MISSISSAUGA, ON, April 18 /PRNewswire/ - YM BioSciences Inc.
(NYSE Amex: YMI, TSX: YM), today announced that updated interim
anemia response data were reported for the first 60 patients
enrolled in the Phase I/II trial of its JAK1/JAK2 inhibitor,
CYT387, for the treatment of myelofibrosis. The results were
disclosed by Dr. Ayalew Tefferi
(Mayo Clinic, Rochester,
Minnesota), Chair of the Study, during the First Annual
Florence Meeting on Myeloproliferative Neoplasms held in
Florence, Italy on Saturday, April 16th, 2011.
"These results continue to highlight the
potential for CYT387 to induce durable anemia responses, as
demonstrated using these more rigorous measurement standards," said
Dr. Nick Glover, President and CEO
of YM BioSciences. "We look forward to reporting updated interim
data on CYT387's safety and efficacy profile at the ASCO conference
in June."
Dr. Tefferi reported that the overall anemia
response rate was 58% in 33 transfusion-dependent patients. In this
assessment, anemia response required a transfusion-free period of
≥12 weeks while on protocol drug therapy, with a minimum hemoglobin
level of 8 g/dL. The median duration of transfusion
independence was reported to be 6 months (range 4-15 months).
Only 2 (11%) of the 19 patients who achieved
transfusion-independency were reported to require single episodes
of PRBC transfusions.
The results were based on data observed for the
first 60 patients enrolled in the dose escalation (n=21) and dose
confirmation (n=39) portions of the 140 patient Phase I/II trial,
for which recruitment has now been exceeded. These 60
high/intermediate-risk myelofibrosis patients have received CTY387
orally once daily in 28-day cycles, and have completed a minimum of
3 cycles of treatment.
About CYT387:
CYT387 is an inhibitor of the kinase enzymes JAK1 and JAK2, 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. The U.S. Food and Drug Administration (FDA) has
granted Orphan Drug Designation to CYT387 for the treatment of
myelofibrosis.
YM BioSciences retains full global
commercialization rights to CYT387.
For more information on the CYT387 Phase I/II
trial, go to:
http://clinicaltrials.gov/ct2/show/NCT00935987?term=cyt387&rank=1
About YM BioSciences
YM BioSciences Inc. is a drug development company advancing three
clinical-stage products: CYT387, a small molecule, dual inhibitor
of the JAK1/JAK2 kinases; nimotuzumab, an EGFR-targeting monoclonal
antibody; and CYT997, a potent vascular disrupting agent (VDA).
CYT387 is an orally administered inhibitor of
both the JAK1 and JAK2 kinases, which have been implicated in a
number of immune cell disorders including myeloproliferative
neoplasms and inflammatory diseases as well as certain cancers.
CYT387 is currently in a Phase I/II trial in myelofibrosis.
Nimotuzumab is a humanized monoclonal antibody targeting EGFR with
an enhanced side effect profile. Nimotuzumab is being evaluated in
various Phase II and III trials worldwide by YM's licensees. CYT997
is an orally-available small molecule therapeutic with dual
mechanisms of vascular disruption and cytotoxicity, and is
currently in a Phase II trial for glioblastoma multiforme. In
addition to YM's three clinical stage products, the Company has a
library of more than 4,000 novel compounds identified through
internal research conducted at YM BioSciences Australia which are
currently being evaluated.
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 nimotuzumab will continue to
demonstrate a competitive safety profile in ongoing and future
clinical trials; that our JAK1/JAK2 inhibitor CYT387 and our VDA
small molecule CYT997 will generate positive efficacy and safety
data in future clinical trials; that YM and its various partners
will complete their respective clinical trials 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.