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Last updated on April 17, 2014 at 8:20 EDT

600th Heart Attack Patient Recruited into Phase III CicloMulsion® CIRCUS Trial

March 22, 2013

LUND, Sweden, March 22, 2013 /PRNewswire/ –

NeuroVive, a leading mitochondrial medicine company, announces that the 600th patient
has been recruited to a pivotal Phase III European, multi-center trial (CIRCUS trial)
assessing CicloMulsion(R) (a special formulation of cyclosporine for acute cardiac
injuries) for the treatment of heart reperfusion injury following stenting in patients
with myocardial infarction.

The CIRCUS trial (does Cyclosporine ImpRove Clinical oUtcome in ST elevation
myocardial infarction patients) is assessing CicloMulsion(R) in a study of nearly 1,000
patients undergoing stenting following acute myocardial infarction to examine its ability
to protect cardiac tissue and improve clinical outcome. CicloMulsion(R) is a
Cremophor(R)-free formulation of the cyclophilin inhibitor, cyclosporine, under clinical
development by NeuroVive for the treatment of cardiac reperfusion injury.

In 2008 a 58 patient study published in the New England Journal of Medicine (NEJM,
2008 Jul 31; 359 (5): 473-81) showed cyclosporine, when administered immediately prior to
stenting, could reduce reperfusion injury by 40% in patients with myocardial infarction.
The CIRCUS trial is designed to confirm these results in a much larger patient group.

The trial is a multicentre, randomized, placebo-controlled, double-blind,
investigator-initiated study. Patients receive one single injection of CicloMulsion(R) (or
placebo) prior to reperfusion therapy by stenting. The incidence of the combined endpoint
(mortality, hospitalization for heart failure, left ventricular (LV) remodelling) is then
assessed one year after treatment to determine whether cyclosporine can improve ST
Elevation acute Myocardial Infarction (STEMI) patient clinical outcome. The study also
includes a number of secondary outcome measures designed to provide a more detailed
insight into CicloMulsion’s ability to reduce a patient’s level of cardiac injury
following stenting.

The trial is being led by trial sponsor Professor Michel Ovize, MD, PhD, of the
University Hospital in Lyon (HCL), a leading expert in the field of cardiovascular
medicine and it is conducted by a CRO unit within the hospital according to good clinical
practice (GCP) guidelines. The study is enrolling patients at centres in France and
additional sites in Belgium and Spain and is being funded by a number of European grant
and public funding bodies. NeuroVive is supporting the study by providing active drug,
placebo and drug logistics.

NeuroVive and HCL have recently agreed terms for the commercial use of the CIRCUS
trial data which it expects to report in early 2015. If successful, NeuroVive intends to
use these data as part of a planned marketing authorization application with the EMA.

Mikael Bronnegard, CEO of NeuroVive Pharmaceutical said: “The CIRCUS trial is very
important for NeuroVive since if it confirms earlier trial results and demonstrates a
significant improvement in patient outcome it will reinforce our view that CicloMulsion(R)
is an important new treatment for heart reperfusion injury following stenting. Therefore,
the fact that the 600th patient has been recruited to the trial is greatly encouraging.
The trial has been designed and conducted to the highest standards and we intend to use
the data from this pivotal study for a Marketing Authorization Application in Europe for
CicloMulsion(R).”

Professor Michel Ovize commented: “Reperfusion injury following stenting is affecting
a growing global patient population suffering from cardiovascular disease. This group
represents a huge medical need and one for which there are currently no approved
pharmaceutical treatment options available. It is therefore critical to develop a drug to
protect cardiac tissue following stenting. Cyclosporine has already shown the potential to
reduce significantly the level of reperfusion injury and we are looking forward to
confirming this important finding in the current CIRCUS study.”

The novel Cremophor(R)-free formulation for cyclosporine

CicloMulsion(R) is a special formulation of cyclosporine for use in acute cardiac
indications. It has the following advantages:

(i) Ready-to-use solution. The ready to hang and administer bottles do not require
dilution from a concentrate, thus reducing measuring and dosing errors.

(ii) Formulated with physiological fats and phospholipids that can be readily
metabolized by the human body.

(iii) No risk of Cremophor(R)-related severe hypersensitivity reactions or
anaphylactic reactions.

(iv) No risk of Cremophor(R)-related cyto-, nephro- and cardiotoxicity.

About NeuroVive Pharmaceutical AB (publ)

NeuroVive Pharmaceutical AB (http://www.neurovive.com), a leading mitochondrial
medicine company is developing a portfolio of products to treat acute cardiovascular and
neurological conditions through mitochondrial protection.

NeuroVive’s products are based on the cyclophilin inhibitor cyclosporine and work by
preventing the death of mitochondria in distressed cells and the subsequent cascade of
intracellular biochemical events that lead to secondary tissue damage following an acute
cardiac or traumatic brain injury.

NeuroVive’s lead product is CicloMulsion(R), the first cyclophilin inhibitor for the
treatment of reperfusion injuries following stenting. CicloMulsion(R) is currently in a
1000 patient Phase III clinical trial evaluating its ability to reduce reperfusion
injuries in patients with myocardial infarction.

NeuroVive is also developing NeuroSTAT(R), a cyclophilin inhibitor, which is soon
expected to enter a Phase IIa clinical trial in patients with severe traumatic brain
injury. Both indications have huge medical need and for which there are currently no
approved pharmaceutical treatment options. Both CicloMulsion(R) and NeuroSTAT(R) are
special formulations of cyclosporine for use in acute cardiac and brain injury
indications.

NeuroVive’s pipeline includes novel cyclophilin inhibitors, and drug candidates that
act on mitochondria to address energy regulation disorders.

NeuroVive’s shares are listed on the Swedish trading platform AktieTorget
(http://www.aktietorget.se). The AktieTorget market is focused on emerging,
entrepreneurial businesses through an electronic trading system supplied by the OMX Nordic
stock exchange in Stockholm, Sweden.

About the Hospices Civils de Lyon

University Hospital of Lyon (HCL) is a public institution and the second-largest
university hospital in France, with an annual budget of over 1.3 billion euros. It covers
five hospital clusters in the Lyon urban area and a large number of academic research
laboratories. HCL employs 20,000 people, including 2,700 physicians with the latest and
most advanced technology to improve patient care not only in Lyon but also globally. HCL
handles about 530 emergency cases and more than 2,300 outpatient visits daily.

HCL’s capabilities include clinical trials (three clinical trial centers) and contract
manufacturing for the production of pharmaceuticals and contract research. HCL has one of
Europe’s best-developed university structures in terms of clinical research and clinical
drug trials. Responsibility for clinical research and clinical trial programs rests with
the Division of Clinical Research and Innovation (DRCI). HCL has 5,000 hospital beds
providing an environment conducive to conducting clinical research. Each year there are
approximately 500 clinical research projects within the framework of HCL’s business and up
to 2009 more than 1000 clinical trials in various specialties had been performed.

        Media and investor relations contacts
        NeuroVive Pharmaceutical: Mikael Bronnegard
        Email: info@neurovive.com
        Phone No: +46-(0)70-299-62-64

        Citigate Dewe Rogerson: Nina Enegren / David Dible
        Email: nina.enegren@citigatedr.co.uk
        Phone No: +44-(0)207-282-1050

SOURCE NeuroVive Pharmaceutical AB


Source: PR Newswire