MediGene Receives Authorization for the Clinical Formulation Study of RhuDex®
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MediGene AG /
MediGene Receives Authorization for the Clinical Formulation Study of RhuDex®
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Martinsried/Munich, October 28, 2011.MediGene AG (Frankfurt: MDG, Prime
Standard) announced today that the United Kingdom Medicines and Healthcare
Products Regulatory Agency (MHRA) granted the authorization of the planned
clinical formulation study of RhuDex(®), a drug candidate being developed for
the treatment of rheumatoid arthritis. The objective of the RapidFACT(TM) trial
(Rapid Formulation Development and Clinical Testing) is to determine an
optimized formulation for chronic treatment. Upon the initiation of the planned
study, MediGene will provide additional details on the design and duration of
the trial.
Dr. Frank Mathias, MediGene's CEO, commented: "Preliminary formulations of
RhuDex(®) permitted initial clinical trials of the drug candidate. For the long-
term development and subsequent marketability of the product, however, we seek
an improved formulation and dosage form of RhuDex(®) to facilitate a
therapeutically ideal release of the active ingredient as well as patient-
friendly dosing. We are delighted to be able to continue the clinical
development of RhuDex(®) with an optimized product candidate."
RhuDex(®): RhuDex(® )is an oral therapy being developed as a disease-modifying
drug for the treatment of rheumatoid arthritis targeting the successful group of
Disease-Modifying Antirheumatic Drugs (DMARDs). RhuDex(®) is an orally
administered CD80 antagonist that blocks undesired activation of T-cells and has
an immunomodulating and anti-inflammatory effects. In a Phase IIa trial in 29
patients, RhuDex(®) demonstrated first indications of biological activity.
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 forward-looking statements made
herein. MediGene is not bound to update any of these forward-looking statements.
MediGene(®) and RhuDex(®) are registered trademarks of MediGene AG. These
trademarks may be owned or licensed in select locations only.
- ends -
MediGene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology
company headquartered in Martinsried/Munich, Germany. MediGene is the first
German biotech company to have revenues from marketed products. It has various
drug candidates in clinical development and possesses innovative platform
technologies. MediGene focuses on clinical research and development of novel
drugs against cancer and autoimmune diseases.
Contact MediGene AG
Julia Hofmann, Kerstin Langlotz
Investor & Public Relations
Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20
Email: investor(at)medigene.com
--- End of Message ---
MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN: 502090;ISIN: DE0005020903;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg,
Freiverkehr in Börse Düsseldorf,
Freiverkehr in Bayerische Börse München,
Freiverkehr in Niedersächsische Börse zu Hannover,
Prime Standard in Frankfurter Wertpapierbörse,
Regulierter Markt in Frankfurter Wertpapierbörse;
press release as pdf:
http://hugin.info/132073/R/1558873/481818.pdf
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originality of the information contained therein.
Source: MediGene AG via Thomson Reuters ONE
[HUG#1558873]
Unternehmensinformation / Kurzprofil:
Datum: 28.10.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 81331
Anzahl Zeichen: 4516
contact information:
Town:
Martinsried / München
Kategorie:
Business News
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