YM BioSciences JAK Inhibitor CYT387 Produces Meaningful Reductions
of Splenomegaly and Durable Transfusion Independence Responses
MISSISSAUGA,
ON, Nov. 5, 2012 /PRNewswire/
- 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. 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.
"Treatment with CYT387 provides sustained
transfusion independence in a substantial number of patients with
myelofibrosis. In addition, many patients experience rapid,
meaningful and durable reductions of splenomegaly and improvements
of constitutional symptoms. CYT387 has also proven safe for
patients and well-tolerated, even with prolonged administration of
more than two and a half years," said Mark
Kowalski, M.D., Ph.D., Chief Medical Officer and Vice
President, Regulatory Affairs at YM BioSciences. "We look forward
to expanding on these results at ASH when we report final
nine-month data from this trial."
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.
ASH Oral Session:
Title: Phase I/II Study of CYT387, a JAK1/JAK2 Inhibitor for the
Treatment of Myelofibrosis Session Name: 634. Myeloproliferative
Syndromes - Clinical: Myeloproliferative Neoplasms - Novel
Therapies I
Session Date: Sunday, December 9,
2012; 4:30 PM - 6:00 PM
(Presentation Time: 5:15
PM)
Location: Georgia World Congress Center, Room B213-B214
About CYT387:
CYT387 is an orally administered inhibitor of
both the JAK1 and JAK2 kinases, which have been implicated in a
family of hematological conditions known as myeloproliferative
neoplasms, including myelofibrosis, and as well in numerous other
disorders including indications in hematology, oncology and
inflammatory diseases. Myelofibrosis is a chronic debilitating
disease in which a patient's bone marrow is replaced by scar tissue
and for which treatment options are limited or unsatisfactory. Both
the U.S. Food and Drug Administration (FDA) and the European
Commission have designated CYT387 an Orphan Drug for the treatment
of myelofibrosis.
About YM BioSciences
YM BioSciences Inc. is a drug development
company primarily focused on advancing CYT387, an orally
administered inhibitor of both the JAK1 and JAK2 kinases, which
have been implicated in a number of hematological and immune cell
disorders including myeloproliferative neoplasms and inflammatory
diseases as well as certain cancers. Positive interim results have
been reported from a Phase I/II trial of CYT387 in 166 patients
with myelofibrosis. YM's portfolio also includes nimotuzumab, a
humanized monoclonal antibody targeting EGFR with an enhanced
side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and
III trials worldwide. In addition, YM has several preclinical
programs underway with candidates from its library of novel
compounds identified through internal research conducted at YM
BioSciences Australia.
This press release may contain
forward-looking statements, which reflect the Company's current
expectation regarding future events. These forward-looking
statements involve risks and uncertainties that may cause actual
results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not
limited to, changing market conditions, the successful and timely
completion of clinical studies, the establishment of corporate
alliances, the impact of competitive products and pricing, new
product development, uncertainties related to the regulatory
approval process or the ability to obtain drug product in
sufficient quantity or at standards acceptable to health regulatory
authorities to complete clinical trials or to meet commercial
demand; and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting. Certain of the assumptions
made in preparing forward-looking statements include but are not
limited to the following: that CYT387 and nimotuzumab will generate
positive efficacy and safety data in ongoing and future clinical
trials, and that YM as well as CIMYM's various licensees will
complete their respective clinical trials and disclose data within
the timelines communicated in this release. Except as required by
applicable securities laws, we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
SOURCE YM BioSciences Inc.