YM BIOSCIENCES REPORTS DAIICHI-SANKYO ENROLLS FIRST PATIENTS IN PHASE II, FIRST-LINE LUNG CANCER TRIAL WITH NIMOTUZUMAB



    MISSISSAUGA, ON, June 23 /CNW/ - YM BioSciences Inc. (NYSE Amex:  YMI,
TSX:YM, AIM:YMBA), a life sciences product development company that identifies
and advances a diverse portfolio of promising cancer-related products at
various stages of development, today reported that its licensee for
nimotuzumab, Daiichi-Sankyo Co., Ltd. in Japan advises that it has commenced
enrollment of a Phase II trial evaluating nimotuzumab in combination with
radiation therapy/cisplatin/vinorelbine in first-line curative intent patients
with Stage III non-small-cell lung cancer (NSCLC). The trial will evaluate the
treatment completion rate and numerous secondary endpoints including response
rate, progression-free survival, and the overall survival rate at 12 and 18
months as well as toxicity.
    "This is the latest of eleven Phase II and III trials currently being
conducted by YM and/or its four licensees, highlighting the tremendous breadth
of clinical activity focused on nimotuzumab and the benefits of our
cooperative model which permits the undertaking of such a comprehensive
international program," said David Allan, Chairman and CEO of YM BioSciences.
"Of these trials, three involve patients with NSCLC at various stages -
curative, palliative radiotherapy and metastatic. NSCLC is an important
indication for nimotuzumab as treatments typically involve
radiation-containing regimens that have been demonstrated to enhance the
expression of EGFR. Nimotuzumab's differentiated mechanistic attributes result
in it selectively targeting tissues over-expressing EGFR while avoiding normal
tissue. The debilitating and dangerous side effects observed with the marketed
EGFR-targeted drugs result from their indiscriminant targeting of normal
healthy tissues in addition to their binding to tumor."
    YM and its licensee Kuhnil Pharmaceutical Co. in Korea recently
collaborated on a Phase I trial treating patients with palliative radiotherapy
for NSCLC. The data from the Canadian arm of the trial were presented at ASCO
2008 and indicated that the combination of nimotuzumab with radiation was
feasible and safe and has the potential to provide an important quality of
life and survival advantage to patients over radiation alone in the palliative
setting. Continued treatment for prolonged periods was very well tolerated and
there was no evidence of Grade III or IV rash at any of the three dose levels
nor did nimotuzumab increase the toxicity of radiotherapy. Based on these
results, YM is currently conducting an international 128-patient Phase II
randomized, double-blind, placebo-controlled study that will examine the
effect of nimotuzumab when added to palliative radiotherapy to treat NSCLC.
The incidence of NSCLC exceeds 367,000 new cases each year in the seven major
pharmaceutical markets.
    YM licensees Daiichi and Kuhnil are currently collaborating on a Phase II
randomized, open-label trial they are conducting evaluating nimotuzumab plus
irinotecan compared to irinotecan alone in patients with advanced or recurrent
gastric cancer who are refractory to 5-FU-containing regimens. The licensees
report enrollment continues to progress and remains on track to be completed
in calendar 2009.
    Results were reported recently at the 2009 ASCO Annual Meeting from a
randomized Phase IIb, four-arm, open-label trial of nimotuzumab in combination
with radiation therapy (RT) or chemoradiation therapy (CRT) in patients with
inoperable, locoregionally advanced Stage III/IVa head and neck cancer
conducted in India by Reddy BK et al. The addition of nimotuzumab to both the
RT and CRT regimens improved the overall response rate, survival rate at 30
months, median progression-free survival and median overall survival. A
combined group analysis of the nimotuzumab arms vs. the non-nimotuzumab arms
demonstrated a significant difference in overall survival (p = 0.0018)
favoring nimotuzumab. The addition of nimotuzumab did not add to the
toxicities of either regimen, with no Grade III/IV skin toxicities observed.
The trial demonstrates that the efficacy of nimotuzumab compares favorably to
results reported for cetuximab, an EGFR-targeting antibody marketed as
Erbitux(R), but that this efficacy was not accompanied by the severe
toxicities reported in patients treated with cetuximab.
    YM BioSciences today posted a series of documents on its website,
www.ymbiosciences.com that address frequently asked questions made by the
investment community and pharmaceutical industry relating to YM's products and
business strategy. A comprehensive description of the completed and ongoing
trials being conducted by YM and the other licensees of nimotuzumab is also
available at YM's website.

    About YM BioSciences

    YM BioSciences Inc. is a life sciences product development company that
identifies and advances a diverse portfolio of promising cancer-related
products at various stages of development. The Company is currently developing
two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized
Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of
free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical
trial expertise and a diversified business model designed to reduce risk while
advancing clinical products toward international approval, marketing and
commercialization.
    Nimotuzumab is a humanized monoclonal antibody in development worldwide,
targeting multiple tumor types primarily in combination with radiation and
chemoradiation. It is significantly differentiated from all other currently
marketed EGFR-targeting agents due to its remarkably benign side-effect
profile. Nimotuzumab's anti-tumor activity has led to its approval for
marketing in more than 12 countries. In more than 3,500 patients reported as
having been treated with nimotuzumab worldwide to date, no Grade IV incidents
of radiation dermatitis have been described, severe rash has not been observed
and reports of the other severe side-effects that are typical of
EGFR-targeting molecules have been rare. Nimotuzumab is licensed to YM's
majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was
developed at the Center of Molecular Immunology. YM is developing AeroLEF for
the treatment of moderate to severe acute pain. The product is differentiated
from other approaches using fentanyl because patients can individually control
the analgesia required for their differing intensities of pain. AeroLEF met
all endpoints in a randomized Phase II trial and is currently being prepared
for late-stage development internationally.

    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 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 AeroLEF(R) will
continue to generate positive efficacy and safety data in future clinical
trials; and that YM and its various partners will complete their respective
clinical trials within the timelines communicated in this release. We
undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.

    %SEDAR: 00004652E




For further information:

For further information: James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Email: jsmith@equicomgroup.com; Thomas Fechtner, the Trout
Group LLC, Tel. (646) 378-2931, Email: tfechtner@troutgroup.com; Nominated
Adviser: Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500


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