First Heart Attack Patient Treated in European Cardioprotection Phase III trial with NeuroVive's CicloMulsion[TM]
(Thomson Reuters ONE) -
Investigator-initiated European multicenter trial of 1,000 acute heart attack
patients will examine the ability of cyclosporine to protect cardiac tissue
Lund Sweden - April 19, 2011 - NeuroVive Pharmaceutical and Hospices Civils de
Lyon (HCL) today announced the enrollment and treatment of the first patient in
the European multicenter trial of myocardial infarction (the CIRCUS study).
NeuroVive's advanced CicloMulsion(TM) cremophor-free IV cyclosporine formulation
is used in this study of 1,000 patients undergoing percutaneous coronary
intervention (PCI) for acute myocardial infarction to examine cyclosporine's
ability to protect cardiac tissue. The double-blind, placebo-controlled,
investigator-initiated study is being led by trial sponsor Professor Michel
Ovize, MD, PhD, of HCL. NeuroVive is supporting the study by providing active
drug, placebo and drug logistics. The study will enroll patients at 40 centers
in France and additional European sites.
Professor Michel Ovize comments:
"Patients with myocardial infarction often undergo emergency percutaneous
coronary intervention in which a catheter passed through the major blood vessels
restores blood flow to blocked coronary arteries. Even after blood flow is
restored, damage to the heart muscle continues to progress through what is known
as reperfusion injury. Small-size proof-of-concept studies have shown that
reperfusion injury may account for as much as 30-40% of total infarction-related
myocardial damage and that timely therapeutic interventions can prevent this
damage (Staat et al. Circulation 2005; Thibault et al. Circulation 2008). From a
clinical point of view, it is critical to develop a drug to protect cardiac
tissue during PCI and hopefully improve clinical outcome."
NeuroVive CSO Associate Professor Eskil Elmer comments:
"Professor Ovize showed previously in a study published in the New England
Journal of Medicine (NEJM, 2008 Jul 31; 359 (5): 473-81) that cyclosporine
reduces reperfusion injury by approximately 40% in patients with myocardial
infarction. If, as we expect, findings are reproduced in this larger cohort of
patients with significant improvement in patient outcomes, the impressive
capability of cyclosporine as a cardiac tissue protective agent will be
confirmed."
NeuroVive's CEO Mikael Bronnegard comments:
"If efficacy is proven, NeuroVive's CicloMulsion(TM), a safe formulation of
cyclosporine, should become an important new treatment for heart patients and
reduce morbidity and mortality after myocardial infarction. In addition, it will
deliver a major reduction in the social and economic burden of heart disease and
target a significant and growing global market of patients with cardiovascular
disease."
About the CIRCUS study
The CIRCUS clinical trial (does Cyclosporine ImpRove Clinical oUtcomes in ST
elevation myocardial infarction patients?) is an "investigator-initiated trial,"
defined as undertaken as an independent scientific research initiative by the
clinical trial investigator and not at the behest of the pharmaceutical
developer or industry. NeuroVive is supporting the study by providing drug and
placebo. In total, about 1,000 patients will be entered in the trial. The impact
of cyclosporine will be evaluated against a number of objective clinical
parameters, including left ventricular function, blood markers of myocardial
infarction, quantitative assessment of myocardial infarction size, and clinical
status of the patient after completion of PCI. The enrollment period is planned
for 18 months with a 12-month follow-up period for each patient.
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.
About NeuroVive
NeuroVive Pharmaceutical AB is a Swedish drug development company whose primary
mission is to conduct research and develop pharmaceuticals that protect nerve,
cardiac and other cells undergoing health-threatening traumas or ischemia. In
addition to conducting or supporting clinical trials of NeuroSTAT® - the first
cyclophilin-D-inhibiting mitochondrial neuroprotectant - and CicloMulsion(TM),
NeuroVive is researching and developing variants of cyclophilin-D-inhibiting
cyclosporins and new ways of transporting these drugs across the blood-brain
barrier to the central nervous system. NeuroVive's shares are listed on the
Swedish trading platform AktieTorget (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.
For further information contact:
Mikael Bronnegard, MD, CEO, NeuroVive Pharmaceutical AB
Telephone: +46 46 288 0110
Cell: +46 70 299 6264
E-mail:mikael.bronnegard(at)neurovive.com
Web:www.neurovive.com
Biomedical Center BMC D10, SE-221 84 Lund, Sweden
Press Release (PDF):
http://hugin.info/139945/R/1507543/442489.pdf
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originality of the information contained therein.
Source: NeuroVive Pharmaceutical AB via Thomson Reuters ONE
[HUG#1507543]
Unternehmensinformation / Kurzprofil:
Datum: 19.04.2011 - 08:42 Uhr
Sprache: Deutsch
News-ID 53691
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contact information:
Town:
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Kategorie:
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"First Heart Attack Patient Treated in European Cardioprotection Phase III trial with NeuroVive's CicloMulsion[TM]"
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