So, concern about liver cancer (it was never problem for me) is somehow reduced. I am still puzzled why is *Street* so slow to *figure out*...
Thursday October 25, 7:32 am Eastern Time
Press Release
SOURCE: Collateral Therapeutics, Inc.
GENERX(TM) U.S. Phase 2b/3 Large-Scale Clinical Trial Underway And European Study Receives Authorization to Begin
SAN DIEGO, Oct. 25 /PRNewswire/ -- Collateral Therapeutics, Inc. (Nasdaq: CLTX - news) today announced that its development partner, Schering AG, Germany, (NYSE: SHR - news) has informed the Company that the Medicines Control Agency in the United Kingdom (U.K.) has authorized the initiation of the large-scale Phase 2b/3 clinical trial in the U.K. as part of the European clinical development for GENERX, Collateral's lead product candidate for the potential treatment of stable exertional angina due to coronary artery disease. Patient enrollment for the European trial is expected to begin in January 2002. In addition, the Company reported that the U.S. portion of the GENERX development program is underway and patients are now being enrolled at an initial twelve U.S. medical centers.
Under GENERX's large-scale development program, the U.S.-based Phase 2b/3 study is evaluating the safety and efficacy of GENERX in patients with stable exertional angina due to coronary artery disease. The European-based Phase 2b/3 study will 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 multi-center, randomized, double-blinded and placebo-controlled and the U.S.-based program is expected to enroll patients at up to 100 medical centers. In addition to evaluating exercise duration by treadmill testing, anginal frequency, quality of life and medication usage, and separately, a formal and pre-specified 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.
Under the terms of a collaboration, license and royalty agreement entered into with Schering AG, either Schering AG or its affiliates are responsible for manufacturing clinical materials as well as for conducting and financing these clinical trials for GENERX. Additional information regarding these trials is outlined in Collateral's June 18, 2001 press release.
``These large-scale Phase 2b/3 clinical trials for GENERX represents a significant advancement of Collateral's non-surgical cardiovascular gene therapy programs, and provides further evidence of our leadership position in the global gene therapy industry,'' said Jack W. Reich, Ph.D. chairman and chief executive officer of Collateral Therapeutics. ``Non-surgical angiogenic gene therapy has significant potential to treat the millions of patients with stable exertional angina and carries the potential to transform the practice of cardiovascular medicine.''
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. |
