Skip to main content

STUDY ANALYZES GENE THERAPY FOR PATIENTS AT HIGH RISK FOR AMPUTATION

Pressmeddelande   •   Mar 13, 2006 12:00 CET

CONTACT:

Kellie Hotz, 202-955-6222
khotz@spectrumscience.com

Amy Murphy, 301-581-3476
amurphy@acc.org

In Atlanta (March 11-14):
Georgia World Congress Center
STUDY ANALYZES GENE THERAPY FOR PATIENTS AT HIGH RISK FOR AMPUTATION

NV1FGF Injection Reduces and Delays Risks of Amputation in Patients with Limb Ischemia
ATLANTA, GA (March 12, 2006) — A new randomized study presented today at the 55th
American College of Cardiology 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 through narrowing
of the arteries and increases the 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 201 study examined 107 patients with CLI and compared the results of
patients who received either an intramuscular administration (medication injected directly into
muscle tissue) of a novel gene therapy (NV1FGF), or a placebo. NV1FGF is a DNA plasmid
used to foster the formation of new blood vessels. This is the first double blind, placebocontrolled
study in CLI subjects who are not eligible for revascularization (surgical bypass or
angioplasty) with hopes of decreasing 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 in the incidence of adverse events was observed 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 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”

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 PM.

The TALISMAN (Therapeutic Angiogenesis with Intramuscular NV1FGF Improves
Amputation- free Survival in Patients with Critical Limb Ischemia) 201 study was sponsored by
sanofi-aventis

About the American College of Cardiology:
The American College of Cardiology (www.acc.org) 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.

Bifogade filer

PDF-dokument