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news.Gene-based medicines developer GenVec has announced the launch of a phase IIb trial of its Biobypass angiogen for the treatment of patients with severe coronary artery disease.
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The trial, named NOVA, will evaluate the effects of Biobypass on exercise tolerance, heart function, symptoms and quality of life in approximately 129 patients suffering from moderate to severe chest pain due to advanced coronary artery disease.
The NOVA trial is being conducted under a research collaboration between GenVec and the cardiology division of Cordis Corporation, a Johnson & Johnson company. Biobypass will be administered using the Cordis Noga technology with the Nogastar mapping catheter and Myostar injection catheter.
Two Danish medical centers have begun enrollment already and GenVec expects that approximately 15 centers in Europe and Israel will participate in the NOVA study.
Biobypass promotes production of GenVec’s proprietary form of vascular endothelial growth factor (VEGF) to stimulate the growth of new blood vessels in areas of the heart lacking sufficient blood flow. This condition, known as ischemia, triggers chest pain in patients with severe coronary artery disease.
In an earlier phase II trial known as the REVASC study, Biobypass was administered during surgery. The Biobypass-treated group showed significant clinical benefit, including an increased ability to exercise.