Date: 2016-10-13
Type of information: discontinuation of development
phase: 2
Announcement: discontinuation of development
Company: NeuroVive Pharmaceutical (Sweden)
Product: CicloMulsion® (Cremophor®-free intravenous 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. By protecting a cell's mitochondria, NeuroVive's products ensure that energy production is preserved and a damaged cell's normal regenerative mechanisms can act to repair and maintain the cell.
Disease: acute kidney injury
Therapeutic area: Kidney diseases - Renal diseases
Country: Sweden
Trial
details: The CiPRICS (Ciclosporin to Protect Renal function In Cardiac Surgery) study is a double-blind, randomized and placebo-controlled clinical phase II study. The study will include a total of 150 patients at the department of Cardiothoracic Surgery at Skåne University Hospital in Lund, which also initiated the study. Patients will be treated with CicloMulsion® or placebo prior to coronary bypass surgery. The aim is to evaluate whether pre-treatment with a mitochondria-protecting drug protects the kidneys against injury and prevents the compromised renal function that can result from altered blood supply during cardiac surgery. In addition to the patients’ renal function, which will be closely monitored, other markers, such as markers for cardiac injury, will be analyzed. Henrik Bjursten, Associate Professor and Senior Consultant at Skåne University Hospital is the principle investigator responsible for the study. (NCT02397213)
Latest
news: * On October 13, 2016, NeuroVive Pharmaceutical announced results from the exploratory clinical phase II study CiPRICS. The results clearly show that patients treated with CicloMulsion prior to open heart surgery experience no benefit compared to placebo in the prevention of acute kidney injury. As a result, NeuroVive will discontinue the development of CicloMulsion for acute kidney injury. The exploratory CiPRICS study, aimed at preventing acute kidney injury in patients undergoing open heart surgery, did not reach the primary objective. In contrast, patients in the active dose group showed a transient, but statistically significant increase in the biomarkers P-cystatin C and P-creatinine compared to placebo. No unexpected tolerability issues were observed and the overall frequencies of serious adverse events were comparable to those observed in the placebo group. Given the current findings, NeuroVive has decided to discontinue the development of CicloMulsion in acute kidney injury and redirect resources to its other development assets. NeuroVive continues to progress its opportunities within mitochondrial medicine, an area with high unmet medical needs. The ciclosporin (NeuroSTAT) development program in traumatic brain injury (TBI) will proceed. NeuroVive will continue development of its unique non-Ciclosporin based cyclophilin inhibitors for organ protection and other unrelated indications. * On April 27, 2015, NeuroVive Pharmaceutical announced that the first patient has been enrolled in a clinical phase II study for acute kidney injury using the company’s product CicloMulsion®. The study, known as CiPRICS, is being conducted by Skåne University Hospital and will evaluate the product’s ability to prevent acute kidney injury during heart surgery.
* On November 19, 2015, NeuroVive Pharmaceutical announced that the independent safety committee has endorsed the continuation of the on-going Phase II CiPRICS (Ciclosporin to Protect Renal function In Cardiac Surgery) study following the enrolment of the first 50 patients in the study. The assessment is conducted in order to evaluate the treatment’s safety profile. On the basis of 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 about 60 patients to date and is progressing as planned. The study is a proof of concept study for the prevention of acute kidney injury (AKI) in patients undergoing major surgery AKI and further studies will be required in order to advance the NeuroVive clinical development program in this area.
