Corautus submits response to FDA
This article was originally published in Clinica
Executive Summary
Corautus Genetics has filed a response to the US FDA regarding the agency's clinical hold on a trial of its investigational VEGF-2 gene therapy product for angina. The hold had been imposed due to potential safety concerns with the delivery of the product, and in April 2006, Corautus decided to terminate the enrolment in the trial - called GENASIS - after 295 patients had already been treated. "We did not, and still do not, believe the events were related to the therapeutic," said Richard Otto, the Atlanta, Georgia firm's president and CEO. The company's response to the FDA was developed after evaluating the safety concerns with its partner Boston Scientific, maker of the Stiletto catheter system used to deliver the VEGF product percutaneously. The company is still hopeful that it will be able to start a phase III clinical trial of the product.