- Poster with broader update of trial results to be presented at ASCO -
MISSISSAUGA, ON, May 18 /CNW/ - YM BioSciences Inc. (NYSE Amex: YMI) (TSX: YM), today reported updated interim results for the first 60 patients with
high/intermediate-risk myelofibrosis who have completed a minimum of
three cycles of treatment (12 weeks) in its ongoing Phase I/II
"In addition to reducing spleen volumes and improving constitutional
symptoms, CYT387 continues to demonstrate the ability to induce durable
anemia responses in a significant number of patients with transfusion
dependency associated with myelofibrosis," said Dr. Nick Glover,
President & CEO of YM BioSciences.
These results were submitted to the 2011 Annual Meeting of the American
Society of Clinical Oncology (ASCO) as an abstract in February 2011.
Study Investigators will present additional updated information from
the study in a poster session at ASCO on June 3rd from 2:00-6:00pm. CYT387 was administered orally once daily in 28-day
cycles. Responses were assessed by International Working Group (IWG)
criteria. Forty-two of the 60 patients were evaluable for anemia
response per IWG criteria (Blood 2006;108:1497) and 33 of these were red cell transfusion-dependent. In
the latter group, anemia response required a transfusion-free period of
≥12 weeks, while on protocol drug therapy, and capped by a hemoglobin
level of ≥8 g/dL.
The anemia response rate was 50% overall and 58% in
At the time the abstract was submitted, the median duration of anemia
response was 20 weeks (range 12-54 weeks) and only two (11%) of the 19
patients who achieved transfusion-independency required single episodes
of PRBC transfusions. As previously announced, at the First Annual
Florence Meeting on Myeloproliferative Neoplasms held in Florence,
Italy on April 16, 2011 an updated median duration of transfusion
independence was reported by Study Investigators to be six months
(range 4-15 months).
Responses in anemia were not affected by leukocyte count (p=0.39),
platelet count (p=0.35), circulating blast count (p=0.35), circulating
CD34 cell count (p=0.78), karyotype (p=0.67) or JAK2V617F mutational status (p=0.17).
Spleen response rate by IWG criteria was approximately 45%.
The majority of patients experienced resolution of constitutional
symptoms including pruritus, night sweats and bone pain.
The study retention rate after a median treatment duration of 6.4 months
Grade 3/4 hematologic and non-hematologic adverse events were infrequent
with the exception of thrombocytopenia, which occurred in approximately
25% of patients (platelet inclusion criteria: 50,000/µl).
About half of the patients experienced a first-dose effect (transient
lightheadedness and Grade 1 hypotension), which was self-limited and
generally resolved within hours with rare recurrence.
Enrollment in the trial has currently exceeded the initial target of 140
patients and is expected to close in calendar Q2 2011 and include
approximately 155 patients. YM anticipates that more mature data from
the full trial will be reported by the end of calendar 2011.
Notice of YM Analyst/Investor Event at ASCO:
YM BioSciences will host an Analyst/Investor event on Friday, June 3,
2011 from 6:30-8:30pm where Management will discuss the results
presented at ASCO. The event will be held at The Wheeler Mansion in
Chicago, IL. To attend the event, please RSVP at http://www.troutgroup.com/ymasco.aspx
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 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 over
currently marketed EGFR-targeting antibodies. Nimotuzumab is being
evaluated in numerous Phase II and III trials worldwide. CYT997 is an
orally-available small molecule therapeutic with dual mechanisms of
vascular disruption and cytotoxicity, and has completed 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 CYT387,
nimotuzumab and CYT997 will generate positive efficacy and safety data
in ongoing and future clinical trials, and that YM and its various
partners 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.
For further information:
VP Corporate Communications
YM BioSciences Inc.
Tel. +1 905.361.9518