||| Menü 
Startseite
Firmenveranstaltungen, Neuemissionen

10/11
09/11
08/11
07/09
08/09
09/09
10/09
11/09
12/09
01/10
02/10
03/10
Geschäftsberichte, Werbung, Earnings, Marketing, Verordnungen

10/11
09/11
03/09
04/09
05/09
06/09
08/09
09/09
10/09
11/09
12/09
01/10
02/10
Fusionen, Übernahmen

11/11
12/08
01/09
02/09
03/09
04/09
05/09
06/09
07/09
08/09
09/09
10/09
11/09
Personal, Belegschaft, Meldungen zu Produkten

06/08
07/08
08/08
09/08
10/08
11/08
12/08
01/09
02/09
03/09
04/09
05/09
06/09
07/09
08/09

Datenschutz
Impressum
Bankleitzahlen - online.de


RhuDex(TM) Clinical Development to Continue Following Feedback from Regulatory Authorities

Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




Martinsried/Munich, October 5, 2009. MediGene AG (Frankfurt: MDG,
Prime Standard, TecDAX) received feedback from the UK MHRA (Medicines
and Healthcare products Regulatory Agency) regarding the in-vitro
studies conducted with the drug candidate RhuDex(TM) for the
treatment of rheumatoid arthritis. These in-vitro studies examined
potential effects of RhuDex(TM) on the vascular system or any
arteriosclerotic blood vessels. Since these tests did not suggest any
negative effects of RhuDex(TM), the MHRA agreed to a continuation of
the drug candidate's clinical development, without requesting any
further in vitro or ex vivo data.

MediGene is planning to resume the Phase I clinical development for
RhuDex(TM), thus laying the necessary foundation for a clinical Phase
II trial in patients. As the extended plan for clinical development
is drafted, MediGene will coordinate with the competent regulatory
authorities.

Following a successful Phase IIa trial in 29 patients during the
first six months of 2008, MediGene conducted a clinical Phase I trial
of a new tablet formulation of RhuDex(TM). This trial was put on hold
in July 2008, following the death of a trial participant from
myocardial infarction. The autopsy, revealed severe impairment of
cardiac function of the volunteer deemed to be present prior to
admission to the trial, as well as other scientific findings.
MediGene considered any causal correlation between the death of the
patient and the administration of RhuDex(TM) to be unlikely, but for
safety reasons the Company proceeded to test RhuDex(TM) in a series
of further laboratory studies in coordination with the MHRA.

Dr. Axel Mescheder, CSO & CDO of MediGene AG: "We are very happy that
we are in a position to continue clinical development of this
innovative drug candidate for the treatment of immune-mediated
diseases. We are pleased that the decision by MHRA is in line with
MediGene's assessment. "

RhuDex(TM): RhuDex(TM) is being developed as a disease-modifying drug
for the treatment of rheumathoid arthritis, aiming at the successful
group of "Disease-Modifiying Antirheumatic Drugs" (DMARDs). As the
first orally administered and at the same time specifically effective
DMARD, RhuDex(TM) may provide a distinct competitive advantage. The
mode of action of RhuDex(TM) is targeted at stopping T-cell
activation by specifically blocking the very well-defined target
protein CD80, thus inhibiting the release of cytokines which
stimulate inflammation. Thus the disease-causing mechanism inhibited
in a very specific way.
Rheumatoid arthritis: rheumatoid arthritis is the most common
inflammatory arthropathy worldwide. More than 1% of the world
population is affected by this chronic, systemic disease of the
connective tissue which leads to pain, deformity, restricted
mobility, and often to stiffening of the joints affected.

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. MediGene® is a registered trademark of
MediGene AG. RhuDex(TM) is a registered trademark of MediGene Ltd.
These trademarks may be owned or licensed in select locations only.

- ends -


MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard,
TecDax) biotechnology company located in Martinsried/Munich, Germany,
Oxford, UK, and San Diego, USA. MediGene is the first German biotech
company to have drugs on the market, which are distributed by partner
companies. MediGene has several drug candidates in clinical
development, two of which provide significant sales potential. In
addition, the company pursues several development projects and
possesses innovative platform technologies for drug development.
MediGene focuses on clinical research and development of 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. Nadja Wolf, Public Relations, Tel.: ++49 - 89 -
85 65 - 3324
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, Regulierter
Markt in Frankfurter Wertpapierbörse,
Freiverkehr in Börse Stuttgart, Freiverkehr in Bayerische Börse
München,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr
in Niedersächsische Börse zu Hannover,
Freiverkehr in Börse Düsseldorf;
Copyright © Hugin AS 2009. All rights reserved.



 
 ||| Themen-Infos 
· Mehr zu dem Thema Contracts & Corporate events & IPOs &

Der meistgelesene Artikel zu dem Thema Contracts & Corporate events & IPOs &:
Change on the Board of Directors of Feintool Holding AG

 ||| Artikel Bewertung 
durchschnittliche Punktzahl: 0
Stimmen: 0

Bitte nehmen Sie sich einen Augenblick Zeit, diesen Artikel zu bewerten:

Exzellent
Sehr gut
gut
normal
schlecht



Web site engine's code is Copyright © 2003 by PHP-Nuke. All Rights Reserved. PHP-Nuke is Free Software released under the GNU/GPL license.
Erstellung der Seite: 0.087 Sekunden