- Poster with broader update of trial results to
be presented at ASCO -
MISSISSAUGA, ON, May 18 /PRNewswire-FirstCall/ - 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 multi-center
study.
"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.
Efficacy Results:
- The anemia response rate was 50% overall and 58% in
transfusion-dependent patients.
- 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.
Safety Results:
- The study retention rate after a median treatment duration of
6.4 months was 92%.
- 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
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 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.