MISSISSAUGA, ON, Aug. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Amex: YMI, TSX:YM), announced the conclusion of dose-escalation in the Phase I portion of its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis. In total, 21 patients were treated in Phase I, with no voluntary withdrawals reported. CYT387 has shown significant activity in reducing spleen size and controlling constitutional symptoms in these patients. To date, 15 patients have been enrolled into the Phase II portion of the study. Given the favourable biological activity and safety data, the Company intends to expand the present program from 60 to 120 patients at up to six centers in the United States, Canada and Australia, subject to regulatory approval. Detailed safety and activity data for CYT387 are planned to be presented at the American Society of Hematology (ASH) meeting in Orlando, Florida in December this year.
Myelofibrosis is a chronic debilitating unmet medical need, in which a patient's bone marrow is replaced by scar tissue and for which treatment options are limited or unsatisfactory due to both efficacy and safety concerns.
Dosing in the Phase I dose-escalation portion of the study commenced in November 2009. In total, 21 patients were treated across five dosing levels (100, 150, 200, 300 and 400mg daily for up to nine months). Reversible, dose-limiting toxicities (DLTs) were observed in two patients at the 400mg dose-level, namely an asymptomatic Grade 3 amylase and lipase elevation and a Grade 3 headache with both patients subsequently resuming treatment with CYT387 at reduced doses.
|SOURCE YM BioSciences Inc.|
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