News

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

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.

 

 

 

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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