CORAUTUS'S ANGINA STUDY DID NOT MEET EFFICACY ENDPOINT

Corautus Genetics has announced that the final efficacy results from its GENASIS Phase IIb trial, which evaluated VEGF-2 in Class III or IV angina, did not achieve a statistically significant difference from placebo in any active dose group for the primary efficacy endpoint. The primary efficacy endpoint was an improvement of at least one minute in exercise tolerance time (ETT) from baseline to three months. The data indicated considerable overlap in results between the active and placebo groups for the secondary endpoints as well, and no clear dose effect was seen.

The final efficacy results are consistent with the preliminary data reviewed earlier this year by the independent data monitoring committee (DMC), according to Richard Otto, president and CEO of Corautus. "At that time, the DMC reviewed summary ETT data on 220 patients and recommended that enrollment in the GENASIS trial be terminated, a recommendation that Corautus accepted. When the trial was terminated, 295 patients had been enrolled. The final data from the trial has now been received and studied," he said in a company release.

He also said that the placebo effect was much more significant and was sustained longer than expected. A majority of patients in all treatment arms significantly improved from their baseline status, and there was no significant difference between the placebo group and the active dose group.