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 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.