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(Circulation. 2002;105:e9083.)
© 2002 American Heart Association, Inc.

Cardiovascular News

Ruth SoRelle, MPH

Circulation Newswriter

Angiogenic Gene Therapy Appears Safe to Treat Stable Angina

In the Angiogenic GENe Therapy (AGENT) trial, 5 ascending doses of a replication-incapable adenovirus called Ad5 coupled to a gene for human fibroblast growth factor were administered to patients with stable angina in a double-blind, placebo-controlled trial. The results, reported in this week’s issue of Circulation, were that the single, intracoronary administration of the gene therapy was safe and well tolerated. Cindy L. Grines, MD, of the Division of Cardiology at William Beaumont Hospital in Royal Oak, Michigan, was first author on the report. Those participating came from William Beaumont Hospital, the University of Vermont, Minnesota Heart Clinic in Minneapolis, Johns Hopkins University Medical Center in Baltimore, Mount Sinai Medical Center in New York, Berlex Laboratories in Montville, NJ, the University of California at San Diego, and the Veterans Affairs San Diego Healthcare System (Circulation. 2002;105:1291–1297).

Adverse events reported included fever of <24 hours’ duration in 3 patients who received the highest dose and transient increases in liver enzymes in 2 patients in lower-dose groups. A total of 79 patients were enrolled in the study. Sixty patients were enrolled in 1 of 4 treatment groups and 19 were in the placebo group. The doses were delivered by one-time intracoronary infusions at ascending levels of from 3.2x10⁸ to 3.2x10¹¹ viral particles. Although some patients in all groups suffered worsening angina, there was no significant difference among them. One patient who received the treatment developed unstable angina 145 days after treatment. That patient died while . . . [Full Text of this Article]