NeuroVive announces CiPRICS study completes enrolment


Lund, Sweden, 7 June 2016 – NeuroVive Pharmaceutical AB (publ), announces that
the CiPRICS (Ciclosporin to Protect Renal function In Cardiac Surgery) clinical
research team at the Department of Cardiothoracic Surgery at Skåne University
Hospital in Lund completed its planned enrolment of 150 evaluable patients. The
early Phase II CiPRICS study, using NeuroVive’s product CicloMulsion® to protect
against acute kidney injury, has been progressing well over the last few weeks
and the investigators have now moved the study into the next phase of patient
follow up and data collection.
Patients included in the CiPRICS study are observed in the hospital after
coronary artery bypass surgery (CABG) and then are subsequently followed up for
30 days. When all patients have completed follow-up and all assessment data have
been collected, it will be analysed according to a pre-specified statistical
analysis plan.  The investigators expect to complete data analysis and
communicate the CiPRICS study results during the fall of 2016.  Two safety
analyses have already been completed following the enrolment of 50 and 100
patients in the study. The CiPRICS safety evaluations have not found any
concerns regarding the treatment’s safety profile.

“We have been working closely with the Department of Cardiothoracic Surgery
research team at Skåne University Hospital and have been very pleased to see the
CiPRICS study team’s enthusiasm and professional handling of the study. They
have impressively managed to complete the study enrolment according to plan. Our
clinical development programme in acute kidney injury is one of NeuroVive’s key
priorities in 2016.  If the results are positive they will provide further
insights towards the development of both CicloMulsion® and NVP019 in this area
of high unmet medical need," commented Magnus Hansson, NeuroVive’s Chief Medical
Officer.

Acute kidney injury (AKI) may occur after major surgeries, such as CABG, which
is performed annually in over 400,000 people worldwide. There are currently no
approved preventive treatments for AKI. Patients suffering an AKI during CABG
surgery are at risk of 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, as this is a both ominous
and costly complication and a new treatment options for these patients is
needed.

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 designation in Europe and in the US for
treatment of moderate to severe traumatic brain injury and is currently being
evaluated in the CHIC study. 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® and placebo.  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 CEO Erik Kinnman or
CMO Magnus Hansson 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 7th June 2016, at 08.30 CET.
NeuroVive Pharmaceutical AB (publ) - the mitochondrial medicine company. The
company is listed on Nasdaq Stockholm, Small Cap, under the ticker symbol NVP.
The share is also traded on the OTC Markets Group Inc market in the
US. NeuroVive Pharmaceutical (OTC: NEVPF) trades on the OTCQX Best Market.
Investors can find Real-Time quotes and market information for the company
at  www.otcmarkets.com/stock/NEVPF/quote

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