Sanofi-aventis Phase III Tamaris trial fails to meet primary endpoint

Tamaris is a randomised, double blind, placebo controlled study designed to evaluate the safety and efficacy of NV1FGF in patients with critical limb ischemia and skin lesions who are not eligible for revascularization.

The primary endpoint was to demonstrate the superiority of NV1FGF vs placebo in the prevention of major amputation or death from any cause over 12 months, whichever came first, in critical limb ischemia patients who were not eligible for revascularization.

Sanofi-aventis executive vice president, Research & Development Marc Cluzel said that they are disappointed that NV1FGF failed to achieve significance in the Tamaris trial, and for patients who are suffering from the dramatic consequences of this disease and are hoping for new treatments.