First patient enrolled in clinical phase II study for kidney protection during heart surgery

NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company,
announces 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.
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.

About NeuroVive
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.

For Investor Relations and media questions, please contact:
Ingmar Rentzhog, Laika Consulting, Tel: +46 (0)46 275 62 21 or ir@neurovive.se
It is also possible to arrange an interview with NeuroVive’s CEO Mikael
Brönnegård or COO Jan Nilsson at the above contact.

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
info@neurovive.se, www.neurovive.se

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.
NeuroVive Pharmaceutical AB (publ) - the mitochondrial medicine company. The
company is listed on NASDAQ OMX Stockholm, Small Cap, under the ticker symbol
NVP. The share is also traded on the OTC market in the US. NeuroVive
Pharmaceutical (OTC: NEVPF) trades on the OTC Grey Market. Investors can find
Real-Time quotes and market information for the company
at www.otcmarkets.com/stock/NEVPF/quote (http://htt://www.otcmarkets.com/stock/N
E 
VPF/quot)