Research Update

    YM BIOSCIENCES REPORTS DATA FROM EXPLORATORY CLINICAL TRIALS OF NIMOTUZUMAB IN
BRAIN METASTASES AND HIGH-GRADE GLIOMA PRESENTED AT 2008 EORTC-NCI-AACR ANNUAL
MEETING

    MISSISSAUGA, ON, Nov. 3 /CNW/ - YM BioSciences Inc. (NYSE Alternext
US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today announced
data from two clinical trials of nimotuzumab, its humanized monoclonal
antibody that targets the epidermal growth factor receptor (EGFR). Preliminary
results from the two trials which are evaluating nimotuzumab in combination
with radiation therapy for the treatment of brain metastases and high-grade
gliomas, conducted by YM's licensor, were presented at the 2008 EORTC-NCI-AACR
annual meeting recently held in Geneva, Switzerland.
    "YM's program for registration of nimotuzumab is focused on cancers that
are typically treated with radiation-containing regimens and will target brain
metastases as one of its initial indications. These data further support this
strategy and have served to reinforce the designs of our upcoming trials for
this drug," said David Allan, Chairman and CEO of YM BioSciences.

    Phase II Brain Metastases Trial - Preliminary Results

    In the poster entitled "Preliminary results of a phase II clinical trial
of the anti EGFR monoclonal antibody nimotuzumab in combination with whole
brain radiation therapy in patients diagnosed with advanced non-small cell
lung cancer (NSCLC) and unresectable brain metastases", data were reported for
a randomized, open controlled trial of 30 patients who received nimotuzumab
(200 mg administered as weekly IV infusions over weeks 1-6) plus palliative
radiation (40 Gy in four weeks) or palliative radiation alone. The primary
endpoint was disease control rate (DCR (equal sign) Complete Response +
Partial Response + Stable Disease) and secondary endpoints included overall
survival and safety.
    The poster reports data from the first 21 patients. DCR was 91.6% for the
nimotuzumab plus radiation arm compared to 44.4% for the radiation alone arm.
Patients treated with the combination had a mean and median survival of 7.32
and 7.00 months respectively (five patients still alive), compared to the
control group for whom the mean and median survival was 3.03 and 2.47 months
respectively (one patient still alive). This difference reached statistical
significance (p(equal sign) 0.0039, Log Rank test).
    "In this exploratory study, nimotuzumab administered concurrently with
whole brain radiation therapy yielded substantial radiological responses and
meaningful clinical responses in these late-stage patients. Furthermore,
consistent with all other trials to date, nimotuzumab did not provoke skin
rash or GI adverse events," noted Dr. Leonardo Viana Nicacio, Director of
Clinical Affairs for YM BioSciences. "While this was only a modestly sized
study, we believe it provides a reasonable indication of the potential value
of the combination of nimotuzumab and radiation for the treatment of brain
metastases."

    Phase II High Grade Glioma Trial - Preliminary Results

    In a poster entitled "Use the humanized anti-EGFR MAb (nimotuzumab) and
irradiation for the treatment of high grade glioma patients", data were
reported for a randomized 80 patient multi-centre double-blind Phase II/III
clinical trial evaluating the efficacy and safety of nimotuzumab in
combination with radiotherapy in newly diagnosed high-grade glioma patients.
Patients received six weekly infusions of placebo or nimotuzumab (200 mg)
while receiving radiotherapy, followed by a maintenance dose of nimotuzumab or
placebo every 21 days until completing a year of treatment. All patients had
surgery (biopsy, partial or total resection) before the inclusion in the
trial. To date, 65 patients have been enrolled, 30 patients with glioblastoma
and 35 with anaplastic astrocytomas. With enrollment of the glioblastoma group
complete, results of a preliminary evaluation of safety and survival were
reported.
    The antibody was very well tolerated and did not provoke skin rash or
allergic reactions. A preliminary survival analysis was conducted for all
subjects with anaplastic astrocytoma and glioblastoma multiforme that received
adjuvant radiotherapy. The mean and median survival time for the patients
treated with nimotuzumab plus radiotherapy was 14.31 and 16.43 months,
respectively, while the mean and median survival time for the placebo arm was
8.67 and 10.49 months. The median survival time is similar to that reached in
a prior, single-arm study in patients with glioblastoma treated with
nimotuzumab and radiotherapy (17.43 months).

    About Nimotuzumab

    Nimotuzumab is being developed to compete as best-in-class therapy
against the currently marketed EGFR-targeting drugs. This drug has displayed
efficacy in numerous clinical trials with anti-cancer activity that rivals the
other EGFR-targeting antibody drugs. However, in none of its trials to date,
to YM's knowledge, have any of the patients treated with nimotuzumab had Grade
III/IV rash, a severe and dose-limiting side-effect observed in all of the
other antibodies and with small molecules targeting the EGF tyrosine kinase
signaling pathway. Reports of any severe incidents of the other side-effects
that are typical of EGFR-targeting molecules have been rare. Unlike cetuximab,
nimotuzumab patients do not have to be pre-medicated to prevent infusion
reactions.
    YM and its direct licensees have studies underway and others in planning
that investigate nimotuzumab in settings where regimens that stimulate EGFR
activated expression are used, such as radiation or chemoradiation.

    About YM BioSciences

    YM BioSciences Inc. is a company that identifies, develops and
commercializes differentiated products principally in the area of oncology for
patients worldwide. The Company is developing nimotuzumab, a humanized
monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery
composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in
development targeting multiple tumour types in combination with radiation,
chemoradiation and chemotherapy. The drug, which is approved for marketing in
eight countries, is significantly differentiated from all other currently
marketed EGFR-targeting agents because of a remarkably benign side-effect
profile. In approximately 3,000 patients treated worldwide, to date, no Grade
III/IV rash has been reported and reports of any of the other side-effects
that are typical of EGFR-targeting molecules have been rare. AeroLEF(R) is in
development for the treatment of moderate to severe pain, including cancer
pain. The product completed a randomized trial in 2007 and is 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.

For further information: Enquiries: Thomas Fechtner, the Trout Group LLC,
Tel. [phone], Email: tfechtner(at)troutgroup.com; James Smith, the
Equicom Group Inc., Tel. [phone] x 229, Email:
jsmith(at)equicomgroup.com; Nominated Adviser, Canaccord Adams Limited, Ryan
Gaffney, Tel. [phone]
(YM. YMI YMBA)

 



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