To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: The Human iNOS Gene Licensed From The University of Pittsburgh URL: http://www.pslgroup.com/dg/CE5A.htm Doctor's Guide October 9, 1996
PITTSBURGH and ROCKVILLE, Md., Oct. 9, 1996 -- The University of Pittsburgh and GenVec, Inc. announced today the signing of an exclusive, worldwide license agreement providing GenVec with the rights for all gene transfer pharmaceutical applications of the human form of inducible nitric oxide synthase (iNOS) gene. The iNOS gene, has been combined with GenVec's proprietary gene transfer system and is being evaluated initially as a treatment for vascular complications related to restenosis following angioplasty and steriosis arising from the use of artery-to-venous (AV) shunts. Details of the transaction were not disclosed. The human iNOS gene was identified and cloned by a research team lead by Timothy Billiar, M.D., a researcher and surgeon at the University of Pittsburgh Medical Center (UPMC). iNOS catalyzes the conversion of L-arginine to nitric oxide, a molecule with a range of cardiovascular actions, including regulation of blood vessel function. Local production of nitric oxide declines when the endothelium is damaged by procedures used to open occluded blood vessels such as angioplasty or surgical bypass using vein grafts or prosthetic grafts. Subsequent to the damage, platelet activation and aggregation occurs and ultimately causes the release of factors that stimulate the growth of vascular smooth muscle cells. This latter phenomena leads to stenosis (closure) or restenosis (reclosure) of the damaged blood vessels. In 1993, approximately 380,000 angioplasty procedures were performed in the United States, with restenosis occurring in 30 to 50 percent of the estimated blood vessels within six months of the procedure. In patients using AV shunts, which are prosthetic grafts used to facilitate dialysis in individuals with chronic renal failure, essentially all develop occlusive complications due to vascular stenosis. According to the National Institute of Diabetes and Digestive and Kidney Diseases, approximately 187,000 people utilized dialysis in the United States in 1995. "The influence of the nitric oxide in the cardiovascular system is pervasive and extraordinary," said Dr. Billiar. "Nitric oxide is the most important endogenous vasodilator, and normal blood vessel function is dependent on appropriate levels of nitric oxide production. GenVec, with its advanced gene transfer systems, can deliver therapeutic genes in vivo, and is an excellent partner for the development and commercialization of this very potent source of nitric oxide." "Nitric oxide is a short-lived molecule and if produced locally has the potential to avoid the side effects encountered when administered systemically. Therefore the use of gene transfer technology to achieve the local, sustained production of nitric oxide for regulating vascular cell growth and other potential applications is compelling and creates a promising product candidate," said Paul H. Fischer, Ph.D., Executive Vice President and Chief Operating Officer of GenVec. "The iNOS technology is an important addition to our cardiovascular program." Earlier this year GenVec announced it had acquired exclusive worldwide rights for all gene transfer pharmaceutical applications of vascular endothelial growth factor (VEGF 121) from Scios, Inc. VEGF has been shown in animal models to promote the growth of new blood vessels (angiogenesis), creating the potential for a biological version of a bypass around a blocked artery. The products BioByPass(TM), combines the VEGF gene with GenVec's proprietary gene transfer system and will be initially developed for the treatment of coronary artery disease. The University of Pittsburgh has established a comprehensive patent portfolio covering iNOS technology throughout the world. The portfolio includes an issued composition of matter U.S. patent covering the human iNOS gene. GenVec, will sponsor further research in Dr. Billiar's laboratory and receive exclusive rights to inventions arising from the research. GenVec is a privately held biotechnology company focused on the development and commercialization of gene transfer pharmaceuticals utilizing advanced, proprietary gene transfer systems and medically relevant genes. GenVec's therapeutic programs are in the areas of cardiovascular disease, neurological disease, pulmonary disease and cancer. The University of Pittsburgh is a comprehensive research university which enrolls more than 32,000 students. The University of Pittsburgh receives over $250 million annually in sponsored research funding and is one of the top ten recipients of NIH funding in the United States. 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