MISSISSAUGA, ON, April 18 /CNW/ - 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
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.
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:
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.
For further information:
VP Corporate Communications
YM BioSciences Inc.
Tel. +1 905.361.9518