SOURCE: Ischemix, Inc.

Ischemix, Inc.

May 03, 2016 12:50 ET

Ischemix Announces Results of Its Phase 2 CARIN Trial

MAYNARD, MA--(Marketwired - May 03, 2016) - Ischemix, Inc., a privately-held pharmaceutical company that has developed a portfolio of novel, safe and potent cytoprotective compounds for the prevention and treatment of serious diseases and conditions, today announced the results of the Company's recently completed Phase 2 CARIN trial. The CARIN trial (NCT02103959) was a randomized, double-blinded, placebo-controlled 361-subject Phase 2 study in which Ischemix' lead compound, CMX-2043, was studied for its ability to protect patients undergoing cardiac catheterization procedures against contrast-induced kidney injury (CI-AKI) and peri-procedural cardiac injury. The subjects in the trial received either placebo or CMX-2043 administered in one of three dose arms.

CMX-2043 was shown to be safe in this broad pool of patients and there were no drug-related serious adverse events. Although the trial did not meet the pre-specified endpoints of prevention of CI-AKI or peri-procedural injury, the Company is reviewing post hoc analyses of certain patient subgroups for evidence of potential benefit of the drug.

Ischemix' Chairman and Chief Scientific Officer, Reinier Beeuwkes, Ph.D., noted that "The results of the CARIN trial were disappointing given that in an previous Phase 2 trial in patients undergoing cardiac catheterization procedures, CMX-2043 demonstrated an ability to prevent peri-procedural cardiac injury. The compound had also shown efficacy in the prevention of CI-AKI in pre-clinical models. One possible limitation to the study was the dosing of CMX-2043. While the specific doses and regimens studied by the researchers did not yield any significant kidney protection, smaller, larger or more frequent doses may show such benefits."

Dr. Deepak L. Bhatt, Professor of Medicine, Harvard Medical School and Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart and Vascular Center, and the lead investigator for the trial, presented the results of the trial on April 4, 2016 at the annual meeting of the American College of Cardiology in Chicago, IL.

David A. DeWahl, Jr. President and CEO said, "We are continuing to analyze the results of the trial and are conducting additional pre-clinical studies to better understand the dosing dynamics that may have occurred in the CARIN trial. In addition, we are considering further pre-clinical study of CMX-2043 in indications in which it has previously shown signs of efficacy in pre-clinical models, which are prevention of drug-induced nephrotoxicity, prevention of delayed graft function in connection with kidney transplants and treatment of traumatic brain injury, stroke and shock."

The randomized, double-blinded clinical trial recruited 361 patients from 31 medical centers in the United States and Canada. Recruited subjects were previously scheduled for an angiogram with a high likelihood that they would need angioplasty because of a poor stress test or acute coronary syndrome. The subjects also had either a severe loss of kidney function or mild-to-moderate loss of kidney function and another risk factor such as diabetes, low blood pressure or being more than 75 years old. Patients experiencing a heart attack, life-threatening arrhythmia or total kidney failure were excluded.

Patients were split into four groups and intravenously given a small dose, a large dose or two small doses of CMX-2043 or a placebo before receiving contrast agent. Researchers followed the subjects over a period of 90 days, the primary endpoint being a reduction in kidney injury. The researchers also examined the incidence of major adverse cardiac and kidney events, reduction in heart damage and heart attacks, and major side effects of CMX-2043.

About Ischemix, Inc.

Ischemix is a privately-held, clinical-stage pharmaceutical company that has developed novel compounds for cytoprotection in the kidney, heart and other organ systems. There are currently no drugs approved for these indications. Ischemix' lead product candidate, CMX-2043, is a novel therapeutic agent based on a naturally occurring compound. CMX-2043 has been granted recent composition-of-matter patent in the US and other major jurisdictions around the world. CMX-2043 is a cytoprotective agent that activates endogenous pathways of cell survival.

Ischemix previously completed a randomized, double-blinded, placebo-controlled 142-patient trial of CMX-2043 for the prevention of cardiac injury in PCI patients. Subjects receiving the highest of the three doses of drug given in that trial had a statistically significant reduction in peri-procedural cardiac injury as measured by both of the standard biomarkers utilized to diagnose this condition.

Kidney injury caused by contrast media given during cardiac catheterization is associated with increased morbidity, mortality and health care resource consumption. This injury 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. The incidence of this injury progressing to renal failure and kidney dialysis has recently been increasing at 10% per year.

Injury to the heart arising during therapeutic cardiac catheterization (also called PCI or "stenting") and coronary artery bypass surgery (CABG) is a significant problem. There are approximately 600,000 PCIs and 400,000 CABG procedures in the US each year. Up to 16% of PCI patients, depending on the type of procedure being performed, are estimated to sustain a myocardial infarction (MI) during the procedure. As many as 20% of CABG patients suffer short- and long-term complications, including MIs.

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