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September 23, 2010

Sanofi-Aventis’ Fibroblast Growth Factor Gene Therapy Fails in Phase III

Firm still deciding on fate of drug and will present full trial results in November. [© Sebastian Kaulitzki - Fotolia.com]

  • Sanofi-aventis has yet to decide the future of its angiogenic therapy Temusi® (NV1FGF; riferminogen pecaplasmid), after the treatment bombed in a Phase III trial. The year-long global Tamaris study was designed to evaluate whether NV1FGF therapy was better than placebo at preventing major amputation or death due to any cause in critical limb ischemia patients who were ineligible for revascularization.

    255 patients received either intramuscular NV1FGF or placebo every two weeks over a six-week period. Full results from the study will be presented at the forthcoming "American Heart Association Congress" in November, and won’t be released before that time, the firm says. NV1FGF is a nonviral plasmid-based local gene-delivery system for human fibroblast growth factor (FGF-1).  

    “We are disappointed that NV1FGF failed to achieve significance in the Tamaris trial,” admits Marc Cluzel, M.D., executive vp of R&D at sanofi-aventis. “We are evaluating all options on the NV1FGF development and remain committed to innovation in diseases where there are major healthcare needs and no therapeutic alternative.”

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