Duke University’s Duke Clinical Research Institute (DCRI) has been selected by Oxygen Biotherapeutics, a pharmaceutical company, to conduct the Phase III clinical trial of the company’s newly acquired compound, levosimendan.
For the Phase III trial, DCRI will serve as the coordinating center and Dr John H. Alexander and Dr Rajendra Mehta will act as lead investigators.
The double blind, randomized clinical trial has been designed to study if levosimendan administered before and during surgery will reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality.
The placebo controlled Phase III study will be conducted in approximately 50 major cardiac surgery centers in North America and will enroll up to 760 patients undergoing coronary artery bypass graphs (CABG) and/or mitral valve surgery who are at risk for developing LCOS.
Patient enrollment is expected to begin in the third quarter of 2014, and will take approximately 18 months to complete.
Levosimendan, a calcium sensitizer, was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland. Recently, Oxygen Biotherapeutics has acquired the North American rights from Phyxius Pharma to develop and commercialize levosimendan.
Levosimendan has been developed for intravenous use in hospitalized patients with acutely decompensated heart failure. Currently, this treatment is approved in more than 50 countries for acutely decompensated heart failure.
Oxygen Biotherapeutics CEO and Phyxius Pharma former co-founder John Kelley noted the company is extremely pleased to have an organization with the skill and expertise in conducting clinical trials that DCRI possesses as its partner.
"They have been responsible for managing a number of major cardiac surgery trials in the last decade, so their knowledge of this area of medicine is invaluable to us. At Phyxius Pharma, we worked with DCRI for the past three years to develop the clinical program for levosimendan.
"They played a key role in designing the Phase 3 protocol that has been approved by the FDA under SPA," Kelley added.
The compound has been granted fast track designation by the US Food and Drug Administration (FDA) for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing LCOS.
The FDA has agreed to the Phase III protocol design under Special Protocol Assessment. The agency also provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.
