YMB YM Bio.'b'ser1

    YM BioSciences announces independent Data Safety Monitoring Board recommends
tesmilifene pivotal trial continue as planned

    MISSISSAUGA, ON, Aug. 22 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), a company engaged in the acquisition, development and
commercialization of oncology and acute care products, today announced that
the independent Data Safety Monitoring Board (DSMB) for the pivotal Phase III
trial of tesmilifene in metastatic and recurrent breast cancer has completed
its second planned safety and efficacy analysis following 256 events and
concluded that the trial should continue as planned.
    "We are encouraged by the DSMB's conclusion that our pivotal Phase III
trial should proceed," said David Allan, Chairman and CEO of YM BioSciences.
"Based on the study design, we believe the trial continues to have the
prospect to yield a positive outcome. Further, this analysis also confirms
that tesmilifene continues to demonstrate a good safety profile."
    The pivotal Phase III trial compares the survival of patients treated
with tesmilifene combined with epirubicin/cyclophosphamide to
epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic
and/or recurrent breast cancer. The trial, which completed enrollment of 723
patients in September 2005, is the subject of a Special Protocol Assessment
and a Fast Track designation for advanced breast cancer by the FDA.
    The trial is being conducted according to a sequential design that
permits a number of analyses and the trial will continue until one of two
specific statistical conditions is satisfied. At each analysis, the hazard
ratio between the tesmilifene-containing treatment arm and the control arm is
calculated and then reviewed by the DSMB, and the trial may be concluded if
either the tesmilifene-containing treatment arm is superior to the control by
a specified margin or it is determined that such evidence is not going to be
found. If the evidence is insufficient for either conclusion to be drawn, then
the trial continues until the next analysis. The third analysis is expected to
occur in Q3/Q4 2006 although, based on the data available to date, it is not
possible to determine exactly when it will occur nor do the available data
permit an accurate prediction of the outcome of the trial.

    About YM BioSciences
    YM BioSciences Inc. is engaged in the acquisition, development and
commercialization of oncology and acute care products.
    Tesmilifene is a small molecule MDR-targeting agent that is being tested
in combination with various standard chemotherapy regimens for the treatment
of a number of cancers. In addition to the Phase III DEC trial combining
tesmilifene with an anthracycline a collaborative trial with Sanofi-Aventis is
currently ongoing combining tesmilifene with Taxotere(R) (docetaxel) a taxane
drug. A trial combining tesmilifene with epirubicin, cyclophosphamide, and
5-FU is anticipated for the treatment of gastric cancer and additional trials
are in planning.
    In addition, YM BioSciences is developing nimotuzumab, AeroLEF(TM) and
Norelin.
    Nimotuzumab is an anti-EGFR humanized antibody that was recently
partnered in Japan with Daiichi Pharmaceutical Co., Ltd. Nimotuzumab was
approved in India in July 2006 for the treatment of head & neck cancer, is
currently in a Phase I/II trial in a specific population of patients with
non-small cell lung cancer in Canada and a Phase IIl trial in Europe in
combination with radiation for the treatment of pediatric pontine glioma.
    AeroLEF(TM) is a unique inhaled-delivery composition of free and liposome
encapsulated fentanyl, for the treatment of moderate to severe acute pain,
including cancer pain. AeroLEF(TM) is currently enrolling post-surgical
patients in a randomized Phase IIb trial.
    Norelin, an anti-cancer vaccine, stimulates the immune system to develop
antibodies to gonadotropin-releasing hormone (GnRH). In addition, YM
BioSciences also owns a portfolio of pre-clinical compounds

    Except for historical information, this press release may contain
forward-looking statements, which reflect the Company's current expectation
regarding future events. These forward-looking statements involve risk and
uncertainties, which may cause 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.
    
For further information: Thomas Fechtner, The Trout Group LLC, Tel. (212)
477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com; James
Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,
Email: jsmith(at)equicomgroup.com
(YMBA)


 



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