Biotech Tracker News - Study Supports BioBypass Development
November 21, 2002. Phase II data presented at a late breaking session of the American Heart Association meetings continue to support the development of Genvec’s (NASDAQ: GNVC) BioBypass angiogen (AdVEGF121.10) for the treatment of patients with blood flow-limiting coronary artery disease. BioBypass is a gene-therapy based agent that induces expression of VEGF in the target cells. Genvec is developing BioBypass with Pfizer (NYSE: PFE). The current data support efforts of larger-scale trials that could demonstrate BioBypass’s viability for the treatment of individuals with advanced coronary artery disease who are not candidates for contemporary invasive revascularization strategies.  The 71-patient REVASC clinical trial is a randomized, controlled study of the injection of BioBypass into heart muscle. The goal is to stimulate angiogenesis (growth of new blood vessels) in the hopes of permitting increased blood flow and oxygen delivery to areas of the heart muscle (myocardium) deprived of blood flow and oxygen (ischemia). Myocardial blood flow and oxygen deprivation leads to acute coronary syndromes characterized by angina, unstable angina, myocardial infarction, and sudden cardiac death.  Patients with severe, advanced coronary artery disease were randomized to receive either BioBypass plus standard-of care (n=36) or standard-of-care (35). The majority of REVASC study subjects had already received standard revascularization procedures such as angioplasty and coronary artery bypass grafts, and were not considered candidates for additional surgical intervention. The primary endpoint was the electrocardiographic (EKG) manifestation of ischemia known as “ST segment depression.” Secondary endpoints assessed patients’ symptoms and function, and included time to chest pain on a treadmill, total exercise time, patient quality of life assessment (Seattle Angina Questionnaire), and health care professionals’ assessment of patient function (Canadian Cardiovascular Society Angina Class). Outcomes were assessed at study entry and three and six months after treatment.  Biobypass recipients achieved clinically significant advantages in terms of:  improvements in ST segment depression rates at 3 months (statistical trend, p=0.3)  improvements in ST segment depression rates at 6 months (statistically significant, p=0.024)  total time to chest pain on the treadmill and total exercise time on the treadmill at both 3 and 6 months  at 6 months, time to angina increased by 37% from entry (statistically significant, p=0.002)  3 month post treatment time to angina reporting was conspicuously absent  improvements in patient quality of life were at 6, 12, and 26 weeks  significant improvements in patient function at 6, 12, and 26 weeks.  BioBypass’s adverse effect profile was reassuring. This adenovirus-based construct is one of the most promising gene therapeutics in clinical development.
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