The angiogenic therapy NV1FGF, being investigated to help restore blood flow to critical limb ischemia (CLI) patients, failed to show superiority over placebo in the phase III TAMARIS trial, according to a statement issused by Paris-based Sanofi-Aventis.
TAMARIS is a randomized, double blind, placebo controlled study that was conducted in more than 170 sites in 30 countries on five continents and enrolled a total of 525 patients who were administered either NV1FGF or placebo intramuscularly every two weeks over a six-week period.
The primary endpoint was to demonstrate the superiority of NV1FGF (riferminogen pecaplasmid) versus placebo in the prevention of major amputation or death from any cause over 12 months, whichever came first, in CLI patients who were not eligible for revascularization.
"We are disappointed that NV1FGF failed to achieve significance in the TAMARIS trial, and ... are evaluating all options on the NV1FGF development," said Marc Cluzel, MD, PhD, executive vice president, research & development, Sanofi-Aventis.
The full results of the TAMARIS trial will be presented at the American Heart Association meeting on Nov. 16 in Chicago.
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, according to the company.