Sanofi-Aventis has presented encouraging data from a Phase IIb trial of its blood vessel-stimulating gene therapy NV1FGF, suggesting it could be effective in avoiding amputation in patients with compromised blood flow to the legs.

On the strength of the Phase II data Sanofi-Aventis plans to advance NV1GF into Phase III testing in the fourth quarter of 2006.

The study looked at how the gene therapy could promote new blood vessel growth in patients with critical limb ischaemia, reduced blood flow to the legs caused by peripheral artery disease. The condition is often associated with wounds on the legs that fail to heal, and in severe cases can lead to amputation of the affected limb. It also increases the risk that patients will suffer a heart attack or stroke.

In the 107-patient study, NV1FGF treatment cut the amputation rate to 37% from 55% in a placebo group. Sigrid Nikol, principal investigator in the Phase IIb trial and professor of molecular cardiology at the University Clinic in Munster, Germany, presented the data at the annual meeting of the American College of Cardiology in Atlanta.

The upcoming Phase III trial is designed to be conducted in patients with critical limb ischaemia, with a combined trial endpoint of major amputation or death. Sanofi-Aventis is planning to submit the therapy for regulatory approval by 2009/2010.

The Phase IIb trial was sponsored by Centelion, a wholly-owned subsidiary of Sanofi-Aventis.