CYT387: Phase I/II data

In the dose-escalation Phase I portion of a Phase I/II trial in 21 patients, 100, 150, 200, 300 and 400 mg daily CYT387 for up to 9 months significantly reduced spleen size from baseline as measured by palpation. Reversible, dose-limiting toxicities of asymptomatic grade 3 amylase and lipase elevation and grade 3 headache were observed in 2 patients at the 400 mg CYT387 dose. Based on the results, YM said it will expand enrollment in the Phase II portion of the trial to 120 from 60 patients. The Phase II portion has currently enrolled 15 patients. ...