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Ischemix Announces Positive Top Line Data from Phase 2 Clinical Trial of CMX-2043


6/17/2011 7:56:44 AM

MAYNARD, Mass.--(BUSINESS WIRE)-- Ischemix today announced positive top line data from a Phase 2a clinical trial of CMX-2043 for the prevention of peri-operative cardiac ischemia-reperfusion injury. The trial achieved its primary endpoint of safety with CMX-2043 demonstrating a favorable safety profile at all doses, consistent with the Phase 1 data. Additionally, although the trial was not powered to show statistical differences in efficacy, CMX-2043 demonstrated positive trends in all secondary efficacy endpoints and achieved statistically significant benefits in a key endpoint measure of cardiac health. CMX-2043 is a cardio-protective drug candidate that combines Akt pathway-mediated cell survival effects and anti-oxidant activity in a single small molecule. Ischemix intends to submit detailed results from the CMX-2043 Phase 2a trial for presentation at an upcoming medical meeting.

“We believe that the Phase 2 safety and efficacy data for CMX-2043 are very promising. CMX-2043 represents a potential new approach to prevention of peri-operative ischemia-reperfusion injury, a field where previous drug candidates have not succeeded in clinical studies,” commented Duffy DuFresne, Chief Executive Officer of Ischemix.

About the Phase 2a Trial

The Phase 2a trial of CMX-2043 was a multi-center trial for the prevention of peri-operative ischemia-reperfusion injury in patients undergoing elective percutaneous coronary intervention at higher risk for peri-operative cardiac injury. This prospective, randomized, double-blind, placebo-controlled trial compared three intravenous dosing levels of CMX-2043. The primary endpoint of the study was safety assessment of CMX-2043 injection. Secondary outcomes evaluated the efficacy of CMX-2043 based on changes observed in biomarkers of cardiac injury, including CK-MB and Troponin T as well as continuous electrocardiographic monitoring.

About Ischemix

Ischemix is a privately-held drug discovery company with a portfolio of small molecule therapeutic compounds. The first of these compounds is targeted to reduce cell death and organ damage due to initial interruption and subsequent resumption of blood flow associated with cardiac surgeries and interventional procedures such as percutaneous coronary intervention ("PCI" or "angioplasty") and coronary artery bypass grafting ("CABG") as well as myocardial infarction ("MI" or heart attack). www.ischemix.com

Contact:

MacDougall Biomedical CommunicationsChris Erdman, 781-235-3060chris@macbiocom.com


Read at BioSpace.com

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