Corautus Genetics Inc. is terminating patient enrolment in its GENASIS Phase IIb clinical trial based on the recommendation of its independent Data Monitoring Committee (DMC). The DMC recommended to the company that, based on available efficacy data, enrolment should be terminated under the current protocol as the DMC saw very little chance for significant efficacy as to the primary endpoint relative to the safety risk signal it saw.

GENASIS is a randomized, double-blind, dose-ranging and placebo controlled Phase IIb clinical trial, originally planned to enrol 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial has been conducted in approximately 30 leading cardiac medical centres throughout the United States.

According to the company release, 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. Safety data will be followed for a period of 12 months from the date the last patient was enrolled.

As reported on March 14, 2006, Corautus voluntarily suspended enrolment in its GENASIS trial to fully investigate three recent serious adverse events that the Company believes were not associated with its biologic. At that time, 295 patients had been enrolled in the trial, which was originally scheduled to enrol 404 patients. In response to the Company's action, the FDA placed the trial on clinical hold.