A second safety analysis has been completed by an independent safety committee following the enrolment of 100 patients in the CiPRICS study. The first safety assessment was conducted after the first 50 patients were enrolled. Both safety assessments are conducted in order to evaluate the treatment’s ongoing safety profile and allow continuation of patient enrolment in the study. On the basis of these satisfactory safety findings, the study will continue as planned with the goal to enrol 150 patients and complete the study in the second half of 2016. The CiPRICS study has enrolled 106 patients to date and is progressing as planned.
Acute kidney injury (AKI) may occur after major surgeries, such as coronary artery bypass surgery (CABG), which is performed in over 400,000 people worldwide. There are currently no approved AKI treatment options available and patients with AKI during CABG surgery risk 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 based on the need to provide new treatment options for these patients.
“Our clinical development programme in acute kidney injury is one of NeuroVive’s key priorities in 2016 so we are naturally very pleased to see the study progress at a good speed and with satisfactory safety results. We are even more confident that the study will be completed and have the results available in the second half of 2016," commented Jan Nilsson, NeuroVive Chief Operating Officer.
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 status in Europe and in the US for treatment of moderate to severe traumatic brain injury and is currently being evaluated in a study, CHIC. 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®. 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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It is also possible to arrange an interview with NeuroVive’s COO Jan Nilsson at the above contacts.
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard), Fax: +46 (0)46 888 83 48
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 14 March 2016, at 08.30 CET.