>>GAITHERSBURG, Md., Jan. 8 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News), announced today that it has entered into a research collaboration with the Cordis Cardiology Division of Cordis Corporation, a Johnson & Johnson company, to study the clinical benefit of BIOBYPASS® in a procedure involving guided delivery of the angiogenic agent directly into targeted regions of the heart in patients with severe coronary artery disease using the Cordis NOGASTAR® Mapping Catheter and MYOSTAR(TM) Injection Catheter.
"We are enthusiastic about our collaboration with Cordis Corporation, a recognized leader in the field of cardiovascular devices, as it provides a solid platform to advance both BIOBYPASS and the NOGASTAR and MYOSTAR catheters into the next stage of clinical development," said William Enright, GenVec's Director of Corporate Development. "Our ability to administer BIOBYPASS using Cordis Corporation's minimally invasive catheter system represents an outstanding commercial opportunity for GenVec," he concluded.
The purpose of the collaboration is to conduct a randomized, double-blind, placebo controlled study of GenVec's cardiovascular product candidate, BIOBYPASS. Clinical benefit will be assessed in this multi-center study, which will be conducted in Europe and is expected to enroll up to 125 patients with heart disease. GenVec and Cordis will collaborate on regulatory matters and share in the clinical trial costs. GenVec will supply BIOBYPASS and Cordis will provide the NOGASTAR and MYOSTAR mapping and injection catheters and training to the interventional cardiologists conducting the trial. GenVec will retain commercial rights to BIOBYPASS, while commercial rights to the NOGASTAR mapping catheters and MYOSTAR injection catheters will be retained by Cordis.
BIOBYPASS produces the angiogenic protein, VEGF-121 (vascular endothelial growth factor-121), which has been shown pre-clinically to stimulate new blood vessel formation in poorly perfused (ischemic) tissue.
As previously reported in a late-breaking session at the American Heart Association Scientific Sessions in November 2002, BIOBYPASS showed statistically significant positive results in a Phase II randomized, controlled study when administered during surgery in patients with CAD. Patients enrolled in this study were considered "no option" patients and were not candidates for standard revascularization procedures, such as angioplasty and coronary artery bypass (CABG).
The feasibility of administering BIOBYPASS with the Cordis NOGASTAR and MYOSTAR Injection Systems was reported at the American College of Cardiology Scientific Sessions in March 2003.
Coronary artery disease affects 12.8 million Americans resulting in approximately 500,000 deaths annually.<<
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