The U.S. Food and Drug Administration (FDA) has given Ischemix permission to begin human studies with CMX-2043, the company's new drug designed to protect the heart from damage associated with coronary artery bypass graft (CABG) operations. This novel compound includes both anti-oxidant and calcium regulating activities which act together to reduce ischemia-reperfusion injury.
Each year about half a million Americans undergo surgical procedures to provide a new blood supply when arterial blockage or narrowing starves the heart muscle of oxygen and essential nutrients. But complications are common and may include new heart attack, stroke and rhythm disturbances. In pre-clinical studies CMX 2043 has been shown to protect heart muscle and brain, and reduce the incidence of arrhythmia.
Ischemix's Investigational New Drug (IND) application included safety and efficacy data, and a protocol for the initial human studies. The FDA approved the application by letter today. This important milestone moves Ischemix from the research phase into clinical development of a drug responding to a major unmet medical need. The first-stage human studies are planned to begin within a month and are expected to continue for 3 months.