New Study Indicates That Non-Surgical FGF-4 Gene Therapy Is Useful In the Treatment of Heart Failure
Monday March 27, 7:45 am Eastern Time
Company Press Release
SOURCE: Collateral Therapeutics
SAN DIEGO, March 27 /PRNewswire/ -- Collateral Therapeutics (Nasdaq: CLTX - news) today announced that a new placebo controlled preclinical study led by the Company's chief scientist, H. Kirk Hammond, M.D., and Associate Director of Research, M. Dan McKirnan, Ph.D., found that intracoronary delivery of the human gene Fibroblast Growth Factor-4 (FGF-4) increased heart function and reduced the size of dilated hearts in the setting of heart failure. The research, published in the peer-reviewed journal Cardiac and Vascular Regeneration, indicates that FGF-4 gene therapy is useful in the treatment of heart
failure.
``These are the first data, to our knowledge, that demonstrate that FGF gene therapy can improve heart function in heart failure,' said Dr. Hammond, Associate Professor of Medicine, University of California, San Diego, and Vice President, Research and founding scientist of Collateral Therapeutics. ``These preclinical study findings are important because they could potentially provide important insights into the development of a new non-surgical therapeutic option for patients with dilated heart failure.'
Heart failure is a condition in which the heart has enlarged and its pumping ability has decreased. The most common cause of heart failure in the U.S. is coronary artery disease. Dr. Hammond and his colleagues at Collateral Therapeutics, the Veteran's Affairs Medical Center and University of California, San Diego, examined whether intracoronary delivery of the FGF-4 gene expressed in an adenovirus vector could improve heart function in heart failure.
The blinded placebo-controlled study used pacing-induced heart failure in pigs, a preclinical model that has been used by scientists for decades to study heart disease. The researchers measured heart function before and sequentially after intracoronary delivery of saline (control) or human FGF-4 expressed in an adenovirus vector. The researchers found that the gene-treated group showed significantly improved regional cardiac function and also experienced a reduction in the size of the heart over the three-week study
period.
``If these results translate favorably to humans, it would represent a significant advancement in treating this serious disease,' Dr. Hammond stated, ``a disease that affects millions of patients in the United States and is the leading cause of hospitalization for older patients.'
The technology covered under this study has been exclusively licensed to Collateral Therapeutics, which plans to develop a
non-surgical gene therapy using the FGF-4 gene for the treatment of patients with heart failure. The FGF-4 gene, which promotes
angiogenesis, has been exclusively licensed from New York University. Angiogenesis is a biological process that stimulates the
growth of new blood vessels. Collateral Therapeutics is also using FGF-4 gene therapy to develop a treatment for patients with
clinical coronary artery disease and recently announced positive preliminary results from a Phase 1/2 trial in patients with angina.
The Company is also developing an additional non-surgical gene therapy product for heart failure, one that uses an adenylate
cyclase gene to improve heart function via controlled amplification of cardiac contractility.
Collateral Therapeutics, Inc., headquartered in San Diego, is a leader in the discovery and development 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) increasing myocardial contractility, as a treatment for congestive heart failure; and
(3) heart muscle regeneration, to improve cardiac function for patients who have suffered a heart attack.
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 their 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
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