Martinsried/Munich July 8, 2008. MediGene AG (Frankfurt, Prime Standard: MDG) has put an ongoing phase I study involving the drug candidate RhuDex® on hold. According to information obtained by MediGene, one of the volunteers participating in the study suffered a heart problem some days after one of the scheduled treatments of RhuDex®. The patient was subsequently treated in hospital and discharged a few days later. Several days after being discharged the volunteer unfortunately died at home. Investigations into the cause of death will be carried out but it is currently unclear whether or not there is any correlation between this sad event and the drug administration.
MediGene reported the event immediately to the relevant authorities and is investigating the possible causes of this event in coordination with the authorities. So far, about 80 individuals have been treated with this drug candidate and no comparable events occurred in the other subjects in this study or in previous clinical studies. Furthermore in extensive and relevant preclinical programs no signs of cardiac effects due to RhuDex® was observed. The eleven other volunteers included in the current phase I study showed only mild side effects like headaches. For the time being, the current study has been put on hold.
The phase I study concerned is investigating the bioavailability (drug concentration in the blood after administration) of RhuDex® in a new formulation. Recently, MediGene announced positive safety data for RhuDex® in a phase IIa trial in patients with rheumatoid arthritis.
RhuDex®: RhuDex® is being developed as a disease-modifying anti-rheumatic drug (DMARD). RhuDex® is the first orally administered DMARD specifically designed to inhibit T-cell activation. By specifically blocking the very well defined target protein CD80, the release of cytokines which stimulate inflammation is significantly decreased.
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 trademark of MediGene AG, RhuDex® is a trademark of MediGene Ltd. These trademarks may be owned or licensed in select locations only.
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
