This was the second of several regularly scheduled reviews by the data safety monitoring board (DSMB) that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
The Maestro-03 US pivotal Phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.
To date, more than 65% of the total number of required patients has been enrolled in the company’s Maestro-03 clinical trial, with full enrollment anticipated for the end of the first half of 2008.