FDA OKs gene therapy trial for Boston and Corautus:
This article was originally published in Clinica
The US FDA has approved the start of a phase IIB clinical trial of a gene therapy technology for severe cardiovascular disease that is being developed jointly by Corautus Genetics and Boston Scientific. The study will test the efficacy and safety of defined doses of Corautus' angiogenesis-promoting vascular endothelial growth factor-2 (VEGF-2) gene percutaneously delivered via Boston's Stiletto endocardial direct injection catheter. The catheter is modelled to deliver genes to the heart without deactivating them, a problem that, according to Boston, may occur with non-gene specific catheters. The randomised, double-blinded, dose-ranging and placebo-controlled study will involve up to 404 patients with class III or IV angina at around 20 US centres. In July 2003, Atlanta, Georgia-based Corautus entered into a strategic alliance with Boston to develop, commercialise and distribute VEGF-2 gene therapy products.