NeuroVive and Skåne University Hospital initiate collaboration on clinical phase II study on kidney protection during heart surgery

NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, has
initiated a collaboration with Skåne University Hospital to complete a clinical
phase II study on the evaluation of the company’s product CicloMulsion®
regarding its ability to prevent acute kidney injury in 150 patients undergoing
heart surgery. Enrolment to the study will begin in the first half of 2015 and
is expected to continue until the end of 2016.
NeuroVive’s product CicloMulsion® is already being evaluated in clinical studies
focusing on protecting the heart and brain in connection with acute injury
(known as NeuroSTAT® for brain protection). Drugs that protect the mitochondria
also have significant potential to protect high-energy organs like the kidneys
during surgery. Two clinical studies have shown that the active substance is
safe for heart surgery and provides protection against diffuse injury*. This has
led Skåne University Hospital to initiate a clinical study to evaluate the
potential for protecting the kidneys using CicloMulsion® in cardiac surgery.

The study is known as CiPRICS (Ciclosporin to Protect Renal function In Cardiac
Surgery) and is a double-blind, randomized and placebo-controlled clinical phase
II study to include a total of 150 patients. The patients will be treated with
CicloMulsion® in connection with coronary artery bypass surgery at the Clinic
for Cardiothoracic Surgery at Skåne University Hospital in Lund, Sweden. The
study is investigator-initiated and is conducted with support from NeuroVive.

“Acute kidney injury is a serious problem that has received increasing attention
in recent years. We know that patients who suffer from a transient reduction in
renal function in connection with heart surgery have a poorer prognosis, and
there are currently no preventive treatments available. Cyclosporin-A, the
active substance in CicloMulsion®, is very promising in this context. What’s
unique about our study is that we’ll focus specifically on patients with the
highest risk of kidney injury and will monitor renal function very closely in
the days following surgery. We’re very pleased to be collaborating with
NeuroVive, which enables us to conduct this important study” commented Henrik
Bjursten, Associate Professor and Senior Consultant at Skåne University Hospital
and the researcher responsible for the study.

“The CiPRICS study meets a pressing medical need and is also another step
towards evaluating new indications for our cyclophilin inhibitor CicloMulsion®
and the forthcoming product NVP019. This means that we take a very positive view
of this collaboration with Skåne University Hospital. The prevention of acute
kidney injury during heart surgery is a promising indication, as we’d be able to
pre-treat patients and our drug candidates would be present throughout the
period organs are exposed to altered blood supply” commented NeuroVive’s CEO
Mikael Brönnegård.

About mitochondrial protection of the kidneys during heart surgery
During cardiac surgery, the heart is usually stopped during surgery to enable
procedures such as heart valve repair or coronary artery bypass grafts. A heart
-lung machine is used to oxygenate and pump blood to the body while the heart is
stopped. This means that heart surgery causes stress to the body as a whole, not
just the heart, in the form of altered blood flow, and there is a pressing need
to protect high-energy 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 the greatest.
The treatment is potentially suitable for all patients undergoing heart surgery
using a heart-lung machine. In 2010, some 700,000 such surgeries were completed
in the US, and NeuroVive estimates that the figure for Europe is similar. In
other words, there is extensive medical need and market potential for the
treatment.

*). Hausenloy DJ et al. Heart 2014;100:544–9 & Chiari P et al. Anesthesiology.
2014;121:232-8

Current status of NeuroVive’s projects and drug candidates

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CicloMulsion®
NeuroVive’s product CicloMulsion® is the first cyclophilin inhibitor developed
for the treatment of reperfusion injury. The product’s potential in the
treatment of myocardial infarction is currently being evaluated in a clinical
phase III study. The last of a total of 972 patients was enrolled on 16 February
2014. The results of the study are due to be announced in 2015 following the
completion of the one-year follow-up of all patients and the analysis of the
study data. CicloMulsion will also be evaluated in a number of clinical phase II
studies for the treatment of other acute heart and kidney injury within the
framework of the collaboration with Hospices Civils de Lyon and Skåne University
Hospital in Lund, Sweden.

NeuroSTAT®
NeuroVive is developing NeuroSTAT® for the treatment of patients with moderate
or severe traumatic brain injury. NeuroSTAT® is currently being evaluated in a
clinical phase IIa study at Copenhagen University Hospital. The study focuses on
safety and pharmacokinetics, and 8 of 20 planned patients have been enrolled so
far. A phase III study is currently being planned and designed. NeuroVive has
secured orphan drug designation for NeuroSTAT® for moderate and severe traumatic
brain injury in the US and EU, which implies market exclusivity for seven years
in the US and ten years in the EU, from the date NeuroVive obtains market
authorization.

NVP019
NVP019 is NeuroVive’s primary drug candidate in the company’s new portfolio of
potent cyclophilin inhibitors belonging to a family of molecules known as
Sangamides based on a new and unique polyketide engineering technology. NVP019s
being developed as the next generation cyclophilin inhibitor for reperfusion
injury in heart attack, but also for other acute conditions where general
protection of vital organs is central to counteracting the progression of the
disease. An intravenous formulation will be evaluated for this purpose in
collaboration with external parties such as Hospices Civils de Lyon within the
framework of the OPeRa program.

NVP018
NVP018 is an oral formulation based on the same active substance as NVP019. It
has been developed for treatment of Hepatitis B and was outlicensed to OnCore
Biopharma (www.oncorebiopharma.com) in September 2014.

Other products
More information about all products developed by NeuroVive can be found at
http://www.neurovive.se/index.php/en/research-development/research-overview

About NeuroVive Pharmaceutical
NeuroVive Pharmaceutical AB (publ), a leading 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®
(heart attack) and NeuroSTAT® (traumatic brain injury) are currently being
evaluated in phase III and phase II studies, respectively. NeuroVive’s research
programs also include products for the treatment of brain cell injury in stroke
patients, and drug candidates for cellular protection and treating mitochondria
-related energy regulation diseases. 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 2 December 2014, at 8.30 a.m. CET.
NeuroVive Pharmaceutical AB (publ) - the mitochondrial medicine company.
NeuroVive 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)