YM BIOSCIENCES USA ENROLLS FIRST PATIENT IN PHASE II TRIAL OF NIMOTUZUMAB IN CHILDREN WITH INOPERABLE, RECURRENT BRAIN CANCER



    MISSISSAUGA, ON, Feb. 13 /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 its
wholly-owned US subsidiary, YM BioSciences USA Inc. ("YM-USA") has enrolled
the first patient in its Phase II trial investigating nimotuzumab in pediatric
patients with recurrent diffuse intrinsic pontine glioma (DIPG), a form of
inoperable, treatment-resistant brain cancer. The patient was treated at the
M.D Anderson Cancer Center under the care of Dr. Johannes Wolff. Nimotuzumab
is a humanized monoclonal antibody that targets the epidermal growth factor
receptor (EGFR).
    "We are very pleased that this trial is underway in the expectation that
nimotuzumab will benefit the children suffering from this insidious form of
brain cancer for which there are currently no effective treatments," said
David Allan, Chairman and CEO of YM BioSciences. "If nimotuzumab continues to
perform as it has in previous trials, it has the potential to improve clinical
outcomes and, particularly, without inflicting the serious side effects that
have been reported for the other drugs in its class."
    Eight leading US pediatric clinical centers and two Canadian centers will
be participating in the single-arm trial, which is designed to enroll 44
patients with DIPG who will be treated with nimotuzumab as monotherapy. The
primary endpoint of the current trial is Response Rate, with a target of 15%,
and recruitment is expected to be completed within approximately 18 months.
    Positive data from a completed Phase II nimotuzumab monotherapy trial in
Europe that included pediatric patients with this recurrent form of brain
cancer were reported in an oral presentation at ASCO, 2007. In the 21 patients
with DIPG, the clinical benefit rate, which included Partial Response and
Stable Disease, was 38% after eight weeks of treatment. Of the eight patients
who continued on treatment to week 21, three were assessed with a Partial
Response and one with Stable Disease. The Company is not aware of any previous
clinical trials that reported Objective Responses in recurrent DIPG.
    Recruitment in a Phase III trial combining nimotuzumab with radiation for
the first-line treatment of children with DIPG, conducted by Oncoscience AG
(YM's European licensee for nimotuzumab) was completed in August 2007. The
primary end-point of the Phase III trial is Progression-Free Survival with
Overall Survival as a secondary endpoint. YM anticipates that data from this
trial will be available mid-2008 and, if positive, are expected to be
supportive of an application in 2008 for marketing approval in Europe. An
application for marketing authorization of nimotuzumab based on earlier stage
data was submitted to EMEA by Oncoscience AG on October 4th, 2007.
    Nimotuzumab in combination with radiation-containing regimens has been
demonstrated to be effective in other indications for which it is already
approved in certain jurisdictions. The clinical benefit of nimotuzumab as
monotherapy in a range of patients refractory to all treatments was also
published in the proceedings at ASCO, 2007 in addition to the presentation of
the pediatric results.
    The US investigational trial sites participating in the international
Phase II trial include leading pediatric neuro-oncology centers that are
members of POETIC (Pediatric Oncology Experimental Therapeutics International
Consortium): Vanderbilt Children's Hospital/Vanderbilt-Ingram Cancer Center;
M.D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; the
Sidney Kimmel Cancer Center at Johns Hopkins; the Children's Hospital at the
University of Colorado and the University of Florida Children's Hospital. In
addition, the University of Rochester Medical Center and the New York
University Medical Center are participating in the trial. In Canada, clinical
sites include the Hospital for Sick Children in Toronto, where Drs.
Eric Bouffet, Sylvain Baruchel, and Ute Bartels lead the international
program, and Alberta's Children's Hospital in Calgary.

    About Nimotuzumab

    Nimotuzumab is a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR). To date nimotuzumab has been administered to
more than 2000 patients and evaluated in more than a dozen clinical trials. It
has been approved in several countries and has been provided on a
compassionate basis in a number of countries including the US, Canada,
Germany, and Australia. The emerging safety data for nimotuzumab suggests a
more benign side-effect profile in its trials with radiation-containing
regimens compared to currently approved EGFR targeting antibodies and small
molecules. To date, in patients treated with nimotuzumab, there has been no
evidence of severe rash or any life-threatening adverse events. The unique
safety profile for nimotuzumab holds the prospect for it to become
best-in-class within this important family of EGFR-targeting agents.
    Nimotuzumab has been designated an Orphan Drug by the US FDA and by the
EMEA for glioma.

    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.

    %SEDAR: 00004652E




For further information:

For further information: Enquiries: Thomas Fechtner, the Trout Group
LLC, Tel. (646) 378-2931, Email: tfechtner@troutgroup.com; James Smith, the
Equicom Group Inc., Tel. (416) 815-0700 x 229, Email: jsmith@equicomgroup.com;
Nominated Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050
6500


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