NeuroVive has announced the 600th patient has been recruited to its pivotal Phase III European, multicentre trial (CIRCUS trial), which is assessing CicloMulsion for the treatment of heart reperfusion following injury during percutaneous coronary intervention.
According to a company press release, 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 that 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, randomised, 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, hospitalisation 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 Michel Ovize, of the University Hospital in Lyon, a leading expert in the field of cardiovascular medicine. The study is enrolling patients at centres in France and additional sites in Belgium and 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.
Michel Ovize commented: “Reperfusion injury following stenting is affecting a growing global patient population suffering from cardiovascular disease. This group represents a huge medical need and one for which there are currently no approved pharmaceutical treatment options available. It is therefore critical to develop a drug to protect cardiac tissue following stenting. Cyclosporine has already shown the potential to reduce significantly the level of reperfusion injury and we are looking forward to confirming this important finding in the current CIRCUS study.”