Ischemix Initiates Phase 2a Trial Of CMX-2043 For The Prevention Of Ischemia-Reperfusion Injury

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Heart Disease
Article Date: 11 Mar 2010 - 0:00 PDT

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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 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," 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.

About Ischemia-Reperfusion Injury

"Ischemia" refers to insufficient blood flow to living cells or organs due to complete or partial blockage of the blood vessels to the area, resulting in cell death. "Reperfusion" refers to restoration of blood flow to an organ or tissue following an ischemic event. Cardiac surgeries and interventional procedures that open blocked arteries to restore blood flow may temporarily increase ischemia, and paradoxically result in "reperfusion injury," which can exceed the original ischemic damage or cell death. Thus, the sequence of events is known as "ischemia-reperfusion" injury.

About CMX-2043

CMX-2043 is a cardio-protective drug that combines cell survival and anti-oxidant activity in a single dual-action small molecule. The compound is designed to activate the Akt cell protective pathway, thereby limiting unnecessary cell death. A Phase 1 double-blind, escalating-dose clinical trial in healthy volunteers showed no evidence of treatment-related adverse events at doses up to five times those anticipated to be effective in cardiac surgery patients. In addition, preclinical studies have demonstrated the compound's effectiveness as a protective agent in a model of cardiac ischemia-reperfusion injury, as well as its effectiveness when administered as a single intravenous dose before artery blockage (protection for cardiac surgery); during blockage (unexpected heart attack); and before reperfusion (stenting).

Source
Ischemix

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