Below is the original Quest story titled ACE-031 Clinical Trials in Duchenne MD Stopped for Now, which was published May 3, 2011.
Biopharmaceutical companies Acceleron Pharma and Shire announced April 21, 2011, that MDA-supported clinical trials of ACE-031 for Duchenne muscular dystrophy (DMD) have been halted.
A phase 2, dose-escalation study of ACE-031 in boys with DMD has been terminated, and the extension study for boys who have completed the original study has been suspended, based on preliminary safety data.
Both studies were being conducted in Canada, and the plan was to open study sites in the United States some time in the future.
The adverse events that the trial participants experienced ***8212; minor nose and gum bleeding and dilation of blood vessels in the skin ***8212; were not, in and of themselves, considered dangerous. However, the companies and regulatory agencies involved say they need to fully understand these events before continuing clinical studies of ACE-031.