Study Analyzes Gene Therapy For Patients At High Risk For Amputation

Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD), a frequent medical condition that causes a decrease in blood flow to the legs due to narrowing of the arteries, and is associated with an increased risk for a heart attack or stroke. CLI can cause extreme leg pain at rest and make it more difficult for wounds on the legs to heal, and can frequently lead to amputation or death.

The TALISMAN (Therapeutic Angiogenesis Leg Ischemia Study for the Management of Arteriopathy and Non-healing ulcers) 201 study examined 107 patients with CLI and compared the results of patients who received either placebo or an intramuscular administration of a novel gene therapy (NV1FGF). NV1FGF is a DNA plasmid which fosters the formation of new blood vessels. This is the first double-blind, placebo-controlled study in CLI subjects who are not eligible for revascularization (surgical bypass or angioplasty) aiming to decrease the risk of amputation. Despite no improvement on wound healing, data shows that this new treatment significantly reduced the risk of amputation, and may potentially lead to lower mortality rates in patients. In this critically ill population, no difference was observed in the incidence of adverse events between the study drug and placebo.

"Patients suffering from critical limb ischemia experience an increased danger of amputation and death," said Dr. Sigrid Nikol, M.D., University Hospital of Münster in Germany and lead author of the study. "Evaluating promising new treatment options is the optimal way to ensure these patients are given the best prognosis possible while maintaining their quality of life. NV1FGF will be further evaluated in phase III in CLI patients with the objective of reduction of amputation and death."