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Collateral Therapeutics Announces Positive Clinical
Results For Lead Cardiovascular Gene Therapy Product
Large-Scale Pivotal Clinical Trials Planned
SAN DIEGO, March 20 /PRNewswire/ -- Collateral Therapeutics, Inc. (Nasdaq: CLTX - news) today announced positive
preliminary results of a double-blinded, placebo-controlled Phase 1/2 clinical trial of the Company's lead non-surgical
angiogenic gene therapy product candidate, GENERX(TM) (Ad5FGF4), for the treatment of patients with stable exertional
angina due to coronary artery disease. Based on these results, Collateral and its development partners, Schering AG of
Germany and Berlex Laboratories, plan to initiate large-scale Phase 2b/3 pivotal trials to advance the commercial development
of GENERX.
``To the best of our knowledge, this marks the first time that a scientifically well-controlled clinical trial of a non-surgical
cardiovascular gene therapy has produced positive results and demonstrated a safe and well-tolerated treatment effect,' said
Jack W. Reich, Ph.D., Chairman and Chief Executive Officer of Collateral Therapeutics. ``Based on these data, Collateral and
Schering AG plan to meet with the FDA and other health authorities to review clinical development plans designed to support
licensing applications for this product candidate. These results further support Collateral's objective to establish new standards
of care by developing a portfolio of non-surgical cardiovascular gene therapy products that have the potential to provide
simpler and more cost-effective alternatives to currently available treatments for heart disease.'
The AGENT (Angiogenic GENe Therapy) trial was designed as a Phase 1/2 ascending-dose trial having two primary
objectives: (1) to assess the safety of GENERX at a range of dose levels; and (2) to evaluate clinical measures of efficacy and
select appropriate doses of GENERX to take forward into large-scale clinical trials. Sixty-seven patients with stable exertional
angina, chest pain caused by a lack of oxygen in the heart muscle, which is triggered by exertion or emotional stress, were
enrolled at 12 major medical centers across the country. Patients received a one-time, non-surgical, intracoronary
administration of a placebo or GENERX and were evaluated for safety and efficacy for 12 weeks in this double-blind,
placebo-controlled study.
Based on results from this clinical trial, GENERX appeared to be safe and well tolerated at all dose levels evaluated in the
study. In addition, substantial improvements in exercise time on a treadmill were observed at multiple dose levels in patients
treated with GENERX. At one dose level, which will be carried forward into larger clinical trials, more than half of the
GENERX-treated patients exhibited a substantial prolongation of their total time on a treadmill. The extent of prolongation
observed compared favorably to percutaneous transluminal coronary angioplasty and to coronary artery bypass graft surgery.
``It is clear that we have seen very positive biological effects in patients. Based on results from the AGENT trial, the next logical
step is to proceed with expanded clinical trials to fully characterize the therapeutic utility of this treatment approach,' noted
Robert L. Engler, M.D., Professor of Medicine at the University of California, San Diego, and the VA Medical Center, and a
co-founder of the Company, who assisted in the design of the trial. ``The results from this placebo-controlled, double-blind
Phase 1/2 clinical trial confirm the Company's preclinical research and further support the Company's thesis that an
adenoviral-based cardiovascular gene therapy product can be safely delivered to the human heart using a standard catheter, in
order to achieve a positive therapeutic effect based on Collateral's methods of gene therapy.'
In addition, in preparation for including an expanded patient population within the large-scale trials, Collateral and Schering AG
are also currently evaluating a broader population of patients, including patients who previously underwent coronary artery
bypass graft surgery and those with more severe forms of coronary artery disease.
Patient safety is the Company's primary consideration in any clinical trial. The study showed that GENERX appears to be safe
and well tolerated at all dose levels studied. Safety information from the trial has been submitted to appropriate regulatory
agencies in compliance with U.S. federal safety reporting requirements. In addition, the clinical trial protocol was presented to
and approved by the Recombinant DNA Advisory Committee (RAC) at public hearings on June 18, 1998. As reported in
December 1999, the death of one patient enrolled in the trial (which occurred approximately five months after the one-time
product administration) was determined to have been unlikely to be causally related to the therapy, following evaluations by
independent investigators, company medical directors, and an independent safety review panel.
The angiogenic gene therapy product candidate GENERX was developed by Collateral based on scientific discoveries and
technology pioneered by the Company's chief scientific officer and co-founder, H. Kirk Hammond, M.D., and his colleagues at
the VA Medical Center and the University of California, San Diego. Subsequent development of GENERX has been
conducted in close collaboration with Schering AG of Germany, and with Schering's U.S. subsidiaries Berlex Laboratories and
Berlex Biosciences.
GENERX is a non-surgically administered gene therapy designed to stimulate angiogenesis (new blood vessel growth),
providing an alternate route for blood to flow around blocked or clogged arteries. Envisioned as an out-patient procedure that
could be administered by cardiologists, GENERX involves a one-time, non-surgical administration of an adenoviral gene
therapy vector containing the human Fibroblast Growth Factor-4 (FGF-4) angiogenic gene delivered into the coronary arteries
through a standard catheter.
Angina is chest pain caused by myocardial ischemia, a condition in which the amount of oxygen the heart muscle requires
exceeds the amount available due to coronary artery blockage (atherosclerosis). According to the American Heart Association
(AHA), angina affects approximately 6.2 million Americans, with 300,000 new cases diagnosed each year. Angina is a
symptom of coronary artery disease (CAD), which affects more than 60 million Americans and is a leading cause of death in
the United States. Current treatment options for CAD include drug therapy, which is usually life-long, can be costly, and may
be associated with undesirable side effects, or invasive procedures that require hospitalization, including angioplasty and bypass
surgery. According to the AHA, approximately 480,000 angioplasties and nearly 600,000 bypass surgeries are performed
each year in the United States. Collateral's approach to angiogenic gene therapy is being developed to potentially reduce the
need for these interventions by offering a non-surgical alternative that may only require a single treatment.
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) 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.
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, 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.
NOTE: For more information on Collateral Therapeutics, please visit our 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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