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MediGene Publishes Update on RhuDex® Incident |
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Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
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Autopsy findings presented
Martinsried/Munich, July 15, 2008. Upon presentation of the autopsy
findings, MediGene AG (Frankfurt, Prime Standard: MDG) is publishing
an update on the recent death of a volunteer who had participated in
a clinical trial of MediGene's drug candidate RhuDex®. The official
death certificate includes information about the direct cause of
death as well as antecedent causes and other significant conditions
contributing to the volunteer's death, as identified by the
Department of Pathology (Forensic Medicine) at the University of
Edinburgh.
The examinations showed that the volunteer died of an acute
myocardial re-infarction as a consequence of coronary thrombosis.
According to the investigation, the patient had suffered several
small infarctions over the past years. In addition, the autopsy
revealed coronary arteriosclerosis and myocardial hypertrophy
existing for years.
These findings clearly prove impairment of cardiac function in this
patient that had developed for many years. From MediGene's point of
view, this is backing the assessment that a causal correlation
between the death of the patient, which MediGene deeply regrets, and
the administration of the trial medication is unlikely.
The trial protocol of the phase I trial in question provides for a
meticulous checkup of the volunteers' state of health, including a
comprehensive analysis of the cardiac and vital function both prior
to and following administration of the trial medication. Small
infarctions may occur without chest pain and may remain unrecognised
by the affected persons and undiagnosed in subsequent clinical
examinations.
Until the incident has been finally clarified, MediGene continues to
actively support the investigations in close co-operation with the
authorities which after closing their examinations will decide about
the further continuation of the clinical trial program.
This press release contains forward-looking statements representing
the opinion of MediGene as of the date of this release. The actual
results achieved by MediGene may differ significantly from the
statements made herein. MediGene is not bound to update any of these
forward-looking statements. MediGeneÒ is a trademark of MediGene AG,
RhuDex® is a trademark of MediGene Ltd. These trademarks may be owned
or licensed in select locations only.
- ends -
MediGene AG is a publicly quoted (Frankfurt, Prime Standard: MDG)
biotechnology company located in Martinsried/Munich, Germany, with
subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first
German biotech company to have drugs on the market, which are being
distributed by partner companies. Another drug candidate has just
received official recommendation for marketing authorization by the
EMEA. MediGene has several drug candidates in clinical development.
Moreover, the company has projects in research and pre-clinical
development and possesses innovative platform technologies. MediGene
concentrates on researching and developing novel drugs for the
treatment of cancer and autoimmune diseases.
Contact MediGene AG
E-mail: investor@medigene.com
Fax:++49 - 89 - 85 65 - 2920
Julia Hofmann / Dr. Georg Dönges, Public Relations, Tel.: ++49 - 89 -
85 65 - 3317
Dr. Michael Nettersheim / Dr. Georg Dönges, Investor Relations, Tel.:
++49 - 89 - 85 65 - 2946
--- End of Message ---
MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN:
502090; ISIN: DE0005020903 ;
Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in
Bayerische Börse München,
Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr
in Niedersächsische Börse zu Hannover,
Geregelter Markt in Frankfurter Wertpapierbörse; Copyright © Hugin AS 2008. All rights reserved.
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