Patients included in the CiPRICS study are observed in the hospital after coronary artery bypass surgery (CABG) and then are subsequently followed up for 30 days. When all patients have completed follow-up and all assessment data have been collected, it will be analysed according to a pre-specified statistical analysis plan. The investigators expect to complete data analysis and communicate the CiPRICS study results during the fall of 2016. Two safety analyses have already been completed following the enrolment of 50 and 100 patients in the study. The CiPRICS safety evaluations have not found any concerns regarding the treatment’s safety profile.
“We have been working closely with the Department of Cardiothoracic Surgery research team at Skåne University Hospital and have been very pleased to see the CiPRICS study team’s enthusiasm and professional handling of the study. They have impressively managed to complete the study enrolment according to plan. Our clinical development programme in acute kidney injury is one of NeuroVive’s key priorities in 2016. If the results are positive they will provide further insights towards the development of both CicloMulsion® and NVP019 in this area of high unmet medical need," commented Magnus Hansson, NeuroVive’s Chief Medical Officer.
Acute kidney injury (AKI) may occur after major surgeries, such as CABG, which is performed annually in over 400,000 people worldwide. There are currently no approved preventive treatments for AKI. Patients suffering an AKI during CABG surgery are at risk of developing end stage renal disease, which is a serious and costly consequence requiring dialysis in a number of cases. There is growing interest both scientifically and commercially in AKI, as this is a both ominous and costly complication and a new treatment options for these patients is needed.
NeuroVive Pharmaceutical AB (publ) is a pioneer in mitochondrial medicine and a company committed to the discovery and development of highly targeted candidates that preserve mitochondrial integrity and function in areas of significant therapeutic need. NeuroVive’s business approach is driven by value-adding partnerships with mitochondrial research institutions and commercial partners across the globe. NeuroVive’s portfolio consists of two clinical projects in acute kidney injury (AKI) and traumatic brain injury (TBI) with candidates in clinical and preclinical development and two drug discovery platforms. The NeuroSTAT® product has orphan drug designation in Europe and in the US for treatment of moderate to severe traumatic brain injury and is currently being evaluated in the CHIC study. Ciclosporin (CicloMulsion®) is being evaluated in an on-going study, CiPRICS, in acute kidney injury during major surgery. NeuroVive’s shares are listed on Nasdaq, Stockholm, Sweden.
More information about the CiPRICS study
The CiPRICS study (Ciclosporin to Protect Renal function In Cardiac Surgery) is a double-blind, randomized and placebo-controlled clinical Phase II study including a total of 150 patients. The patients are being treated with ciclosporin or placebo in connection with coronary artery bypass surgery (CABG) at the Department of Cardiothoracic Surgery at Skåne University Hospital in Lund, Sweden. The study is investigator-initiated and is conducted by Skåne University Hospital with support from NeuroVive which is providing the investigational product, CicloMulsion® and placebo. In addition to the predefined safety analyses, the safety profile of the treatment is evaluated continuously. More information about the study has been published in the public database ClinicalTrials.gov at: https://clinicaltrials.gov/ct2/show/NCT02397213
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NeuroVive Pharmaceutical AB (publ) is required to publish the information in this news release under The Swedish Securities Market Act. The information was submitted for publication on the 7th June 2016, at 08.30 CET.