title: NV1FGF, a pCOR plasmid-based angiogenic gene therapy for the treatment of intermittent claudication and critical limb ischemia.
abstract: Gene transfer of FGF1 has been demonstrated to successfully promote angiogenesis. NV1FGF, a novel pCOR (conditional origin of replication) DNA plasmid-based gene delivery system, is in development by Sanofi-Aventis for the local expression of FGF1 in the treatment of peripheral vascular disease, and has demonstrated potential to induce therapeutic angiogenesis. Preclinical studies using NV1FGF demonstrated restoration in capillary and arteriolar density in rabbit and hamster models of hind limb ischemia. In phase I and phase II clinical trials, NV1FGF effectively reduced the number of amputations and deaths in the trials, with minimal toxicity, and in conjunction with a sustained increase in mRNA and protein levels of FGF1 and its receptors in patients with critical limb ischemia (CLI). These results prompted a phase III trial of NV1FGF in patients with CLI, with the aim of improving quality of life. Thus, the results of the phase III clinical trial may be a significant advancement in the field of medical science, widening the reach of this therapeutic approach to effectively cure intermittent claudication and CLI.
authors.affiliation: University of Connecticut Health Center, Department of Surgery, Molecular Cardiology and Angiogenesis Laboratory, 263 Farmington Avenue, Farmington, CT 06030-1110, USA. nmaulik@neuron.uchc.edu
authors.forename: Nilanjana
authors.initials: N
authors.lastname: Maulik