MediGene AG Puts Clinical Phase I Study with RhuDex(R) on Hold

What can happen with clinical trials, the death of one participant, which has not been fully determined as to whether or not the drug was the cause, puts a halt to the study. Something to keep in mind when considering volunteering for a study, there are no guarantees here. This also makes a very strong case for the rapid development of gene sequencing and personalized medicine, as if some additional preliminary information is available relative to a drug becoming toxic at certain levels or within a directed treatment plan, it is certainly better than even the best calculated “hit and miss” trials being conducted, but until recently, this is all we have had. BD

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.