DURHAM, N.C. - Like hearts, legs can also suffer from "attacks" when too little blood flows through clogged and narrowed arteries. And like angina in a heart, this lack of oxygen-rich blood to muscles that need it produces pain. Leg by-pass surgery and angioplasty can help some patients, but most people with leg clots walk as little as possible to avoid the pain.

Now, a novel therapy is being tested to treat this condition, known medically as "intermittent claudication." Researchers are using an "angiogenesis growth factor" to create new blood vessels around clogged leg arteries. Tests of these factors in heart disease have been ongoing, but this trial, led by physicians from Duke University Medical Center and the University of Michigan, is by far the largest study of angiogenesis in leg arteries.

The biologic drug being studied, called recombinant basic fibroblast growth factor (rFGF-2), has the potential to promote the growth of blood vessels around blockages, said Duke cardiologist Dr. Brian Annex.

"Potentially, this investigational drug may increase blood flow to the legs, which would increase exercise capacity and improve patients' quality of life," Annex said. He added that use of such angiogenesis factors in the legs "may even be more straightforward than in the heart where the circulation and delivery can be more complicated."

Annex and co-principal investigator, Dr. Robert Lederman, from Michigan, are organizing a 22-hospital, 180-patient trial that is randomized and placebo controlled. That means that neither the patients nor the physicians involved know who is receiving the drug or a "dummy" substance delivered twice, one month apart, by injection into arteries in both legs near the patient's hipbone.

Chiron Corp., makers of rFGF-2, is funding the Phase II clinical trial, which is being dubbed "TRAFFIC" - Therapeutic Angiogenesis with FGF For Intermittent Claudication. The study is bein
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Contact: Renee Twombly
Twomb001@mc.duke.edu
919-684-4148
Duke University Medical Center
9-Jan-2000