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2016-03-14

Neurovive Pharmaceutical: 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/NEVPF/quot)

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http://news.cision.com/neurovive-pharmaceutical/r/neurovive-announces-th...
http://mb.cision.com/Main/6574/9933531/488049.pdf

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