Dr. Axel Mescheder, MediGene's Executive Board Member for Research & Development commented: "Our discussions with the regulatory authorities have proceeded in a very constructive manner, and we appreciate the Agency's suggested examinations in the interests of patient safety. The results of these studies will be a prerequisite for the further clinical development of RhuDex(TM)."
In July 2008, MediGene put a Phase I study of a new formulation of RhuDex(TM) on hold after a volunteer died of myocardial infarction during the course of the trial. The autopsy revealed that the volunteer had been suffering from severe impairment of cardiac function before admission to the trial. Other than in this patient, no clinically relevant cardiac symptoms have been observed in any clinical trial of RhuDex(TM), which in total have now included approximately 80 patients.
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.
MediGene AG is a publicly listed (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. MediGene has several drug candidates in clinical development, including EndoTAG(TM)-1 which could offer substantial sales returns. In addition, the company has numerous projects in research and pre-clinical development and possesses innovative platform technologies. MediGene focuses on the research and development of novel drugs for the treatment of cancer and autoimmune diseases.
