Of the additional sites, the Stanford Cancer Center (Stanford, California) under principal investigator Jason Gotlib, has already commenced enrolling patients, additionally the company will start recruiting patients in other sites, shortly.
YM BioSciences said that the trial protocol has been extended to allow patients who have derived a clinical benefit to continue to receive treatment beyond the nine cycles of the core protocol. Subjects enrolled in the extension protocol will be evaluated every three months for up to 24 cycles of CYT387 treatment.
Furthermore, subject to regulatory approval, the trial will be expanded from 120 patients to 140 patients to include a 20-patient cohort to be dosed twice-daily at 150mg per dose.
YM BioSciences president and COO Nick Glover said that the initiation of this trial at additional sites reflects the growing investigator interest for CYT387 and will help ensure the timely achievement of our enrolment targets.
"Receiving clearance to extend the protocol and allow patients to remain on CYT387 therapy further demonstrates the tolerability and durability of response our drug has produced so far, Glover said.
"We anticipate this trial will be fully enrolled in the first calendar quarter of 2011 and that interim data from the fully-enrolled Phase II portion of the study will be available in mid-2011.