Thursday June 28, 5:33 pm Eastern Time
Press Release
SOURCE: Collateral Therapeutics, Inc.
Collateral Announces Discovery of a Novel Cardiac Gene Expression Activator For Its Heart Muscle Regeneration Program
Preclinical Research Published in Cell Suggests That Myocardin Is Highly Potent and May Contribute to the Formation of Heart Muscle Cells
SAN DIEGO, June 28 /PRNewswire/ -- Collateral Therapeutics, Inc. (Nasdaq: CLTX - news) today announced that researchers at the University of Texas Southwestern Medical Center at Dallas (UT Southwestern) identified a novel cardiac-specific gene expression activator for Collateral's heart muscle regeneration program. In preclincial studies published in the June 29, 2001 issue of Cell, Eric N. Olson, Ph.D., chairman of molecular biology at UT Southwestern showed that a novel and highly potent transcription factor (a gene regulator), termed Myocardin, is expressed specifically in cardiac and smooth muscle cells and is capable of up-regulating a number of cardiac-specific genes in non-muscle cells.
``There is great interest in identifying genes that control the formation of heart cells because such genes might ultimately provide opportunities for converting non-cardiac cells into cardiac muscle cells through gene therapy technology,'' said Dr. Olson, lead author of this study and a key collaborator for Collateral's gene discovery research for its heart muscle regeneration program. ``Myocardin is a novel cardiac regulatory gene that switches on other cardiac genes and appears to be essential for the formation of heart cells in the embryo. Ongoing studies are aimed at determining whether Myocardin alone or together with other factors can be used to generate heart cells for cardiac repair.''
``Traditional views have concluded that once the heart is damaged by a heart attack, functioning muscle cells are replaced by non-functioning scar tissue. Collateral's research collaboration with UT Southwestern is centered around the concept that heart muscle can be regenerated by gene therapy,'' said Christopher J. Reinhard, president and chief operating officer of Collateral Therapeutics. ``These new findings provide Collateral researchers with some valuable insights. Myocardin is shown to increase the expression of a number of cardiac-specific genes in fibroblasts. Fibroblasts are non-muscle cells found in heart muscle, which are involved in the formation of scar tissue following a heart attack. Dr. Olson's research indicates that Myocardin may play a role as a phenotypic switch enabling the conversion of fibroblasts into cardiomyocytes (contracting heart muscle cells). This preclinical research may open the way to developing non-surgical gene therapy products designed to improve a patient's heart muscle function following injury from a heart attack.''
In September 2000, Collateral entered into an agreement with the University of Texas Southwestern Medical Center at Dallas to exclusively license certain human genes discovered by researchers at UT Southwestern. Collateral is also sponsoring additional gene discovery research for its heart muscle regeneration program. Under the terms of the agreement, Collateral obtains exclusive worldwide rights to certain genes discovered for use in gene therapies for the treatment of heart disease, including heart failure and heart attack. In return, UT Southwestern Medical would receive licensing fees and royalties based on worldwide sales of products that Collateral may develop based on technology licensed under the agreement.
Myocardial Infarction (heart attack) background
A heart attack occurs when a blockage in a coronary artery severely restricts or completely stops blood flow to a portion of the heart. When blood supply is greatly reduced or stopped for more than a short time, heart muscle cells die. Heart muscle cells generally lack the ability to multiply to replace the dead cells. In the healing phase, after a heart attack, white blood cells migrate into the area and remove the dead heart muscle cells, and fibroblast cells proliferate and form a fibrous collagen scar in the affected region of the heart. Following a heart attack, the heart's ability to maintain normal function will depend on the location of the damage and the amount of damaged tissue. The American Heart Association estimates that in 2001 over 40% of the approximate 1.1 million patients who have a heart attack in a given year will die as a result of it. Current therapeutic treatments for heart attacks focus on acute care following a heart attack and on long-term care to limit the development of heart failure and possible recurrent heart attack. A form of drug therapy may be used to dissolve a blood clot immediately following a heart attack. After a heart attack, patients generally are required to take medicines to alleviate symptoms and to make certain lifestyle changes, such as altering diet, increasing exercise levels and stopping smoking.
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. The Company's lead product candidate, GENERX(TM), a non-surgical gene therapy designed for the potential treatment of angina due to coronary artery disease is entering two large-scale Phase 2b/3 Pivotal trials in the United States and Europe and GENVASCOR(TM) is entering Phase 1/2 studies in Europe for four separate medical indications.
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. or its partners will be able to commercially develop cardiovascular gene therapy products, that necessary regulatory approvals will be obtained or that any clinical trials will be successful or that the proposed treatments will prove to be safe and/or effective. 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 the 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.
SOURCE: Collateral Therapeutics, Inc. |
