YM BioSciences Inc. YMI 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. 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.
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