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March 22, 2013 /PRNewswire/ --
NeuroVive, a leading mitochondrial medicine company, announces that the 600th patient has been recruited to a pivotal Phase III European, multi-center trial (CIRCUS trial) assessing CicloMulsion® (a special formulation of cyclosporine for acute cardiac injuries) for the treatment of heart reperfusion injury following stenting in patients with myocardial infarction.
The CIRCUS trial (does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients) is assessing CicloMulsion® in a study of nearly 1,000 patients undergoing stenting following acute myocardial infarction to examine its ability to protect cardiac tissue and improve clinical outcome. CicloMulsion® is a Cremophor®-free formulation of the cyclophilin inhibitor, cyclosporine, under clinical development by NeuroVive for the treatment of cardiac reperfusion injury.
In 2008 a 58 patient study published in the New England Journal of Medicine (NEJM, 2008 Jul 31; 359 (5): 473-81) showed cyclosporine, when administered immediately prior to stenting, could reduce reperfusion injury by 40% in patients with myocardial infarction. The CIRCUS trial is designed to confirm these results in a much larger patient group.
The trial is a multicentre, randomized, placebo-controlled, double-blind, investigator-initiated study. Patients receive one single injection of CicloMulsion® (or placebo) prior to reperfusion therapy by stenting. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodelling) is then assessed one year after treatment to determine whether cyclosporine can improve ST Elevation acute Myocardial Infarction (STEMI) patient clinical outcome. The study also includes a number of secondary outcome measures designed to provide a more detailed insight into CicloMulsion's ability to reduce a patient's level of cardiac injury following stenting.
The trial is being led by trial sponsor Professor
Michel Ovize, MD, PhD, of the University Hospital in
Lyon (HCL), a leading expert in the field of cardiovascular medicine and it is conducted by a CRO unit within the hospital according to good clinical practice (GCP) guidelines. The study is enrolling patients at centres in
France and additional sites in
Spain and is being funded by a number of European grant and public funding bodies. NeuroVive is supporting the study by providing active drug, placebo and drug logistics.
NeuroVive and HCL have recently agreed terms for the commercial use of the CIRCUS trial data which it expects to report in early 2015. If successful, NeuroVive intends to use these data as part of a planned marketing authorization application with the EMA.