OBI Posts LCOS Trial Protocol

Oxygen Biotherapeutics, Inc. (OBI) has posted the protocol of its Phase III trial for levosimendan on ClinicalTrials.gov. The protocol, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass,” is available here.

OBI previously selected Duke University’s Duke Clinical Research Institute (DCRI) to conduct the Phase III trial of the levosimendan. The trial will be conducted in approximately 50 major cardiac surgery centers in North America and will enroll patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery who are at risk for developing low cardiac output syndrome (LCOS). The trial is a double-blind, randomized, placebo-controlled study intended to enroll 760 patients.

The protocol includes a review of the control arm event rate for the first 200 patients randomized in the trial. The study population can be enriched to a higher percentage of patients with a greater degree of left ventricular dysfunction to increase the control event rate. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.

Levosimendan, which was discovered and developed by Orion Pharma, is a calcium sensitizer developed for IV use in hospitalized patients with acutely decompensated heart failure. It is currently approved in more than 50 countries for this indication but not available in the U.S.