News Release Today. No volume today. CHF is a huge market. I may buy more if it falls below 10.
Tuesday April 20, 8:07 am Eastern Time
Company Press Release
SOURCE: Collateral Therapeutics, Inc.
Collateral Therapeutics Presents Additional Data to Support the
Commercial Development of Non-Surgical Gene Therapy Products for Congestive Heart Failure
SAN DIEGO, April 20 /PRNewswire/ -- Collateral Therapeutics (Nasdaq: CLTX - news) today announced that its most advanced preclinical study to date provides additional evidence that non-surgical gene therapy represents a viable therapeutic approach for congestive heart failure (CHF), a debilitating and often fatal disease characterized by weakened heart contractions. These data are important because they provide the first evidence that the AC-6 gene, which boosts the production of the enzyme that drives the heart to beat stronger, can be efficiently delivered non-surgically using an adenovirus in a way that may be applicable to treating patients. The findings were presented today by H. Kirk Hammond, MD and his colleagues Drs. N.C. Lai, David M. Roth, and Mei Hua Gao at Experimental Biology '99, the annual meeting of the Federation of American Societies for Experimental Biology.
The researchers used Collateral's proprietary non-surgical method of gene therapy to administer a deactivated virus (adenovirus) containing the AC-6 gene (type 6 adenylate cyclase) to normal pigs by intracoronary injection using a standard catheter. They measured left ventricular contractile function and cardiac output in response to stimulation of the heart before and after gene transfer and reported a substantial increase in both parameters (p>0.0001). Control animals that were given an adenovirus carrying a control gene showed no effect. No adverse effects were observed. The researchers concluded that non-surgically inserting the AC-6 gene into the heart allows the heart to beat stronger when stimulated. These findings build on previous research conducted by Dr. Hammond's laboratory, which have been published in peer-reviewed scientific journals including Circulation and the Proceedings of the National Academy of Sciences, demonstrating that increased levels of an enzyme called adenylate cyclase (AC) increases the strength of heart contractions.
''We are excited about this study because it marks the first time our research has advanced beyond transgenic (genetically-manipulated) animal studies and supports the use of adenovirus as an effective vehicle to deliver the AC-6 gene,'' said Dr. Hammond, a cardiologist and Associate Professor of Medicine, University of California, San Diego, and founding scientist of Collateral Therapeutics. ''We are hopeful that these results will translate to successful therapy for patients with heart failure; trials we hope to initiate soon.''
Collateral Therapeutics is commercially developing the AC-6 gene therapy treatment for CHF as part of its pipeline of non-surgical cardiovascular gene therapy products. Distinct from its angiogenesis program now being evaluated in a clinical trial in patients with angina, the AC-6 gene therapy program is based on Collateral's myocardial adrenergic signaling technology and represents the Company's second gene therapy product in development. Collateral plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration before the end of the year and anticipates initiating
clinical trials in patients with heart failure in the first half of 2000.
Congestive heart failure, a condition in which the heart is unable to pump sufficient blood to meet the body's needs, affects 4.7 million Americans with approximately 400,000 new cases diagnosed each year. It is the most frequent reason for hospitalization in people over age 65. Currently, treatment usually involves a program of rest, proper diet and various drugs that help to increase the strength of heart contraction, eliminate excess salt and water, and decrease stress on the weakened heart. These drugs are associated with many side effects and are costly since they need to be taken over an entire lifetime. Gene therapy for heart failure could potentially circumvent these problems.
Collateral Therapeutics, Inc., headquartered in San Diego, is a leader in the discovery, development and commercialization of innovative non-surgical 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. In May 1996, Collateral Therapeutics entered into a strategic alliance with Schering AG, Germany, to develop and commercialize products based on the Company's angiogenesis gene therapy technology. In May 1998, Collateral Therapeutics, together with it's strategic partner, Schering AG, began a Phase 1/2 clinical trial for the Company's lead product GENERX(TM), a non-surgical angiogenic gene therapy product for the treatment of patients with stable exertional angina which is being conducted at ten major U.S. medical centers. The Company completed an initial public offering led by Bear, Stearns & Co., in July 1998.
Statements in this press release that are not strictly historical may be ''forward-looking'' statements, which involve risks and uncertainties. There can be no assurance that Collateral Therapeutics, Inc. will be able to commercially develop cardiovascular gene therapy products and that necessary regulatory approvals will be obtained or that any clinical trials will be successful. The actual results may differ from those described in this press release due to risks
and uncertainties that exist in the Company's operations and business environment, including, without limitation, the Company's early stage of product development and the limited experience in development of gene therapies in general, its dependence upon proprietary technology and current competition, history of operating losses and accumulated deficits, the Company's reliance on collaborative relationships, and uncertainties related to clinical trials, safety, efficacy, the ability to obtain the appropriate regulatory approvals, patent protection and market acceptance, as well as other risks detailed from time to time in
the Company's filings with the Securities and Exchange Commission. The Company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
NOTE: For more information on Collateral Therapeutics, please visit the Company's web site at www.collateralthx.com. News releases are also available through PR Newswire's Company News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by Collateral Therapeutics, please call 800-758-5804, extension 128401.
SOURCE: Collateral Therapeutics, Inc.
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