YM BioSciences Inc. (YMI)

[Harleyman]

News for 'YMI' - (YM BioSciences JAK Inhibitor CYT387 Produces Meaningful Reductions of Splenomegaly and Durable Transfusion Independence Responses)


MISSISSAUGA, ON, Nov. 5, 2012, 2012 (Canada NewsWire via COMTEX) -- 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.

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SOURCE: YM BioSciences Inc.