Sanofi-Aventis Initiates Phase III TAMARIS Trial
Sanofi-aventis has begun the 500-patient Phase III TAMARIS trial of its NV1FGF angiogenesis therapy, which is based on Vical’s nonviral DNA delivery technology, to treat critical limb ischemia.
According to sanofi-aventis and Vical, the plasmid DNA therapy encodes fibroblast growth factor 1, which stimulates the growth of blood vessels and reduces the need for amputations in patients suffering from critical limb ischemia.
Patients in the double-blind, placebo-controlled Phase III trial will receive four 4-mg doses to be administered by intramuscular injection at two-week intervals, the companies said.
Sanofi-aventis previously reported results from a Phase II trial in 107 patients demonstrating a statistically significant lower amputation rate in patients receiving NV1FGF compared with those receiving placebo.
Sanofi-aventis expects to file for marketing approval in 2010.