Neurovive Pharmaceutical: Topline Result of Phase III Study of Ciclomulsion® in Acute Myocardial Infarction Expected This Qu...
25 May 2015 - 4:43PM
Business Wire
Regulatory News:
NeuroVive Pharmaceutical AB (STO:NVP) , the mitochondrial
medicine company, expects to announce the topline result of the
phase III CIRCUS study of CicloMulsion® in patients with a specific
type of heart attack known as ST-segment elevation acute myocardial
infarction (STEMI) this quarter due to an earlier than previously
expected database lock. The final results of the analysis of the
12-month data are expected in the third quarter 2015.
The topline result will provide baseline information on whether
the primary endpoint has been met or not. This result will not
contain specific data concerning the level of
significance for neither the combined composite endpoint
itself nor for each individual element of the
composite, which will be revealed in the
subsequent detailed analysis. The primary endpoint is a
composite of three separate outcomes: mortality, hospitalizations
for heart failure and left-ventricular remodeling.
The impact of these results on the future development of
CicloMulsion® will be communicated in the second half of 2015.
About CicloMulsion®
NeuroVive’s drug candidate CicloMulsion®, a lipid emulsion
formulation of cyclosporine, is the first cyclophilin inhibitor in
development for the treatment of reperfusion injury. It is designed
to prevent mitochondrial death in damaged cells and limit the
numerous biochemical processes that lead to secondary tissue damage
following heart attack. By protecting the cells’ mitochondria,
CicloMulsion® may safeguard continued energy production and ensure
that the damaged cells’ normal regenerative mechanisms are able to
carry out repairs and maintain cell functionality. CicloMulsion®’s
potential for treatment in connection with myocardial infarction is
currently being evaluated in a clinical phase III study.
CicloMulsion® is also being evaluated in a phase II study for the
prevention of renal injury during major heart surgery with Skåne
University Hospital in Lund, Sweden. CicloMulsion® is an
investigational product and has not been approved by regulatory
agencies for the treatment of any medical condition.
About the ongoing phase III study on CicloMulsion®
The ongoing European phase III study on CicloMulsion® (the
CIRCUS study) is being conducted in France, Belgium and Spain. The
study evaluates CicloMulsion® for the treatment of reperfusion
injury in patients that have undergone percutaneous coronary
intervention (PCI) following myocardial infarct. The researcher
responsible for the study is Professor Michel Ovize at Hospices
Civils de Lyon (HCL) in Lyon, France. The study is a double-blind,
placebo-controlled study, and the final of a total 975 patients
included in the study was enrolled in February 2014. The top-line
result (met or did not meet primary endpoint) based on the 12-month
follow-up of all patients is expected to be announced in the second
quarter of 2015, and the full results of the 12-month data are
expected in the third quarter of 2015. The study will also evaluate
outcomes at 36 months.
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. NeuroVive’s drug candidate CicloMulsion® is being
evaluated in an ongoing phase III study, CIRCUS, in myocardial
infarction and a phase II study, CiPRICS, in acute kidney injury.
The drug candidate NeuroSTAT® is currently being evaluated in a
phase II study in traumatic brain injury. NeuroVive’s research
programs also include development of drug substances against brain
injury in stroke patients and for cellular protection and energy
regulation in mitochondrial disease. NeuroVive’s shares are listed
on NASDAQ OMX, Stockholm, Sweden.
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 25 May
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/NEVPF/quot)
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Laika ConsultingIngmar RentzhogTel: +46 (0)46 275 62
21ir@neurovive.seIt is also possible to arrange an interview with
NeuroVive’s CEO Mikael Br�nnegård or COO Jan Nilsson at the above
contact.