Public Release: 

Study analyzes gene therapy for patients at high risk for amputation

Injection reduces and delays risks of amputation in patients with limb ischemia

American College of Cardiology

A new randomized study presented today at the American College of Cardiology's 55th Annual Scientific Session investigates an innovative treatment for critical limb ischemia, or lack of arterial blood supply and oxygen to the legs, using a therapeutic approach to generate new blood vessels. ACC.06 is the premier cardiovascular medical meeting, bringing together more than 30,000 cardiologists to further breakthroughs in cardiovascular medicine.

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."


Contacts In Atlanta (March 11-14): Georgia World Congress Center 404-222-5812

Dr. Nikol will be presenting the results of "Therapeutic Angiogenesis with Intramuscular NV1FGF Improves Amputation-Free Survival in Patients with Critical Limb Ischemia" on Sunday, March 12 at 2:30 p.m.

The American College of Cardiology ( represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.06 and the ACC inaugural i2 Summit, the first-ever meeting for interventional cardiologists, will bring together more than 30,000 cardiologists and cardiovascular specialists to share the newest discoveries in the treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.

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