Cardiovascular gene therapy: current status and therapeutic potential.
GenVec, in collaboration with Pfizer (formerly Parke-Davis), is developing AdGVVEGF121.10 (BioBypass), a gene therapy involving the 121-residue isoform of vascular endothelial growth factor (VEGF), licensed from Scios, for the potential treatment of coronary artery disease (CAD) and peripheral vascular disease (PVD) . By March 2000, phase II trials in CAD had commenced , , . By August 2000, phase II trials were also underway for PVD . The initial phase II trial will include approximately 70 patients with severe CAD who are not candidates for bypass surgery and will assess exercise capacity and patient well-being, before and after treatment, as well as safety and drug tolerance . Scios licensed the gene transfer applications of VEGF121 to GenVec in June 1996 . In September 1997, GenVec entered into an agreement with Parke-Davis, a subsidiary of Warner-Lambert (now Pfizer), to develop the therapy . In May 1999, Warner-Lambert signed an agreement with Bioscience for a device for the administration of AdGVVEGF121.10 1325443]. In May 2000, Merrill Lynch predicted a US filing in the first half of 2003 . In January 2001, AG Edwards predicted the product would generate $70 million in revenues to Pfizer and $12 million in royalties to GenVec in 2005. In February 1999, GenVec was awarded US-05846782, covering vectors for targeting the transfer of therapeutic genes to specific tissues in the human body .