>>GAITHERSBURG, Md., Nov. 13 /PRNewswire/ -- GenVec Inc. (Nasdaq: GNVC - news), a leading biotechnology company in the development of gene-based pharmaceuticals, announced today the final results from its Phase I study with BioBypass in patients with peripheral vascular disease (PVD), the progressive narrowing of blood vessels in the legs estimated to affect more than 10 million Americans.
BioBypass angiogen is GenVec's lead cardiovascular product candidate and is designed to improve poor blood flow in the legs, heart and other tissues by stimulating new blood vessel formation.
The Phase I study was an open-labeled dose escalating study in a total of 33 patients with severe debilitating peripheral vascular disease. The study, which was primarily a safety study, demonstrated that BioBypass, given by 20 intramuscular injections in and around the area in need of new blood vessels was well tolerated with injection site swelling being the only consistently recorded drug-related side effect.
Although this was a Phase I study, early indications of biologic activity were observed. The Absolute Claudication Distance (ACD), which is the distance a patient can walk on a treadmill before being forced to stop due to leg pain, trended upward in the patients in whom it was measured. Following treatment, the mean improvement was 1.2 minutes at 30 days, 1.9 minutes at 3 months, 2.6 minutes at 6 months, and 4.9 minutes at 12 months (approximately 77% improvement). The ACD is the endpoint, which would typically be used by the FDA to assess clinical benefit. An increase in quality of life (QOL) as estimated by a Walking Impairment Questionnaire, a questionnaire which assesses to what extent improvements in walking results in improvements of QOL was also seen.
``These data, while open-labeled, and non-randomized, are encouraging, and provide some early indications that BioBypass may be useful in the treatment of patients with peripheral vascular disease,'' said Henrik S. Rasmussen, MD, PhD, Vice President of Clinical Research & Regulatory Affairs for GenVec. ``We are now awaiting the results of a major randomized, double-blind, placebo- controlled Phase II study, well underway in more than 20 sites throughout North America.''
The double-blind, placebo-controlled study is expected to enroll over 100 patients suffering from moderate to severe intermittent ischemic leg pain who are not currently candidates for other revascularization procedures. The study will assess walking distance on a treadmill and patient well-being before and after treatment, as well as safety and drug tolerance. ``The primary endpoint in the Phase II study is an improvement in Absolute Claudication Distance,'' stated Dr.Rasmussen.
The results were presented yesterday at the Annual Scientific Sessions of the American Heart Association in Anaheim, California by Dr. Sanjay Rajagopalan from the University of Michigan Medical Center in Ann Arbor, a principle investigator for the clinical studies of BioBypass.
It is estimated that approximately 12 percent of the U.S. population has some level of peripheral vascular disease, resulting in more than $12 billion in medical costs annually. Current therapies, ranging from risk factor modification and exercise programs to angioplasty and bypass surgery, generally do not stop the progression of the disease and are inadequate in a large number of patients as illustrated by the fact that more than 120,000 amputations are being performed in the United States alone as a consequence of this disease.<<
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