MediGene Publishes Update on RhuDex Incident
Autopsy findings presented
MARTINSRIED/MUNICH, Germany, July 15, 2008--Upon presentation of the autopsy findings, MediGene AG (Frankfurt, Prime Standard: MDG) is publishing an update on the recent death of a volunteer who had participated in a clinical trial of MediGene's drug candidate RhuDex®. The official death certificate includes information about the direct cause of death as well as antecedent causes and other significant conditions contributing to the volunteer's death, as identified by the Department of Pathology (Forensic Medicine) at the University of Edinburgh.
The examinations showed that the volunteer died of an acute myocardial re-infarction as a consequence of coronary thrombosis. According to the investigation, the patient had suffered several small infarctions over the past years. In addition, the autopsy revealed coronary arteriosclerosis and myocardial hypertrophy existing for years.
These findings clearly prove impairment of cardiac function in this patient that had developed for many years. From MediGene's point of view, this is backing the assessment that a causal correlation between the death of the patient, which MediGene deeply regrets, and the administration of the trial medication is unlikely.
The trial protocol of the phase I trial in question provides for a meticulous checkup of the volunteers' state of health, including a comprehensive analysis of the cardiac and vital function both prior to and following administration of the trial medication. Small infarctions may occur without chest pain and may remain unrecognised by the affected persons and undiagnosed in subsequent clinical examinations.
Until the incident has been finally clarified, MediGene continues to actively support the investigations in close co-operation with the authorities which after closing their examinations will decide about the further continuation of the clinical trial program.
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. MediGeneÒ is a trademark of MediGene AG, RhuDex® is a trademark of MediGene Ltd. These trademarks may be owned or licensed in select locations only.
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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.