News | April 22, 2011

First Heart Attack Patient Treated in European Cardioprotection Phase III Trial

April 22, 2011 – The first patient has been treated in a European multicenter CIRCUS trial. The study is looking at NeuroVive Pharmaceutical’s CicloMulsion cremophor-free IV cyclosporine formulation in 1,000 patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction.

The goal is to examine cyclosporine's ability to protect cardiac tissue. The double-blind, placebo-controlled, investigator-initiated study is being led by trial sponsor Professor Michel Ovize, M.D., Ph.D., of Hospices Civils de Lyon (HCL). NeuroVive is supporting the study by providing active drug, placebo and drug logistics. The study will enroll patients at 40 centers in France and additional European sites.

"Patients with myocardial infarction often undergo emergency percutaneous coronary intervention in which a catheter passed through the major blood vessels restores blood flow to blocked coronary arteries,” Ovize said. “Even after blood flow is restored, damage to the heart muscle continues to progress through what is known as reperfusion injury. Small-size proof-of-concept studies have shown that reperfusion injury may account for as much as 30-40 percent of total infarction-related myocardial damage and that timely therapeutic interventions can prevent this damage. From a clinical point of view, it is critical to develop a drug to protect cardiac tissue during PCI and hopefully improve clinical outcome."

"If efficacy is proven, NeuroVive´s CicloMulsion, a safe formulation of cyclosporine, should become an important new treatment for heart patients and reduce morbidity and mortality after myocardial infarction,” said NeuroVive´s CEO Mikael Bronnegard. “In addition, it will deliver a major reduction in the social and economic burden of heart disease and target a significant and growing global market of patients with cardiovascular disease."

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