Date: 2015-08-31
Type of information: discontinuation of development
phase: 3
Announcement: discontinuation of development
Company: NeuroVive Pharmaceutical (Sweden) Hospices Civils de Lyon (France)
Product: CicloMulsion® cremophor-free IV cyclosporine formulation
Action
mechanism: immunosuppressive agent. The active ingredient cyclosporine acts by preventing the death of mitochondria in damaged cells and the following cascade of intracellular biochemical events that lead to secondary tissue damage.
Disease: myocardial infarction
Therapeutic area: Cardiovascular diseases
Country: Belgium, France, Spain
Trial
details: The CIRCUS clinical trial (does Cyclosporine ImpRove Clinical oUtcomes in ST elevation myocardial infarction patients?) is an "investigator-initiated trial," defined as undertaken as an independent scientific research initiative by the clinical trial investigator and not at the behest of the pharmaceutical developer or industry. NeuroVive is supporting the study by providing drug and placebo. In total, about 1,000 patients will be entered in the trial. The impact of cyclosporine will be evaluated against a number of objective clinical parameters, including left ventricular function, blood markers of myocardial infarction, quantitative assessment of myocardial infarction size, and clinical status of the patient after completion of PCI. The enrollment period is planned for 18 months with a 12-month follow-up period for each patient. (NCT01502774)
Latest
news: * On June 1, 2015, NeuroVive Pharmaceutical reports that the phase III CIRCUS study of CicloMulsion® in patients with a specific type of heart attack known as ST-segment elevation acute myocardial infarction (STEMI) did not meet its primary clinical endpoint in a topline analysis. The topline analysis of the study data provides information on whether the primary endpoint has been met or not. This result does not contain specific data concerning the level of significance for either the composite endpoint or each individual element of the composite endpoint. These will be revealed in the subsequent detailed analysis. It is anticipated that the full results of the 12-month data from the CIRCUS study will be made available in the third quarter. Today’s topline result is expected to delay the commercialization of CicloMulsion®. The primary endpoint is a composite of three separate outcomes: mortality, hospitalization for heart failure and left-ventricular (LV) remodeling at 12 months post acute myocardial infarction. The primary objective of the study was to determine whether CicloMulsion® can improve STEMI patient clinical outcomes 12 months after administration. CicloMulsion® or placebo was administered directly prior to percutaneous coronary intervention (PCI), a common procedure to reopen the coronary artery allowing the return of blood flow to the heart. The study will continue for a further two years to investigate longer term outcomes. CicloMulsion® is an investigational product and has not been approved by regulatory agencies for the treatment of any medical condition. The impact of the CIRCUS results on the future development of CicloMulsion® will be communicated in the second half of 2015. * On April 19, 2011, NeuroVive Pharmaceutical and Hospices Civils de Lyon have announced the enrollment and treatment of the first patient in the European multicenter trial of myocardial infarction (the CIRCUS study). NeuroVive's advanced CicloMulsion® cremophor-free IV cyclosporine formulation is used in this study of 1,000 patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction 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. 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.* On August 31, 2015, Neurovive Pharmaceutical announced that it will not pursue development of CicloMulsion® in the indication of acute myocardial infarction (AMI). The company will now place strategic focus on progressing the research and development activities of CicloMulsion® in acute kidney injury, the development of its other drug candidates as well as accelerating its discovery programs. This decision follows the data presentation from the investigator-initiated Phase III CIRCUS study of CicloMulsion® in patients with a specific type of heart attack known as ST-segment elevation myocardial infarction (STEMI) at the European cardiology meeting in London, UK. The data presented showed that CicloMulsion® had no therapeutic effect on AMI patients undergoing PCI (percutaneous coronary intervention). However, the CIRCUS study confirmed the safety profile of CicloMulsion®. NeuroVive remains committed to the Phase II CiPRICS study of CicloMulsion® in pretreatment of acute kidney injury during major surgery, as well as the Phase II CHIC study of NeuroSTAT® in traumatic brain injury. CicloMulsion® is one of several investigational products in clinical and preclinical development.
* On February 17, 2014, NeuroVive Pharmaceutical, a mitochondrial medicine company, has reported that the last of a total of 972 patients have now been enrolled and treated in its ongoing European phase III trial (CIRCUS), in which half of patients received the company’s pharmaceutical CicloMulsion® for treating reperfusion injury coincident with myocardial infarction. The final patient was enrolled and treated in the study on 16 February, and the trial will now be followed up for a one-year period, as it finally closes for data analysis.
