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

[June 26, 2014]

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

MAYNARD, Mass. --(Business Wire)--

Ischemix, Inc., a pharmaceutical company developing a portfolio of cytoprotective compounds to address serious diseases, is pleased to announce that it has successfully enrolled the first patient in a Phase 2a trial of its lead compound to prevent contrast-induced acute kidney injury ("CI-AKI") in acute coronary syndrome patients undergoing coronary angiography (the "CARIN" trial). The Company's lead compound, CMX-2043, is a chemically-modified, naturally-occurring molecule with an excellent safety profile that has demonstrated efficacy in a prior human clinical trial.

"The CARIN trial presents an exciting opportunity to study the potential of CMX-2043 to treat cardiac patients who are at serious risk of complications," stated Dr. Deepak L. Bhatt, lead investigator of the CARIN trial. Dr. Bhatt is Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart & Vascular Cente, and Professor of Medicine at Harvard Medical School.

The CARIN trial will enroll 240 patients to study the ability of CMX-2043 to prevent CI-AKI. It is estimated that approximately 500,000 coronary angiography patients each year in the US are at high risk of developing CI-AKI. Overall, an estimated 7 to 10 million patients receive contrast media in the US each year. There are no drug therapies approved for CI-AKI. The CARIN trial will also seek to confirm the results of its prior Phase 2a trial in which CMX-2043 prevented peri-procedural cardiac injury in patients undergoing a percutaneous coronary intervention ("PCI (News - Alert)"). There are an estimated 600,000 PCI procedures in the US each year.

Ischemix estimates that data from the CARIN trial will be available in mid-2015, at which time the Company plans to initiate discussions with prospective corporate partners. Ischemix believes that CMX-2043 has the opportunity to address indications with in excess of a billion dollars of potential revenues, while producing a net cost savings to the health care system.

The Company

Ischemix, Inc. is a privately-held, clinical stage pharmaceutical company based in Maynard, MA. The Company is developing CMX-2043 and other cytoprotective compounds to prevent and treat injury to the heart, kidney and other vital organ systems. Ischemix believes that CMX-2043 and related compounds activate the Akt pathway to act as potent anti-oxidants and to interrupt the cycle of apoptosis and other pathophysiology resulting from the initial cell injury. Current pre-clinical development of the compounds is focused on traumatic brain injury, ischemic stroke and ophthalmic indications. CMX-2043 has previously completed a 40-patient Phase 1 trial and a 142-patient Phase 2a trial.

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