Ischemix Announces That Safety Review Committee For CARIN Trial Recommends Phase 2a Study To Continue As Planned

MAYNARD, Mass.--(BUSINESS WIRE)--Ischemix, Inc. announced today that it has received a favorable safety report from the Safety Review Committee for the ongoing CARIN (contrast-induced acute kidney injury (“CI-AKI”) in acute coronary syndrome patients undergoing coronary angiography) trial. On behalf of the committee, Ahmad Kahlil MD, Medical Monitor for the trial, made his formal report to Ischemix, the Sponsor of the trial, that the study is recommended to continue as planned. There were no signals of concern noted.

“The report by the Safety Review Committee is consistent with the results of our two previous clinical trials, in which CMX-2043 was shown to be safe and well tolerated at therapeutic dose levels.”

The CARIN trial is a randomized, double-blinded, placebo-controlled trial of Ischemix’ lead compound, CMX-2043, for the prevention of contrast-induced acute kidney injury (CI-AKI) and cardiac injury in cardiac catheterization patients. Ischemix’ previous Phase 2a trial successfully demonstrated the latter endpoint; the CARIN trial is also designed to confirm these results. To date the CARIN trial has enrolled 212 patients at 28 sites in the US and Canada.

Ischemix CEO David A. DeWahl, Jr. commented “The report by the Safety Review Committee is consistent with the results of our two previous clinical trials, in which CMX-2043 was shown to be safe and well tolerated at therapeutic dose levels.” CMX-2043 is a new chemical entity based on a naturally-occurring compound. Ischemix holds recently issued composition-of-matter patents covering its portfolio of compounds.

The Safety Review Committee completed the planned review of the safety data on the first 150 subjects completing the 72-hour follow-up in the trial. Due to the timing of enrollment, the data for 156 subjects were reviewed. Data reviewed was limited to the reported adverse events and data submitted from the local laboratories.

About Ischemix, Inc.

Ischemix is a privately-held, clinical-stage pharmaceutical company developing novel cytoprotective compounds for the prevention and treatment of serious diseases and conditions. The initial focus of the Company is the prevention of acute kidney injury and cardiac injury in patients undergoing cardiac catheterization procedures. Ischemix’ lead product candidate, CMX-2043, is a patented, new chemical entity based on a naturally-occurring compound. CMX-2043 is currently conducting a Phase 2a trial to study the prevention of contrast-induced acute kidney injury (CI-AKI) in cardiac catheterization patients and to prevent cardiac injury in patients undergoing PCI. The results of the Company’s previous Phase 2a trial successfully demonstrated the latter endpoint; CARIN is also designed to confirm these results.

CI-AKI is diagnosed in at least 150,000 patients in the US annually and is associated with increased morbidity, mortality and health care costs. CI-AKI is a major category of hospital-acquired acute kidney injury (HA-AKI), which is estimated to afflict 1.8 to 3.5 million hospitalized patients in the US and to cost the health care system at least $10 billion annually. The Company believes that if CMX-2043 is shown to be effective for CI-AKI, it may also address HA-AKI. Cardiac injury during PCI is also associated with increased morbidity and mortality. There are currently no approved drug therapies for CI-AKI, HA-AKI or PCI-related cardiac injury.