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Trial to Test Gene Therapy for Angina in Women
Date:9/4/2007

Novel treatment promotes blood vessel growth in heart muscle, researchers say

TUESDAY, Sept. 4 (HealthDay News) -- A trial testing a genetically engineered treatment in women who have angina, the piercing chest pain that can bedevil the millions of Americans with heart disease, has been given fast-track status by the U.S. Food and Drug Administration.

The study will enroll about 300 women at 50 medical centers in the United States, said Dr. Randall Moreadith, chief medical officer of Cardium Therapeutics Inc., the San Diego company that developed the therapy. They will receive infusions of a harmless virus engineered to carry a gene that promotes development of new blood vessels. The pain of angina is caused by insufficient blood flow to the heart muscle.

The fact that the FDA is pushing a trial of the therapy indicates the urgent need for a new angina treatment, said Christopher J. Reinhard, chief executive office of Cardium. "These are patients who are getting maximum drug medication, have had bypass surgery and continue to have recurrent angina. They have nowhere else to turn."

Two earlier studies that included both men and women found no overall improvement with the treatment, according to a report in the Sept. 11 issue of the Journal of the American College of Cardiology.

"But when we broke the data down by gender, there was a striking difference in women on exercise treadmill duration," Moreadith said. "Then we saw that every one of the clinical endpoints in women lined up. That was a surprise finding to us."

The treatment uses two technologies developed at different academic institutions -- the FGF-4 gene, discovered at New York University, and delivery by infusion through a catheter placed in a blood vessel, developed at the University of California.

"We have been in a program involving four multi-center studies, with the same delivery mechanism and the same product,
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