Schering-Plough Starts Patient Enrollment in Phase 3 Trial for Acadesine, anInvestigational Agent Being Studied for Prevention of Complications FromCardiac Surgery
Mon, 05/11/2009 - 4:41am
KENILWORTH, N.J., May 11 /PRNewswire-FirstCall/ -- Schering-PloughCorporation (NYSE: SGP) today announced the start of patient enrollment inRED-CABG, the Phase 3 Trial for acadesine, an investigational, potentiallyfirst-in-class adenosine regulating agent (ARA). Acadesine was licensed fromPeriCor Therapeutics, Inc., a privately held specialty biopharmaceuticalcompany. Acadesine is being studied as intravenous infusion for theprevention of ischemia-reperfusion injury, a complication of cardiac surgeryin patients undergoing coronary artery bypass graft (CABG) surgery usingcardiopulmonary bypass (a procedure that stops the heart and places thepatient on a pump). "Ischemia-reperfusion injury represents a serious and life-threateningcardiac surgery complication in patients undergoing coronary artery bypasssurgery performed with cardiopulmonary bypass, and there are currently noapproved treatments," stated Robert Harrington, M.D., Director of the DukeClinical Research Institute, and Study Chair of the trial. Although CABG surgical techniques have improved and reduced proceduralmorbidity and mortality, complication rates resulting from these procedures,such as ischemia-reperfusion injury, remain unacceptably high. According to anational cardiac surgery database from the Society of Thoracic Surgeons, thereis a 30-day operative mortality and major complication rate of 13.4 percentassociated with the CABG procedure. In addition, an agent that can be shownto reduce surgical complications can potentially have a significant impact onhealthcare costs. "We are pleased to be initiating the RED-CABG Phase 3 clinical trial foracadesine, which has the potential to reduce perioperative complications inpatients undergoing CABG surgery," Enrico Veltri, M.D., Group Vice President,Global Clinical Research, Cardiovascular and Metabolic Diseases,Schering-Plough Research Institute. "Schering-Plough is committed toaddressing the significant unmet medical need in ischemia-reperfusion injuryin this patient population," he added.