This was the third of several regularly scheduled reviews by the data safety monitoring board (DSMB) that will occur over the duration of the trial, in order to provide objective, independent safety monitoring of the trial.
“The DSMB reviewed safety data from our trial, including data from MRI scans conducted on the first 100 patients dosed in study, who are undergoing an extensive safety analysis as per the trial design,” said Kevin Giese, president of BioMS Medical. “This third positive recommendation by the DSMB members highlights the steady progress being made in advancing our pivotal trial.”
The pivotal phase II/III study is now ongoing at trial sites across Canada, the UK and Sweden.