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Ischemix Initiates Phase 2a Clinical Trial

March 9, 2010

Ischemix announced the initiation of patient accrual in a multi-center Phase 2a clinical trial of CMX-2043 for the prevention of peri-operative ischemia-reperfusion injury in patients undergoing elective percutaneous coronary intervention (PCI) procedures. CMX-2043 is a cardioprotective drug designed as a single dual action molecule with both calcium-regulating and anti-oxidant properties. The Phase 2a trial is a prospective, randomized, double-blind, placebo-controlled study that will compare three different intravenous dosing levels of CMX-2043. The primary outcome of the trial is the safety of CMX-2043 injection, as measured by biomarkers of cardiac damage; changes in Creatine-Kinase-MB (CK-MB) and troponin. Secondary outcomes will evaluate the efficacy of CMX-2043 based on changes observed in these cardiac biomarkers and via continuous electrocardiographic monitoring. The study will also explore the correlation between biomarker changes and the pharmacokinetics of the drug.