Injections of a Sanofi-Aventis experimental gene therapy treatment cut the risk of amputations in patients with severely decreased blood flow to the legs, according to results of a mid-stage trial reported Sunday.
The product, called NV1FGF, was designed to spur formation of new blood vessels in patients with the most advanced stage of peripheral arterial disease.
The disease results from narrowing of the arteries in the legs. It can cause extreme leg pain and increases the risk of having a heart attack or stroke. The lack of blood flow also makes it difficult for wounds on the legs to heal, possibly leading to limb amputations and death.
In a study of 107 patients, researchers tested injections of Sanofi’s NV1FGF compared with a placebo.
The Sanofi treatment did not produce an improvement in wound healing, but it did reduce the chances of needing an amputation, researchers said.
Thirty-seven percent of patients who received the gene therapy treatment had an amputation during the year-long study, compared with 55.4 percent of others who got the placebo.
The patients in the study had critical limb ischemia, the most severe form of peripheral arterial disease.
The findings were presented at a meeting of the American College of Cardiology by lead author Dr. Sigrid Nikol of University Hospital of Munster in Germany.