FDAnews
www.fdanews.com/articles/85997-corautus-stops-enrollment-in-angina-study

CORAUTUS STOPS ENROLLMENT IN ANGINA STUDY

April 12, 2006

Corautus has halted enrollment in a Phase IIb trial evaluating its treatment for severe angina, after a data monitoring board said that the poor risk to benefit profile of the drug made it futile to continue.

Based on available efficacy data, the independent data monitoring board said that enrollment should be terminated under the current protocol as it saw very little chance for significant efficacy as to the primary endpoint relative to the safety risk.

The company will continue to collect efficacy data until the last patient previously enrolled in the trial has been followed for six months. At that time, the company plans to lock the study database and perform unblinded endpoint analyses of VEGF-2 efficacy.