SOURCE: Ischemix, Inc.

Ischemix, Inc.

September 30, 2015 10:43 ET

Ischemix, Inc. Completes Enrollment of Phase 2 Trial for Prevention of Acute Kidney Injury and Cardiac Injury in Cardiac Catheterization Patients

MAYNARD, MA--(Marketwired - September 30, 2015) - Ischemix, Inc., a clinical-stage pharmaceutical company focused on hospital-acquired kidney and cardiac injury, announced today that it has completed enrollment in its Phase 2 CARIN trial for prevention of contrast-induced acute kidney injury (CI-AKI) in patients entering the cardiac catheterization lab. Additionally, CARIN is designed to confirm Ischemix' previous successful Phase 2 results in the use of CMX-2043 for prevention of periprocedural cardiac injury in patients receiving cardiac stents (percutaneous coronary intervention or PCI). A total of 361 subjects have been enrolled in the CARIN trial. With the last subject enrolled completing follow-up in mid-December, complete data from the trial is projected to be available in the first quarter of 2016.

David A. DeWahl, Jr., President and CEO of Ischemix, said, "We are very grateful for the participation of the 31 sites in the US and Canada that enrolled subjects in the trial. We expect that receipt of successful results from the trial would enable us to secure the resources to continue our development plan for CMX-2043."

CARIN is a randomized, double-blind, placebo-controlled trial being conducted to assess the efficacy of CMX-2043 in the prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS) or non-ACS patients undergoing a high risk elective coronary angiography. The primary endpoint of the trial is the prevention of contrast-induced acute kidney injury (CI-AKI). Secondary endpoints include reduction in renal injury as determined by kidney biomarkers, incidence of major adverse cardiac events (MACE) or major adverse kidney events (MAKE) or other clinical complications, reduction in cardiac injury as determined by cardiac biomarkers and reduction in the incidence of Type 4a MI.

"CMX-2043, if ultimately approved for use in prevention of CI-AKI, would address a significant void in the critical care therapeutics marketplace," said Dr. Geoffrey E. Clark, Chief Medical Officer of the Company. "There are no drug therapies currently available to prevent or treat CI-AKI."

About Ischemix, Inc.

Ischemix is a privately-held pharmaceutical company developing novel cytoprotective compounds for the prevention and treatment of serious conditions of the kidney, heart and other organ systems. Ischemix' lead product candidate, CMX-2043, is a patented, new chemical entity based on a naturally-occurring compound. A potent cytoprotective agent, CMX-2043 enhances inherent protective mechanisms of the body, enabling cells to survive the challenges of impaired blood flow, drug treatments, and diagnostic contrast agents. Contrast agents are used in coronary angiograms to visualize obstructions or other defects in the patient's vasculature (a diagnostic procedure) or to aid in the placement of balloons or stents to open and maintain patency of blood vessels (a therapeutic procedure known as percutaneous coronary intervention or PCI). The iodine component found in all contrast agents is toxic to the cells of the kidney, therefore certain cardiac catheterization patients sustain CI-AKI from exposure to the contrast media.

Hospital-acquired acute kidney injury (HA-AKI) is estimated to afflict approximately three million patients and cause 700,000 deaths worldwide every year. In the US, at least 1.8 million hospitalized patients are diagnosed annually with HA-AKI at a cost of at least $10 billion. Approximately one million coronary angiographies and 600,000 PCIs are performed per year in the US, with CI-AKI occurring in an estimated 150,000 patients. The Company believes that if CMX-2043 is shown to be effective in preventing kidney injury due to contrast agents, it may also address other hospital-acquired impairment of renal function. There are currently no approved drug therapies for CI-AKI, HA-AKI or PCI-related cardiac injury.

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