CYT387 was well tolerated. The overall discontinuation rate was 5% and there were no patient withdrawals for drug-related adverse events. No Grade 4 non-hematological toxicities were observed. Grade 3 non-hematologic adverse events were infrequent and included increased transaminases (n=2), headache/head pressure (n=2), and increased lipase (n=3), No QTc prolongations greater than Grade 1 were observed.
Some patients experienced a "first-dose effect" characterized by Grade 1 lightheadedness (26 subjects, 43%) and hypotension (31 subjects, 52%). The phenomenon was self-limiting, generally resolved within 3-4 hours and did not recur after the first dose.
Grade 3/4 thrombocytopenia was seen in 16 (27%) subjects. It should be noted that the minimum platelet count specified in the inclusion criteria for the study is 50,000/mcl. The majority of Grade 3/4 thrombocytopenia were observed in subjects where baseline platelet counts were less than 100,000/mcl.
Treatment-emergent Grade 3 anemia was seen in four subjects (7%). None of the subjects developed new red cell transfusion requirements. Treatment-emergent Grade 3/4 neutropenia was seen in three subjects (5%).
For more information on the CYT387 Phase I/II trial, go to:
Notice of Meeting/Conference Call:
YM Management will be hosting an analyst and investor meeting at the Hilton Orlando, Lake Sheen A Room, to discuss these results. The meeting will be hosted by Dr. Nick Glover, President and Chief Executive Officer of YM BioSciences and will include a re-presentation of the results by the Principal Investigator for the trial, Dr. Animesh Pardanani, Mayo Clinic, joined by the Study's Chair, Dr. Ayalew Tefferi, Mayo Clinic. Also participating will be Dr. Mark Kowalski, Chief Medic
|SOURCE YM BioSciences Inc.|
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