Well, nothing is instant.
While market was anxious about Generx future and Schering collaboration, this news (for while) may intrigue few investors.
Miljenko
Monday June 18, 7:30 am Eastern Time
Press Release
SOURCE: Collateral Therapeutics, Inc.
Collateral Therapeutics Announces New Worldwide Development Program for GENERX(TM)
Large-scale Cardiovascular Gene Therapy Trials to Be Launched
SAN DIEGO, June 18 /PRNewswire/ -- Collateral Therapeutics, Inc. (Nasdaq: CLTX - news) today announced that its development partner, Schering AG, Germany plans, subject to the approval of the regulatory authorities, to initiate a large-scale, worldwide, clinical development program for GENERX(TM) (Ad5-FGF4), a non-surgical angiogenic gene therapy product candidate for the treatment of patients with stable exertional angina due to coronary artery disease. The worldwide development program calls for a Phase 2b/3 trial to be conducted in the United States and another, separate Phase 2b/3 trial to be conducted in Europe. A meeting of U.S. clinical investigators was held on June 16 and 17, 2001. Based on the terms of Collateral's collaboration, license and royalty agreement with Schering AG, that was entered into in May 1996, Schering AG or its affiliates would be responsible for conducting and financing any such trials for GENERX.
Under the planned development program, a U.S.-based Phase 2b/3 Pivotal study would be conducted at up to 100 medical centers to evaluate the safety and efficacy of GENERX in patients with stable exertional angina due to coronary artery disease. In addition, a European-based pivotal study would evaluate 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 intended to be multi-center, randomized, double-blinded and placebo-controlled. GENERX would be non-surgically administered to the heart via one-time intracoronary infusion through a standard cardiac catheter. Each study would be monitored by an independent data safety monitoring board. Details of the proposed study are subject to the approval of the regulatory authorities.
It is expected that the studies would evaluate two dose levels (10(9) viral particles (v.p.) and 10(10) v.p.). The studies' primary endpoints would be prolongation of exercise time on a treadmill (ETT) at 12 weeks following administration to patients with a maximum ETT of 12 minutes or less at baseline, based on the current study protocol. Additional assessments would include anginal frequency, quality of life and medication usage. Separately, a formal and prespecified outcomes analysis on the incidences of death, heart attack and hospitalizations for worsening angina, including patients requiring angioplasty and bypass surgery is also intended to be performed. Upon completion, it is expected that results of these studies, along with data from the 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).
``This is an important step forward in the development of our angiogenic gene therapy programs,'' said Jack W. Reich, Ph.D., chairman and chief executive officer of Collateral Therapeutics. ``Based on the encouraging data that we collected from our initial Phase 1/2 trial and other information now available from investigators, we look forward to entering, as soon as reasonably practicable, these large-scale, comprehensive cardiovascular gene therapy trials, and continuing our relationship with Schering AG. Schering AG is also currently preparing four separate European Phase 1/2 clinical trials to evaluate our angiogenic gene therapy product candidate which is designed as a non-surgical treatment for patients with peripheral vascular disease.
``Conducting two pivotal clinical trials in tandem would enable us to broaden the spectrum of patients to be evaluated on a worldwide basis,'' added Dr. Reich. ``Consistent with our Phase 1/2 clinical trial, the U.S. Phase 2b/3 study is expected to evaluate patients with stable exertional angina, who are symptomatic despite anti-anginal medication, and who do not require immediate revascularization. This would also include patients who are not optimal candidates for revascularization. The European Phase 2b/3 study is expected to evaluate patients with more advanced coronary artery disease who have no treatment options and/or are not optimal candidates for angioplasty and bypass surgery. When taken together, these two studies would now cover a broad range of patients treated for angina, and this worldwide development program would seek to enroll approximately 1,000 angina patients. If approved by the regulatory authorities, data from these clinical trials could be used to support marketing applications in the U.S., the European Union and other countries.''
Ad5-FGF4 Product Candidate
Ad5-FGF4 is a non-surgically administered gene therapy designed to stimulate angiogenesis (new blood vessel growth) which may provide alternate routes for blood to flow into oxygen-deprived ischemic areas of the heart due to blocked or narrowed arteries. Envisioned as a procedure that could be administered by interventional cardiologists, Ad5-FGF4 involves a one-time, non-surgical administration of an adenoviral gene therapy vector containing the human Fibroblast Growth Factor 4 (FGF4) angiogenic gene delivered into the coronary arteries through a standard catheter. Ad5-FGF4 is used in this release as a generic term for a product candidate (GENERX(TM)) consisting of a human replication-deficient serotype 5 adenovirus in which the E1A/E1B genes are replaced by the human FGF4 gene driven by a CMV promoter.
Coronary Artery Disease
Angina, a symptom of coronary artery disease, 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. Coronary artery disease (CAD) affects more than 12 million Americans and is a leading cause of death in the United States. Current treatment options for CAD include drug therapy or invasive procedures that could require hospitalization, including angioplasty and bypass surgery. According to the AHA, approximately 480,000 angioplasty procedures and nearly 600,000 bypass surgery procedures are performed each year in the United States. Angiogenic gene therapy is being developed to potentially reduce the need for these interventions by offering an effective and safe addition to current treatment options.
Peripheral Vascular Disease
Peripheral vascular disease (PVD) is a general term used to describe diseases affecting blood vessels of the legs and is usually caused by decreased blood flow to arteries in the limbs due to artherosclerosis (fatty plaque deposits). PVD is a serious and painful condition that affects an estimated 726,000 Americans, most often in men over 50 years of age, and results in over 100,000 lower limb amputations annually in the United States. Current treatments include life-long drug therapy and in more advanced cases, amputation or surgical interventions such as arterial grafting, angioplasty or surgical removal of the fatty plaque deposits. Collateral believes that gene therapy may provide an important additional option in the management of these patients.
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. or its partners will be able to advance or 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. |
