Gene Therapy for CAD Shows Promise

The multicenter study, reported in the March 2002 issue of Circulation, was the first trial of intracoronary gene therapy.

Currently available treatment options for coronary artery disease include drug therapy, angioplasty and bypass surgery. A nonsurgical treatment, therapeutic angiogenesis is performed via catheterization – the insertion of a tiny tube into the blood vessels surrounding the heart in order to deliver a growth factor gene into the coronary arteries. For this experimental therapy, a product called growth factor gene is then delivered through the tube into the coronary arteries.

In the first phase of the current study, 79 patients between the ages of 30 and 75 and diagnosed with mild to moderately severe stable angina. All underwent catheterization, with 60 of the patients receiving a growth factor gene, and the remaining 19 received a placebo. None of the patients or investigators in the double-blind study knew who received the active therapy until the end of the study.

To evaluate the effectiveness of the treatment, patients underwent exercise treadmill testing at 4 weeks and 12 weeks following treatment. Patients who had received the growth factor gene, or therapeutic angiogenesis, showed a larger improvement in exercise ability than those patients in the placebo group. The therapy appeared to be safe and well tolerated with no major adverse effects.

"This research has taken an initial, but significant, step in a new direction in the treatment of coronary artery disease,” said Dr. Matthew Watkins, associate professor of medicine at the University of Vermont (Burlington, USA) and one of the lead authors. It leads towards a treatment, which does not involve a mechanical solution or standard drug therapy, that may be of particular benefit to patients with chronic angina who are not good candidates for additional angioplasty or bypass surgery. We are encouraged by these results and look forward to the findings from the Phase 3 trial.”




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