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Schering-Plough Starts Patient Enrollment in Phase 3 Trial for Acadesine, an Investigational Agent Being Studied for Prevention of Complications From Cardiac Surgery
Date:5/11/2009

RED-CABG Trial Initiates Patient Recruitment for Potentially Life-Saving Agent

KENILWORTH, N.J., May 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced the start of patient enrollment in RED-CABG, the Phase 3 Trial for acadesine, an investigational, potentially first-in-class adenosine regulating agent (ARA). Acadesine was licensed from PeriCor Therapeutics, Inc., a privately held specialty biopharmaceutical company. Acadesine is being studied as intravenous infusion for the prevention of ischemia-reperfusion injury, a complication of cardiac surgery in patients undergoing coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (a procedure that stops the heart and places the patient on a pump).

"Ischemia-reperfusion injury represents a serious and life-threatening cardiac surgery complication in patients undergoing coronary artery bypass surgery performed with cardiopulmonary bypass, and there are currently no approved treatments," stated Robert Harrington, M.D., Director of the Duke Clinical Research Institute, and Study Chair of the trial.

Although CABG surgical techniques have improved and reduced procedural morbidity and mortality, complication rates resulting from these procedures, such as ischemia-reperfusion injury, remain unacceptably high. According to a national cardiac surgery database from the Society of Thoracic Surgeons, there is a 30-day operative mortality and major complication rate of 13.4 percent associated with the CABG procedure. In addition, an agent that can be shown to reduce surgical complications can potentially have a significant impact on healthcare costs.

"We are pleased to be initiating the RED-CABG Phase 3 clinical trial for acadesine, which has the potential to reduce perioperative complications in patients un
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SOURCE Schering-Plough Corporation
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