Thursday December 6, 7:30 am Eastern Time
Press Release
SOURCE: Collateral Therapeutics, Inc.
American Heart Association's Circulation Research Reports On Safety Record of Cardiovascular Gene Therapy Clinical Trials
SAN DIEGO, Dec. 6 /PRNewswire/ -- Collateral Therapeutics, Inc. (Nasdaq: CLTX - news) today highlighted results from a recent review article published in the August 31, 2001 issue of Circulation Research, Journal of the American Heart Association (Circ Res. 2001;89:389-400), which provides a review of safety data from clinical trials of cardiovascular gene therapy. The review was based on an analysis of data that have been publicly discussed and formally reported. This review is part of a series on cardiovascular gene therapy and was prepared by researchers from the Shaughnessy Center for Clinical Genetics, St. Elizabeth's Medical Center and Tufts University School of Medicine.
The review article reports that clinical trials of cardiovascular gene therapy, whether using viral or nonviral vectors, have thus far disclosed no evidence indicative of inflammatory or other complications, including death, directly attributable to the vector used. Indeed, despite the fact that initial trials of cardiovascular gene therapy targeted patients with end-stage vascular disease, including critical limb ischemia and refractory myocardial ischemia, the mortality for patients enrolled in clinical trials of cardiovascular gene therapy reported to date appears to compare favorably with mortality for similar groups of patients in contemporary controlled studies of medical or interventional therapies. ``This review, which was prepared by researchers independent of Collateral Therapeutics, provides important overall insights regarding the body of safety data in the rapidly evolving field of cardiovascular gene therapy,'' noted Christopher J. Reinhard president and chief operating officer of Collateral Therapeutics. The full-text of this article can be viewed on the Investor Relations page of Collateral's website ( www.collateralthx.com ) in the News Release section. Collateral Therapeutics has received permission from the American Heart Association, Circulation Research to distribute this article.
Safety information about the Phase 1/2 AGENT trial, which was a U.S.-based, randomized, double-blind, placebo-controlled study for Collateral's lead product candidate, GENERX(TM) was also included in this review article. GENERX, a non-surgical angiogenic gene therapy, is being developed by Schering AG, Germany (FSE: SCH; NYSE: SHR) under an agreement with Collateral. GENERX consists of an adenovirus serotype 5 vector that administers fibroblast growth factor-4 (FGF-4), which is being studied for the potential treatment of stable angina due to coronary artery disease.
Collateral Therapeutics, Inc., headquartered in San Diego, is a leader in the discovery and development of innovative gene therapy products for the treatment of cardiovascular diseases. Collateral Therapeutics is developing non-surgical cardiovascular gene therapy products focused on: (1) angiogenesis, as a treatment approach for coronary artery disease, peripheral vascular disease and congestive heart failure; (2) myocardial adrenergic signaling, as a treatment for congestive heart failure; and (3) heart muscle regeneration, to improve cardiac function for patients who have suffered a heart attack. GENERX(TM), a non-surgical angiogenic gene therapy designed for the potential treatment of stable exertional angina due to coronary artery disease, is now in large-scale Phase 2b/3 trials in the United States and is expected to be in large-scale clinical trials in Europe in January 2002. GENVASCOR(TM), Collateral's second angiogenic gene therapy is entering Phase 1/2 studies in Europe to evaluate a diverse group of patients with varying severities of peripheral vascular disease. |
