July 23, 2008
MethylGene and Celgene Suspend Enrollments into Tumor Drug Study
MethylGene and Celgene have announced that, at the recommendation of a standing internal safety committee, the companies are temporarily suspending enrollment of new patients into clinical trials evaluating MGCD0103.
This voluntary precaution is being taken due to the observation of pericarditis or pericardial effusion in 19 patients out of approximately 400 patients treated to date. Approximately half of the reported cases have been deemed by investigators as unlikely to be drug related. It is not yet determined whether the potential signal is drug related due to confounding factors in these complex and late-stage cancer patients.MGCD0103 is an orally-administered, isoform-selective HDAC inhibitor. Because the events tend to occur during the first cycle of treatment, patients currently enrolled in MGCD0103 clinical trials who have no signs or symptoms of the events are not affected by this temporary action and may continue in their respective studies.
The companies are working to fully communicate this precautionary measure to the appropriate investigators and regulatory agencies. Additionally, the companies are putting in place a series of steps moving forward to provide safe access to the clinical benefits of this promising therapy as soon as possible.