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.
“It is inspiring that we now have initiated the study following extensive preparations. This is an important study that can contribute to improve the health of our patients. The collaboration between the clinic, the hospital’s research and development team and NeuroVive has been very successful,” commented Henrik Bjursten, Associate Professor and Senior Consultant at Skåne University Hospital and the principle investigator responsible for the study.
“There is a clear link between acute kidney injury during cardiac surgery and later medical conditions and death. This means that there’s an urgent need to try to prevent this kind of injury. In pre-clinical trials, the stabilizing effect of cyclophilin inhibitors on mitochondria has been shown to protect a number of different organs against injury resulting from insufficient blood flow. The problem often relates to the timely administration of the drug. In this respect, acute kidney injury during cardiac surgery presents a relatively unique scenario, as the procedure makes it possible to protect the kidneys and other organs before the altered blood flow occurs. This means that we have the ability to potentially protect organs also against the initial injury, not only against reperfusion injury,” commented Magnus Hansson, Senior Scientist at NeuroVive.
More information about the study is published in the public database ClinicalTrials.gov at: https://clinicaltrials.gov/ct2/show/NCT02397213
About mitochondrial protection of the kidneys during heart surgery
During cardiac surgery, the heart is usually connected to a heart-lung machine in order to enable surgical procedures such as heart valve repair or implantation of coronary artery bypass grafts. A heart-lung machine is used to oxygenate and pump blood through the body while the heart is disconnected. This means that heart surgery causes stress to the body as a whole, not just the heart, in the form of altered blood flow. There is a pressing need to protect high-energy demanding organs such as the kidneys from serious damage. This applies particularly to patients where renal function is already compromised prior to surgery and where the risk of complications is considered to be significant. The treatment is potentially suitable for all patients undergoing heart surgery using a heart-lung machine. In 2010, some 700,000 such surgeries were carried out in the US, and NeuroVive estimates a similar number for Europe. Consequently, there is a significant medical need and a market potential for a protective pharmacological treatment.
NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, is developing a portfolio of products to treat acute cardiovascular and neurological conditions through mitochondrial protection. These medical conditions are characterized by a pressing medical need and have no approved pharmaceutical treatment options at present. NeuroVive’s products CicloMulsion® (myocardial infarct) and NeuroSTAT® (traumatic brain injury) are currently being evaluated in phase III and phase II studies, respectively. NeuroVive’s research programs also include development of treatments against brain injury in stroke patients, and drug substances for cellular protection and treatment of mitochondrial disorders causing energy deficiency. NeuroVive’s shares are listed on NASDAQ OMX, Stockholm, Sweden.
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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 27 April 2015, at 8.30 a.m. CET.