FDA partially lifts hold on Corautus' VEGF-2 study

Atlanta, USA-based clinical-stage biopharmaceutical company Corautus Genetics, says that the Food and Drug Administration has partially removed the hold it imposed on the firm's Phase IIb GENASIS trial. The study, which is designed to assess the efficacy of the angiogenesis stimulating agent vascular endothelial growth factor-2 (VEGF-2), delivered in the form of a DNA plasmid, on diseased heart muscle, was stopped after the FDA raised questions about the drug's catheter delivery system

In March of this year, Coratus suspended enrollment of patients into the GENASIS program in order to address the FDA's concerns. Subsequently, the FDA said that Coratus has satisfactorily addressed the majority of the issues raised, but added that the Investigational New Drug application in question will remain on "partial hold" until it has submitted additional data in relation to the Stiletto endocardial catheter system used in the trial, which is manufactured by US firm Boston Scientific.

In response, Coratus said that it expects to submit the additional information, as well as the efficacy and safety analysis from the data assessed prior to the program's suspension, to the FDA later this year.