Ischemix News

Ischemix Completes Phase 2a Clinical Trial
June 17, 2011

Ischemix announced positive 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. 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. The Prospective, Randomized (3:1), Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1) enrolled patients at investigational sites throughout the United States and India.

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Ischemix Granted Composition of Matter Patent for CMX-2043
March 2, 2011

Ischemix was granted US 7,928,067 B2 patent entitled “Compositions and Methods for Treating Ischemia and Ischemia-reperfusion Injury” with a priority date of May 2009. Claims include composition of matter for CMX-2043 drug substance, drug product and pro-drugs. CMX-2043 was used in a Phase 2a clinical trial for the prevention of peri-operative ischemia-reperfusion injury in patients undergoing elective percutaneous coronary intervention (PCI) procedures.

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Ischemix Initiates Phase 2a Clinical Trial
March 9, 2010

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 cardioprotective drug designed as a single dual action molecule with both calcium-regulating and anti-oxidant properties. 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 biomarkers of cardiac damage; changes in Creatine-Kinase-MB (CK-MB) and troponin. 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.

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Ischemix Completes Phase 1 Clinical Trial
August 13, 2007

Ischemix, a privately held pharmaceutical company has completed Phase 1 Human Safety Studies of its drug candidate, CMX-2043. This double-blind escalating-dose 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. Based on this excellent safety profile, the company is now moving forward into studies in cardiac surgery patients.

CMX-2043 clinical development is initially targeted at prevention of complications associated with Coronary Artery Bypass Graft (CABG) surgery. Although CABG surgery is routine and performed approximately 500,000 times per year in the US, many patients have a significant complication after the procedure. The cost of such complications can be tens of thousands of dollars in extra procedures, ICU, and hospital stay per patient.

Ischemix is located in Maynard, MA. Its capabilities include chemical synthesis and analysis laboratories as well as facilities for cell culture and biological research. The company has contractual relationships with synthetic, analytical, manufacturing, preclinical and clinical organizations across the United States and in India.

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Ischemix Initiates Clinical Development
April 5, 2007

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.

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