|YM Biosciences Offers Interim Results from Jak Inhibitor CYT387 Study; Sanofi, Regeneron Begin Enrollment in PCSK9|
|By Staff and Wire Reports|
|Monday, 05 November 2012 20:07|
YM BioSciences Inc. (NYSE: YMI) reported interim results from the Phase I/II study of CYT387, a JAK1/JAK2 inhibitor currently being evaluated for the treatment of myelofibrosis, which were included in an abstract submitted to the American Society of Hematology in August 2012. Updated results will be presented in an Oral Session at the 2012 Annual Meeting of the American Society of Hematology to be held in Atlanta, Georgia on December 9, 2012.
The CYT387 Phase I/II study enrolled 166 patients across six study sites. At the time the ASH abstract was submitted, the median duration of follow-up was 16.1 months (ongoing) with a range of 0.7 to 31.0 months (ongoing).
* Durable transfusion independence responses were observed in more than half of the RBC transfusion dependent subjects with a maximal transfusion-free period exceeding two years and ongoing. In addition, the percentage of all subjects requiring RBC transfusions substantially decreased over the treatment period. * Treatment with CYT387 resulted in rapid and sustained reductions in splenomegaly with a maximal response duration approaching two years. * The majority of subjects reporting constitutional symptoms at baseline experienced complete resolution or marked improvement by six months with measurable improvement within the first month of therapy. * Higher transfusion independence and spleen response rates were seen in the 300mg dose group compared to the 150mg QD or 150mg BID dose groups. * While 90% of subjects reported at least one treatment-related AE, the majority were reported as Grade 1.
For the first 60 consecutively enrolled subjects for whom the most mature data is available, the median follow-up period was 21.5 months (ongoing) with a range of 2.9 to 31.0 months (ongoing).
* The anemia and spleen response rates in these subjects, per IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment), were 59% and 48%, respectively. * Among 33 of these subjects who were RBC transfusion dependent by IWG-MRT criteria, 70% achieved a minimum 12-week period without transfusions, with a maximal transfusion-free period of greater than two years and ongoing.
Sanofi (NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the ODYSSEY OUTCOMES trial, a Phase 3 cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients. SAR236553/REGN727 is an investigational subcutaneously administered, fully-human antibody that is being evaluated for its impact on lowering low-density lipoprotein cholesterol (LDL-C) by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).
The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents. With the start of this study, eleven trials are now recruiting in the global SAR236553/REGN727 Phase 3 program.
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YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company advancing hematology and cancer related products, today reported interim results from the Phase I/II study of CYT387, a JAK1/JAK2 inhibitor currently being evaluated for the treatment of myelofibrosis, which were included in an abstract submitted to the American Society of Hematology in August 2012.