- Significant and durable responses in anemia, splenomegaly and constitutional symptoms reported - - Well tolerated for dosing periods up to and exceeding two years - - MRI results confirm meaningful improvements in splenomegaly -
Dec. 12, 2011
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM)
, today reported updated results from the ongoing Phase I/II study of its JAK1/JAK2 inhibitor, CYT387, for the treatment of myelofibrosis. The results are being presented this evening in a poster session at the 53rd Annual Meeting of the American Society of Hematology underway in
San Diego, CA.
"In this multicenter study, CYT387 continues to demonstrate a unique ability to render and maintain myelofibrosis patients transfusion independent for clinically-relevant periods, while also producing significant and durable improvements in their splenomegaly and constitutional symptoms," said Dr.
, President and CEO of YM BioSciences. "In addition, MRI results obtained from a subset of subjects confirm the meaningful improvements in splenomegaly as measured by palpation. Moreover, CYT387 was well tolerated, with dosing up to and exceeding two years."
"While additional assessments and analyses are ongoing across dose levels, 300 mg/day appears to be a safe and effective dosing regimen that warrants further clinical development," added Dr. Glover. "We look forward to leveraging these data to advance our regulatory strategy and our business development activities with the goal of starting pivotal trials in mid-2012."
Phase I/II Study Updated Results
The Core Phase I/II study has completed enrollment of 166 myelofibrosis patients across six study sites. The Core study consists of nine 28-day treatment cycles where CYT387 is orally self-administered, primarily at dosages of 150 mg once-daily (QD), 300 mg QD or 150 mg twice-daily (BID). Patients who tolerate and benefit from the drug may continue to receive CYT387 beyond the Core study in an Extension phase. While data collection and analysis are ongoing, preliminary safety and efficacy results from this multicenter study are presented below.
The majority of the 166 patients enrolled have Primary Myelofibrosis (65%); 22% have Post-Polycythemia vera and 14% have Post-Essential thrombocythemia. Other patient characteristics include:
- DIPSS-Plus category: Int-1 - 11%; Int-2 - 61%; High - 28%
- JAK2V617F positive: 76%
- Red blood cell transfusion-dependent: 44%
- Palpable splenomegaly >10 cm: 80%
The trial also enrolled patients who had received previous therapies, including other JAK inhibitors (12%) and IMiDs (9%).