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Biotech / Medical : CLTX: Celsus Therapeutics -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (31)	2/25/2002 7:06:24 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 40

Collateral Therapeutics Announces the Publication of Results From Angina Gene Therapy Clinical Trial in Circulation, Journal of the American Heart Association SAN DIEGO, Feb. 25 /PRNewswire-FirstCall/ -- Collateral Therapeutics, Inc. (Nasdaq: CLTX - news) today announced the publication of results of a Phase 1/2 clinical trial of GENERX(TM) in Circulation, the medical and scientific journal of the American Heart Association. This study was selected by Circulation as a ``Rapid Access Publication'' and was published Online in advance of the Journal's March 19, 2002 issue date. GENERX (Ad5-FGF4), a non-surgical angiogenic gene therapy is being evaluated as a potential treatment for patients with stable exertional angina due to coronary artery disease. This study was conducted by Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE: SHR - news) under an agreement with Collateral Therapeutics. As researchers reported in Circulation, ``the Angiogenic GENe Therapy (AGENT) trial evaluated the safety and anti-ischemic effects of double blind one time intracoronary infusion of ascending doses of Ad5-FGF4 gene transfer or placebo in 79 patients with CCS class 2 or 3 stable angina. Ad5-FGF4 appeared safe and well tolerated with no immediate adverse effects. Serious adverse events during mean follow up of 311 days were not different. Overall, patients receiving gene therapy tended to have greater improvement in ETT, which was significant in protocol specified subgroups. Angiogenic gene transfer using Ad5-FGF4 shows promise as a new therapeutic approach to patients with angina pectoris.'' An initial report of this study was previously presented at the 50th Annual Scientific Session of the American College of Cardiology as reported in Collateral's press release dated, March 19, 2001. The Circulation article, entitled ``Angiogenic GENe Therapy (AGENT) Trial in Patients with Stable Angina Pectoris'', describes safety and preliminary efficacy data on the use of GENERX, an adenovirus serotype 5 encoding for Fibroblast Growth Factor-4 (FGF4) for the potential treatment of stable exertional angina. ``This Phase 1/2 AGENT clinical trial was an encouraging first in-man study which served as one important foundation for the advancement of GENERX into a large-scale Phase 2b/3 worldwide development program,'' said Jack W. Reich, Ph.D. chairman and chief executive officer of Collateral Therapeutics. ``We are pleased with the number of new studies and data that continue to support our clinical development program of GENERX in patients with stable angina.'' As previously reported by Collateral on June 18, 2001, Schering AG, based on data from this AGENT Phase 1/2 clinical study, has initiated a large-scale worldwide development program for GENERX. This development program includes two studies, a U.S.-based Phase 2b/3 clinical study as well as a European-based Phase 2b/3 clinical study. The U.S.-based Phase 2b/3 study, which will be conducted at up to 100 medical centers is evaluating the safety and efficacy of GENERX in patients with stable exertional angina due to coronary artery disease, who do not require immediate revascularization. The European-based Phase 2b/3 study is designed to evaluate stable angina patients with advanced coronary artery disease who are not considered candidates for interventions such as angioplasty and bypass surgery and/or patients who are unlikely to have positive outcomes from such interventions. These studies are multi-center, randomized, double-blinded and placebo-controlled. Upon completion, it is expected that results of these studies, together with results from the AGENT 1/2 study and other development activities could be used to support a marketing application for product registration to the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).