DURHAM, N.C. -- In the first demonstration of the therapeutic benefit of an agent that stimulates blood vessel growth, a group of cardiologists have improved the functional abilities of patients with painful blockages in the blood vessels in their legs.

The phase II randomized double-blind placebo controlled trial aimed to test whether an "angiogenic growth factor" could increase the duration of walking by patients with intermittent claudication -- a condition marked by clogged blood vessels in the legs -- which leads to severe and often debilitating pain during walking. This pain is similar to the pain of angina caused by clogged coronary arteries.

The results of the trial, led by Duke University Medical Center cardiologist Brian Annex, M.D., and Robert Lederman, M.D., then with the University of Michigan and now with the National Heart Lung Blood Institute, were published in the June 15, 2002 issue of the journal Lancet.

While the researchers are not certain that the agent, known as recombinant fibroblast growth factor-2 (rFGF-2), actually triggered the creation of new blood vessels, they found that treated patients could significantly increase their peak walking times compared to similar patients who did not receive the agent.

"This is the third large multi-center randomized placebo-controlled trial looking at the therapeutic use of an angiogenic agent and the first to show a positive result in its primary endpoint," said Annex. "This study provides the strongest and most convincing data to date that an angiogenic agent can have a positive effect in humans."

For nearly a decade, researchers have been testing different angiogenic agents for the treatment of heart disease. Researchers hope that these agents can stimulate new blood vessel growth into damaged heart muscle, or around arterial blockages. But so far, the results of recent studies in humans have not been encouraging, Annex said
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Contact: Richard Merritt
merri006@mc.duke.edu
919-684-4148
Duke University Medical Center
13-Jun-2002