Regulatory Approval

    YM BioSciences Cleared to Initiate Clinical trial of Nimotuzumab in colorectal
Cancer

    MISSISSAUGA, ON, June 4 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today announced that it has
received a No Objection Letter from Health Canada to initiate the planned
Phase II trial investigating nimotuzumab in colorectal cancer patients who
have failed previous irinotecan-containing regimens. Nimotuzumab is a
humanized monoclonal antibody that targets the epidermal growth factor
receptor (EGFR).
    The single-arm trial will enroll approximately 100 patients in Canada who
will be treated with irinotecan plus nimotuzumab. Equal cohorts investigating
two dosing schedules will be enrolled. Recruitment of the first cohort is
expected to be completed within approximately 12 months from initiation
following which data on the primary endpoint - response rate - will be
reported.
    "As colorectal cancer is the second leading cause of cancer death in
North America, this trial could generate important data for expanding the
prospective market for nimotuzumab," said David Allan, Chairman and CEO of
YM BioSciences. "Other EGFR targeting antibodies have shown efficacy and been
approved for treating this form of cancer. We are optimistic that this trial
will give preliminary evidence that our EGFR antibody has the prospect for
being as effective in response rates while providing a superior safety profile
compared to other drugs in its class, as has been consistently seen in
previous trials."
    Nimotuzumab is approved for sale in India and China as well as certain
Latin American countries for the treatment of head and neck cancers. It
continues to be differentiated from the other antibodies and small molecules
targeting the tyrosine kinase pathway as treatment with the other drugs in
this class may result in the debilitating and unpleasant side-effects of
severe rash, conjunctivitis, painful paronychial inflammation, hypomagnesemia,
diarrhea and constipation. Such side-effects have rarely been reported in
patients treated with nimotuzumab.
    YM BioSciences has previously announced its intention to also file for
trials with nimotuzumab in pediatric pontine glioma, and esophageal cancer
during 2007. Nimotuzumab has been sub-licensed by YM to Daiichi Sankyo Co.,
Ltd for Japan and to other companies advancing the drug in Taiwan, Indonesia,
and Korea. Oncoscience AG, the European licensee, advised YM that it expects
to complete enrollment in its Phase III trial in pediatric pontine glioma in
the coming months. YM also recently announced the receipt of a No Objection
Letter from Health Canada and a positive certificate of inspection from a
competent authority in the EU for the scaled-up manufacturing of the drug at
the Center of Molecular Immunology and also announced an expected further
doubling of manufacturing capacity at that facility during 2007.

    About YM BioSciences

    YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two late-stage products: nimotuzumab, a humanized monoclonal antibody that
targets the epidermal growth factor receptor (EGFR) and is approved in several
countries for treatment of various types of head and neck cancer; and
AeroLEF(TM), a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain.

    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; 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] x31, Fax [phone], Email:
tfechtner(at)troutgroup.com; James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Fax [phone], Email: jsmith(at)equicomgroup.com
(YM. YMI YMBA)

 



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