NeuroVive announces the CiPRICS study enrols 100 patients and reports favourable safety evaluation


NeuroVive Pharmaceutical AB (publ), the pioneers in mitochondrial medicine,
announces that the independent safety committee has once again endorsed the
continuation of the ongoing Phase II CiPRICS (Ciclosporin to Protect Renal
function In Cardiac Surgery) study, using NeuroVive’s product CicloMulsion®
against acute kidney injury.
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.

About NeuroVive
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

For investor relations and media questions, please contact:
Christine Tadgell, Tel: +46 (0)46 275 62 21 or ir@neurovive.com
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
info@neurovive.com, www.neurovive.com

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.
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 Pink 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/NE
V 
PF/quot)

Attachments

03133931.pdf
GlobeNewswire