Definitions

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Phase 1:

Initial studies in human volunteers to establish the safe dose level of a drug.

Phase 2:

“Proof of Concept” clinical studies in relevant patient populations.

CMX-2043

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Ischemix's most advanced drug candidate in their pipeline, CMX-2043, is a dual-action molecule. The cytoprotective compound is designed to block oxidative damage and activate cell survival pathways.

CMX-2043 is effective in preclinical studies when administered as a single intravenous dose before artery blockage (such as protection for cardiac surgery); during blockage (unexpected heart attack); and before reperfusion (stenting).

Phase 1 human safety studies have shown CMX-2043 to be safe at levels in excess of the therapeutic dose for efficacy in PCI, CABG and other cardiac surgical procedures.

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” or “angioplasty”) procedures was conducted. 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. CMX-2043 demonstrated positive trends in all secondary efficacy endpoints of myocardial injury defined by the post-procedural rise in the cardiac biomarkers CK-MB and Troponin T, and achieved statistically significant benefits in a key endpoint measure of cardiac protection.