Sanofi's critical limb ischemia drug flunks PhIII

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Sanofi-Aventis's high hopes for an experimental therapy designed to prevent death or amputation among patients with critical limb ischemia were dashed by its failure in a long running late-stage test, with the drug data coming in no better than a placebo. Marc Cluzel, Sanofi's R&D chief, said he was "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."

Sanofi recruited more than 500 patients to compare Tamaris--which researchers had hoped would help patients by spurring growth of new blood vessels to help limbs damaged by embolism or thrombosis--with a placebo. But the therapy failed to "demonstrate the superiority of NV1FGF over a 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."

Cluzel added that Sanofi's research team would go back to the drawing board to evaluate all it options. The late-stage failure is also bad news for Vical, which provided its non-viral DNA delivery technology to the partnership. The affliction triggers some 150,000 amputations each year in the U.S. and Europe.

- see the report from Dow Jones
- read the Bloomberg story

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