YM BioSciences Inc. (YMI)

[Harleyman]

News for 'YMI' - (YM BioSciences Reports Updated Phase I/II Data for its JAK1/JAK2 Inhibitor CYT387 at ASH 2011)


MISSISSAUGA, ON, Dec. 12, 2011, 2011 (Canada NewsWire via COMTEX) -- -
Significant and durable responses in anemia, splenomegaly and constitutional
symptoms reported - - Well tolerated for dosing periods up to and exceeding two
years - - MRI results confirm meaningful improvements in splenomegaly -

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), today reported updated results
from the ongoing Phase I/II study of its JAK1/JAK2 inhibitor, CYT387, for the
treatment of myelofibrosis. The results are being presented this evening in a
poster session at the 53rd Annual Meeting of the American Society of Hematology
underway in San Diego, CA.

"In this multicenter study, CYT387 continues to demonstrate a unique ability to
render and maintain myelofibrosis patients transfusion independent for
clinically-relevant periods, while also producing significant and durable
improvements in their splenomegaly and constitutional symptoms," said Dr. Nick
Glover, President and CEO of YM BioSciences. "In addition, MRI results obtained
from a subset of subjects confirm the meaningful improvements in splenomegaly as
measured by palpation. Moreover, CYT387 was well tolerated, with dosing up to
and exceeding two years."

"While additional assessments and analyses are ongoing across dose levels, 300
mg/day appears to be a safe and effective dosing regimen that warrants further
clinical development," added Dr. Glover. "We look forward to leveraging these
data to advance our regulatory strategy and our business development activities
with the goal of starting pivotal trials in mid-2012."

Phase I/II Study Updated Results

Study Design The Core Phase I/II study has completed enrollment of 166
myelofibrosis patients across six study sites. The Core study consists of nine
28-day treatment cycles where CYT387 is orally self-administered, primarily at
dosages of 150 mg once-daily (QD), 300 mg QD or 150 mg twice-daily (BID).
Patients who tolerate and benefit from the drug may continue to receive CYT387
beyond the Core study in an Extension phase. While data collection and analysis
are ongoing, preliminary safety and efficacy results from this multicenter study
are presented below.

Subject Characteristics The majority of the 166 patients enrolled have Primary
Myelofibrosis (65%); 22% have Post-Polycythemia vera and 14% have Post-Essential
thrombocythemia. Other patient characteristics include:





-- DIPSS-Plus category: Int-1 - 11%; Int-2 - 61%; High - 28%

-- JAK2V617F positive: 76%

-- Red blood cell transfusion-dependent: 44%

-- Palpable splenomegaly >10 cm: 80%





The trial also enrolled patients who had received previous therapies, including
other JAK inhibitors (12%) and IMiDs (9%).

Subject Disposition The median follow-up time for patients in the Core study and
Extension phase is 10.4 months (range: 0.8-25.6 months; ongoing). To date, 97%
of patients who have completed the Core study have continued into the Extension
phase. During the Core study, 32 patients (19%) have discontinued the study,
five for possibly or probably related adverse events, for a current overall
retention rate of 81%. The retention rate during the Extension phase is
currently 79%.

Anemia Response Of the 68 patients who were transfusion dependent at baseline,
to date 54% have become transfusion independent for a minimum of 12 weeks. The
median duration of the transfusion-free period has not yet been reached (range:
82-506 days, ongoing). More than 25% of subjects who were not receiving
transfusions while on study experienced at least a 1 g/dL increase in hemoglobin
lasting for more than eight weeks.

Of the 26 patients who were dosed at 300mg QD and were transfusion dependent at
baseline, to date 65% have become transfusion independent for a minimum of 12
weeks.

Spleen Response Of the 142 patients evaluable for spleen response, 31% achieved
a response per IWG-MRT*. The median duration of spleen response has not yet been
reached (range: 55 - 574 days, ongoing). The median time to spleen response was
15 days (range: 6 - 260 days, ongoing). To date, 49% of patients achieved more
than a 50% maximal decrease in spleen size from baseline, with 87% achieving
more than a 25% maximal decrease.

Of the 51 patients who were dosed at 300mg QD and were evaluable for spleen
response, 33% achieved a response per IWG-MRT.

Eleven patients were evaluable for spleen response both by MRI and by palpation.
The response rate was 64% by MRI (defined as a 35% decrease in spleen volume)
and 45% by palpation (defined as a 50% decrease in spleen length). The median
splenic decrease from baseline at three months was -41% by volume measured by
MRI and -45% by length measured by palpation.

*International Working Group for Myelofibrosis Research and Treatment

Constitutional Symptoms Response The majority of patients reporting
constitutional symptoms at baseline demonstrated a Complete Resolution or Marked
Improvement of their symptoms, including night sweats, pruritus and bone pain.

Safety Results CYT387 is well tolerated in myelofibrosis patients for dosing
periods up to and exceeding two years. Reported adverse effects include
thrombocytopenia; transient, mild dizziness; mild peripheral neuropathy; and
abnormalities in liver/pancreas-related laboratory tests. Treatment emergent
anemia and neutropenia were rarely reported.

Poster presentation and YM conference call: The updated results from the Phase
I/II study will be presented in a poster session at the 53rd Annual Meeting of
the American Society of Hematology. Poster #3849, entitled "Safety and Efficacy
of CYT387, a JAK1 and JAK2 Inhibitor for the Treatment of Myelofibrosis", will
be presented at Session #634, Myeloproliferative Syndromes: Poster III, being
held on Monday, December 12th from 6:00-8:00pm PT in Hall GH of the San Diego
Convention Center.

YM will also host a webcast meeting open to members of the investment community
to discuss these results. This event will be held from 6:30-7:30am PT on
Tuesday, December 13th in the Grand Ballroom of the Hotel Palomar, 1047 Fifth
Avenue, San Diego. Access to the webcast will be available from YM's website at
www.ymbiosciences.com or at www.newswire.ca. The event can also be heard by
dialing in to [phone] or toll-free at [phone].

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.

Both the U.S. Food and Drug Administration (FDA) and the European Commission
have designated CYT387 an Orphan Drug for the treatment of myelofibrosis.

YM BioSciences retains full global commercialization rights to CYT387.

About YM BioSciences YM BioSciences Inc. is a drug development company advancing
three 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 166 patient Phase I/II trial in myelofibrosis
that has completed enrollment, as well as a 60 patient Phase II BID trial that
is recruiting patients. 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 in glioblastoma multiforme. In addition to YM's three products, the
Company has several preclinical research 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, nimotuzumab and CYT997 will generate positive efficacy
and safety data in ongoing and future clinical trials, and that YM and its
various licensees will complete their respective clinical trials and disclose
data within the timelines communicated in this release. Except as required by
applicable securitieslaws, we undertake no obligation to publicly update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.

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SOURCE: YM BioSciences Inc.