YM BioSciences announces termination of the tesmilifene Phase III pivotal trial in advanced breast cancer



    
    - The Data Safety Monitoring Board advises the trial is very unlikely to
           demonstrate a survival benefit for the tesmilifene arm -

     -   Conference call scheduled for Wednesday, January 31, 8:30 a.m. ET -
    

    MISSISSAUGA, ON, Jan. 30 /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 the
independent Data Safety Monitoring Board (DSMB) for the pivotal Phase III
trial of tesmilifene in patients with metastatic or recurrent breast cancer
has completed its third planned safety and efficacy analysis. The DSMB advised
the Company to stop the trial based on an interim analysis of 351 events,
indicating it is very unlikely significant differences in overall survival
will be shown between treatment arms as the data mature. The trial was not
stopped due to safety concerns relating to the product. The Company plans to
submit data from this trial to an appropriate medical meeting after it
completes its review.
    Dr. Joyce A. O'Shaughnessy, a leading breast cancer researcher,
oncologist and the designated Safety Officer of the DSMB, and Professor
Lee-Jen Wei, Chair and Statistician of the DEC Trial Data Safety Monitoring
Board stated that, "We extend high praise to YM BioSciences. The DSMB is of
the opinion that the trial was well-conducted and well-executed."
    The pivotal Phase III trial compared 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 study, which completed enrollment of 723
patients in September, 2005, was the subject of a Special Protocol Assessment
and a Fast Track designation for advanced breast cancer by the U.S. Food and
Drug Administration (FDA).
    "We are very disappointed by this outcome and will be evaluating the data
to understand why tesmilifene did not add a clinical benefit in this trial,"
said David Allan, Chairman and CEO of YM BioSciences. "Upon completing the
review of the Phase III data, the Company will consider its options relating
to tesmilifene.
    In the meantime, we are fortunate to have two other late-stage products
which we expect to make important progress this year. Nimotuzumab is our
humanized antibody targeting the epidermal growth factor receptor and has
shown a more favorable safety profile in studies to date than currently
approved products in that family. We also have AeroLEF(TM), an inhaled
composition of free and liposome-encapsulated fentanyl, which is unique in its
ability to enable patients to individualize their dose to their pain level."
    The trial was conducted according to a sequential design that permitted a
number of planned interim analyses while the trial continued until one of two
specific statistical conditions was satisfied. At each analysis, survival for
the tesmilifene-containing treatment arm and the control arm was calculated
and then reviewed by the DSMB. The trial was to be concluded if either the
tesmilifene-containing treatment arm was superior to the control by a
specified margin or it was determined that such evidence was not going to be
found. After the third planned analysis, the DSMB concluded that the trial was
highly unlikely to achieve a pre-specified survival benefit.

    About Tesmilifene

    Tesmilifene is a novel, small molecule that selectively targets
multiple-drug resistant (MDR) tumor cells, sensitizing them to chemotherapy.
Tesmilifene may offer clinical benefit in a number of tumor types and is being
tested with a variety of chemotherapeutic regimens. In addition to the current
pivotal trial, a Phase III trial of tesmilifene with doxorubicin in metastatic
or recurrent breast cancer has been completed and a Phase II study to evaluate
tesmilifene plus docetaxel (Taxotere(R)) in patients with metastatic breast
cancer is being conducted in collaboration with Sanofi-Aventis. In
hormone-refractory prostate cancer (HRPC), two single-arm Phase II trials of
tesmilifene in combination with chemotherapy (one with mitoxantrone plus
prednisone; the other with cyclophosphamide) and a randomized Phase II trial
comparing cyclophosphamide alone to cyclophosphamide plus tesmilifene have
been conducted. Based on the clinical data generated from these three studies,
the Company is currently evaluating additional clinical work in patients with
HRPC. In addition, the Company and its partners are evaluating clinical
studies in patients with gastric cancer as well as patients with hepatic
cancer.

    About YM BioSciences

    YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. In addition to
tesmilifene, the Company has two other late-stage products. Nimotuzumab is 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. Its in clinical trials in numerous tumor types
including glioma (pediatric and adult), pancreatic cancer, prostate cancer,
non-small cell lung cancer, esophageal cancer, cervical cancer and breast
cancer. AeroLEF(TM), a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl is in development for the treatment of moderate
to severe pain.

    Conference Call Scheduled

    A conference call is planned for 8:30 a.m. ET, on Wednesday, January 31,
2007, to which participants may listen via an audio webcast, accessible
through the company's website at www.ymbiosciences.com or via telephone. The
telephone conference number is 416-644-3416 or toll-free at 1-800-589-8577.

    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 the pivotal tesmilifene Phase III trial will be completed
on schedule and yield mature data in calendar 2007; that the DSMB's
recommendations to terminate the pivotal trial for tesmilifene based on three
planned interim analyses implies that the trial was very unlikely to meet its
primary endpoint; that nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; 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: Investor Relations U.S.: Thomas Fechtner, The
Trout Group LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028, Email:
tfechtner@troutgroup.com; Investor Relations Canada: James Smith, the Equicom
Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080, Email:
jsmith@equicomgroup.com; Media Enquiries: Mike Beyer, Sam Brown Inc., (773)
463-4211, Email: beyer@sambrown.com


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