PR Newswire/Les Echos/
Sanofi-aventis press release
Clinical Update on TAMARIS Phase III Trial for NV1FGF
Paris, France - September 22, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE:
SNY) announced today that the Phase III TAMARIS trial evaluating the
investigational angiogenic therapy NV1FGF (riferminogen pecaplasmid) did not
meet its primary endpoint. 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.
"We 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" said Marc Cluzel, M.D., PhD,
Executive Vice President, Research & Development, 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
The full results of this trial will be presented at the American Heart
Association Congress, on November 16, 2010 and are embargoed until this date.
About the TAMARIS trial
TAMARIS is a randomized, 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 study
was conducted in more than 170 sites in 30 countries on five continents and
enrolled a total of 525 patients being administered either NV1FGF or placebo
intramuscularly every 2 weeks over a 6 week period.
Riferminogen pecaplasmid (NV1FGF) is a non viral plasmid-based gene local
delivery system for human fibroblast growth factor (FGF-1). FGF-1 promotes
angiogenesis and induces the formation of new blood vessels that could improve
blood flow of the limbs of CLI patients.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Tel: +33 (0)220.127.116.11.28
Media Relations: Tel. : (+) 33 1 53 77 44 50 - E-mail : MR@sanofi-aventis.com
Investor Relations : Tel. : (+) 33 1 53 77 45 45 -
E-mail : IR@sanofi-aventis.com
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