Sanofi-Aventis has received some disappointing news from the clinic as the firm revealed that its investigational angiogenic therapy for limb ischaemia failed in a late-stage study.
The French drugmaker said the Phase III TAMARIS trial evaluating NV1FGF (riferminogen pecaplasmid) did not meet its primary endpoint. This was to demonstrate the treatment's superiority versus placebo in the prevention of major amputation or death from any cause over 12 months in critical limb ischaemia (CLI) patients who were not eligible for revascularisation.
NV1FGF is a non-viral plasmid-based gene local delivery system for human fibroblast growth factor. Sanofi notes that FGF-1 promotes angiogenesis and induces the formation of new blood vessels that could improve blood flow of the limbs of CLI patients.
The future looks fairly bleak for the treatment, however. Sanofi research chief Marc Cluzel said “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”. He added that "we are evaluating all options on the NV1FGF development".
The full results of the trial will be presented at the American Heart Association meeting on November 16.