwise received normal standard of care;
• The clinical trial was conducted at 20 medical centers throughout the US.

The Bottom Line: The trial met its primary safety and efficacy endpoints. End-points were NOT disclosed due to embargoe(s) … why didn’t they wait for the full disclosure? So, call/webcast was weak on specifics!  ASTM plans to present the full data from the RESTORE-CLI trial at an appropriate medical meeting in 4/11. In the clinical trial, the assessment of TTF included 4 components: major amputation of the treated leg, all-cause mortality, doubling of wound size from baseline, and de novo gangrene. All of these components together comprised the primary composite endpoint for this trial.  CLI patients with tissue loss (i.e., de novo gangrene and increasing wound size) are 5 times more likely to experience amputation. As a result, tissue loss represents a widely accepted predictor of amputation risk in CLI patients. ASTM has been actively working with the FDA to finalize the no option SPA and expects to conclude those discussions in the next several weeks. So, what NEW data … was disclosed? Reached agreement … on what issues . Transparency is the … ISSUE! What has taken … so long …??