YM BioSciences Initiates Patient Enrolment

    YM BioSciences Initiates Patient Enrolment In Phase II Colorectal Cancer Trial
With EGFR Antibody

    MISSISSAUGA, ON, July 31 /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
enrolled the first five patients within the 50-patient initial cohort of its
Phase II trial with nimotuzumab in combination with irinotecan for the
treatment of patients with colorectal cancer who have previously failed
irinotecan-containing regimens. Recruitment of the first cohort is expected to
be completed within approximately eight months, following which data on the
primary endpoints, response rate and safety, will be reported.
    The single-arm trial will enroll approximately 100 patients in Canada.
The trial will enroll two 50-patient cohorts consecutively, with the first
cohort receiving irinotecan on one of the conventional dosing schedules with
weekly dosing of nimotuzumab and the second cohort receiving irinotecan on one
of the conventional dosing schedules with nimotuzumab every two weeks. The
first patient was enrolled into the study at the Southlake Regional Health
Centre in Ontario under the principal investigator Dr. Labib Zibdawi. The
study principal investigator is Dr. Amil Shah at the BC Cancer Agency in
Vancouver. Fourteen sites across Canada are expected to participate in the
trial of which two sites are currently open.
    "We are very pleased with the enthusiasm of the investigators and the
initial rate of enrollment, giving us confidence that data will be available
within 12 months. Initiating this trial is another important milestone in our
strategy to develop nimotuzumab on a global basis for a broad range of cancer
indications," said David Allan, Chairman and CEO of YM BioSciences. "Results
from this trial could further continue to confirm the unique safety profile of
our EGFR-targeting antibody while establishing its efficacy, and expanding the
prospective market for nimotuzumab into one of the largest cancer patient
populations."
    Colorectal cancer is the second leading cause of cancer death in North
America, and the leading cause of cancer death in non-smokers.
    YM BioSciences has previously announced its intention to initiate a trial
with nimotuzumab in pediatric glioma, for which it has received clearance from
Health Canada. Recruitment in a Phase I trial in patients with non-small-cell
lung cancer (NSCLC), who are unfit for radical chemotherapy and who are being
treated with nimotuzumab and radiation, is nearing completion in Canada and
continues in the arm of the trial being conducted in Korea. A Phase II
extension to this trial is planned to be initiated in Canada early in 2008.
Preliminary data on the efficacy and safety of this combination is also
anticipated toward calendar year-end. YM recently announced results of a study
presented at The Japanese Association for Molecular Target Therapy of Cancer
demonstrating that nimotuzumab increased the radio-sensitivity of human NSCLC
cell lines both in vitro and in vivo, further supporting previous clinical
observations of the effect of nimotuzumab with radiation in other cancers.
    Development of the drug continues in the worldwide consortium of
nimotuzumab licensees. In Europe, Oncoscience AG anticipates the completion of
enrollment in a Phase III first-line trial of children and adolescents with
diffuse, intrinsic pontine glioma and has advised that it also proposes to
file for two randomized Phase III trials, in grade IV adult glioma and
advanced or metastatic pancreatic cancer respectively, in Q3, 2007. Daiichi
Sankyo, YM BioSciences' partner in Japan, continues recruitment in its Phase I
safety trial in various tumours in anticipation of launching a number of Phase
II trials during 2008. YM anticipates that a number of the licensees for
nimotuzumab will participate together in cooperative trials during 2008 for
the purpose of optimizing recruitment rates and reducing costs for each
participating member.

   
About nimotuzumab

    Nimotuzumab is a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR). 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.
    Nimotuzumab has been sub-licensed by CIMYM BioSciences, a subsidiary of
YM, to Daiichi Sankyo Co., Ltd for Japan and to other companies advancing the
drug including Oncoscience AG in Europe, Kuhnil Pharmaceutical Co. in South
Korea and Innogene Kalbiotech Ltd. in Southeast Asia. Nimotuzumab is approved
for sale in India and China as well as certain Latin American countries for
the treatment of head and neck cancers.

    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; that AeroLEF(TM) 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] 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)



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