Home ▸ News

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.

Latest News

August, 2023

Ischemix, Inc. Completes Successful Phase 1 Trial of Novel Compound to Treat Traumatic Brain Injury (TBI); Preparing for Conduct of Phase 2 Trial

July 7, 2021

Ischemix, Inc. Receives US Department of Defense Funding of $2.9 million to Conduct Phase 1 Study of Drug Candidate to Treat Traumatic Brain Injury (TBI)

March 25, 2019

Novel Compound for Treatment of Traumatic Brain Injury (TBI) Demonstrates Positive Results in a Preclinical Study

April 4, 2016

Ischemix Announces Results of Its Phase 2 CARIN Trial

January 5, 2016

Ischemix, Inc. to Present at Biotech Showcase™ on January 13, 2016

December 9, 2015

Ischemix, Inc. Announces First International Patent Coverage of Novel Analogs of its Lead Cytoprotective Compound

September 30, 2015

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

August 12, 2015

Ischemix Elects Peter G. Milner, MD to Board of Directors

May 19, 2015

Safety Review Committee for CARIN Trial recommends Phase 2a study to continue as planned

March 24, 2015

Ischemix Appoints Clinical Trial Liaison

June 26, 2014

Ischemix Enrolls First Patient in Phase 2a Trial to Prevent Contrast-Induced Acute Kidney Inury

January 9, 2013

Ischemix Appoints new Chief Executive Officer

June 17, 2011

Ischemix Completes Phase 2a Clinical Trial

March 2, 2011

Ischemix Granted Composition of Matter Patent for CMX-2043

March 9, 2010

Ischemix Initiates Phase 2a Clinical Trial

August 13, 2007

Ischemix Completes Phase 1 Clinical Trial

April 5, 2007

Ischemix Initiates Clinical Development