Ischemix commences CMX-2043 Phase 2a trial for prevention of peri-operative ischemia-reperfusion injury

Mar 9 2010

Ischemix today 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 cardio-protective drug that combines Akt pathway-mediated cell survival effects and anti-oxidant activity in a single small molecule.

“This year approximately 500,000 Coronary Artery Bypass Graft surgeries will be performed, and about 700,000 patients will undergo a PCI procedure, and many of these patients will experience significant ischemia-reperfusion injury”

“This year approximately 500,000 Coronary Artery Bypass Graft surgeries will be performed, and about 700,000 patients will undergo a PCI procedure, and many of these patients will experience significant ischemia-reperfusion injury,” said Duffy DuFresne, CEO of Ischemix. “Despite this large number of affected patients, there is unfortunately no approved drug available to protect against this injury. Based on an excellent safety profile demonstrated in the Phase 1 trial, Ischemix is pleased to advance CMX-2043 into Phase 2a evaluation, moving it closer to potentially being the first therapy to address this significant medical issue.”

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 changes in Creatine-Kinase-MB (CK-MB) and troponin, biomarkers of cardiac damage. 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.