Oxygen Biotherapeutics (NASDAQ:OXBT) is prepping to start late-stage clinical trials on a drug candidate that could treat low cardiac output syndrome and the company is tapping the cardiac surgery trials experience of the Duke Clinical Research Institute to do it.
The DCRI was selected by Oxygen Bio for the phase III trial on levosimendan, a drug that the Morrisville company acquired in its merger with New Jersey company Phyxius Pharma. That merger closed last month.
The intravenously administered levosimendan, which was discovered and developed by Finland-based Orion Pharma, is already approved in more than 50 countries for acute decompensated heart failure. With the close of the Phyxius merger, Oxygen now holds the rights to develop and commercialize the levosimendan in North America.
Oxygen is seeking approval for reduction of morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome, or LCOS. The Food and Drug Administration has granted “fast track” status on the drug, which expedites regulatory review of new addressing a serious need for which there is no other approved treatment.
There are currently no drugs treating LCOS. The phase III clinical trial will study if administering levosimendan before and during surgery will reduce the incidence of LCOS and associated morbidity and mortality.
Levosimendan is much further along in development than any of the compounds that Oxygen Bio had in its pipeline prior to the merger. Oxygen Bio’s lead drug candidate was Oxycyte, a compound in mid-stage clinical trials as treatment for traumatic brain injury. Oxycyte works by improving the delivery of oxygen to damaged tissue.
The DCRI will serve as the coordinating center for the levosimendan study. Drs. John H. Alexander and Rajendra Mehta will be investigators for the phase III trial. The FDA and Oxygen Bio have reached agreement that a single successful trial will be enough to support approval of levosimendan for the LCOS 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.