Levosimedan enters Phase III for Low cardiac Output Syndrome-Oxygen Biotherapeutics

Duke Clinical Research Institute will serve as the coordinating center for the Phase III levosimendan study . Drs. John H. Alexander and Rajendra Mehta will be investigators for the Phase III trial. The FDA and Oxygen Biotherapeutics have reached agreement that a single successful trial will be enough to support approval of levosimendan for the LCOS (Low Cardiac Output Syndrome) indication.

The trial will be conducted at approximately 50 major cardiac surgery centers in North America enrolling patients undergoing coronary artery bypass graphs (CABG) and/or mitral valve surgery who are at risk for developing LCOS. Enrollment is expected to begin in the third quarter of 2014 and the study, seeking to enroll 760 patients, will take an estimated 18 months.