Everybody's skeptical until the Phase III results come in.
I'm patient. I'll wait. The potential reward for those in early is absolutely huge.
Plus there's another good prospect for SCIO to gain a solid revenue source without the upfront R&D effort/costs.
read on.
Ian
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GenVec Announces Start of Phase II Trials with BIOBYPASS For Peripheral Vascular Disease
GAITHERSBURG, Md., Aug 10, 2000 /PRNewswire via COMTEX/ -- GenVec, Inc., a leading biotechnology company in the development of gene-based pharmaceuticals, announced today that Phase II human clinical trials have begun with BIOBYPASS(R) angiogenic agent in patients with peripheral vascular disease (PVD), the progressive narrowing of blood vessels in the legs estimated to affect more than 30 million Americans.
BIOBYPASS(R) angiogenic agent is GenVec's lead product candidate and is designed to improve poor blood flow (ischemia) in the heart, legs and other tissues by stimulating new blood vessel formation. In addition to PVD, the new gene-based therapy is being studied for the treatment of coronary artery disease.
"PVD is a debilitating disease that is poorly treated with current therapies," said Dr. Paul H. Fischer, president and chief executive officer of GenVec. "BIOBYPASS(R) angiogenic agent is an innovative approach being evaluated for use in patients with this widespread condition. The commencement of this second randomized Phase II trial marks yet another significant milestone in the development of this new therapy."
The double-blind, placebo-controlled clinical trial 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.
GenVec recently announced the start of Phase II clinical trials of BIOBYPASS(R) angiogenic agent in patients with coronary artery disease. BIOBYPASS(R) angiogenic agent consists of a proprietary gene transfer system, commonly referred to as a vector, carrying the gene coding for vascular endothelial growth factor isoform 121 (VEGF 121). GenVec has exclusively licensed the patent-protected VEGF 121 gene from Scios Inc. for all gene therapy applications on a worldwide basis.
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 artery bypass grafts, generally do not stop progression of the disease. In certain patients with diffuse disease or vessels that are too small to access, standard approaches are inadequate, resulting in more than 120,000 amputations annually in the United States alone.
GenVec, Inc. is a privately held biotechnology company focused on the development and commercialization of novel gene-based therapies for the treatment of major medical needs. The company combines its patented gene transfer technologies with proprietary therapeutic genes to create product candidates that address needs in the areas of cardiovascular disease, cancer, ophthalmology and other therapeutic areas.
Statements herein that are not descriptions of historical facts are "forward-looking" and subject to risk and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including risks relating to the early stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialization, if any of the company's proposed products (such as marketing, regulatory, patent, product liability, supply, competition and other risks).
SOURCE GenVec, Inc.
CONTACT: Jeffrey W. Church, Chief Financial Officer of GenVec, Inc |