YM BIOSCIENCES USA CLEARED BY US FDA TO INITIATE PHASE II CLINICAL TRIAL OF NIMOTUZUMAB IN CHILDREN WITH INOPERABLE, RECURRENT BRAIN CANCER



    MISSISSAUGA, ON, Aug. 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 its
wholly-owned US subsidiary, YM BioSciences USA Inc. ("YM-USA") has been
cleared by the US Food and Drug Administration (FDA) to initiate a Phase II
trial investigating nimotuzumab in pediatric patients with recurrent diffuse
intrinsic pontine glioma (DIPG), a form of inoperable, treatment-resistant
brain cancer. Nimotuzumab is a humanized monoclonal antibody that targets the
epidermal growth factor receptor (EGFR). Eight leading US pediatric clinical
centers will be participating in the study. YM BioSciences previously
announced that it had received a No Objection Letter from Health Canada in
June 2007 to initiate this single-arm trial, which will enrol 44 patients with
DIPG who will be treated with nimotuzumab as monotherapy.
    This is the first occasion, to the knowledge of the Company, in which a
clinical trial has been cleared by the FDA for a drug of Cuban origin.
Clearance for importation of nimotuzumab into the US for this trial was
authorized by a Special License issued to YM-USA by the US Treasury
Department's Office of Foreign Assets Control (OFAC). Nimotuzumab has already
been administered to a number of children in the US under licenses from the US
Treasury Department and under single-patient INDs from the FDA.
    "The clearance of this US IND by the FDA is a significant step in the
development of nimotuzumab," said David Allan, Chairman and CEO of YM
BioSciences. "In addition to the US investigatory sites, the global
development program for nimotuzumab includes ongoing and planned clinical
trials involving this and various other indications of cancer in Canada,
Europe, Japan, Korea, Singapore, India, Argentina, and Brazil."
    The trial design is based on a previous trial conducted in Germany. In
that trial, which was the subject for an oral presentation at ASCO 2007, eight
of 21 children with recurrent DIPG had a clinical benefit from treatment with
nimotuzumab as monotherapy - one Partial Response (PR) and seven Stable
Disease (SD) were reported in 21 patients, at the end of the induction phase
at the eighth week. Those eight patients continued on maintenance therapy and,
at week 21, three patients were declared PR and one was evaluated SD. No
reports of OR in this patient population has, to the knowledge of the Company,
been previously reported.
    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 from initiation. The principal investigatory site is the Hospital
for Sick Children in Toronto, Canada where Drs. Eric Bouffet, Sylvain
Baruchel, and Ute Bartels lead the international program. The US investigatory
sites at which the trial will be conducted include leading pediatric
neuro-oncology centers that are members of the "POETIC" consortium (Pediatric
Oncology Experimental Therapeutics International Consortium). Members of
POETIC include 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, Children's Healthcare of Atlanta
at Egleston, the Children's Hospital at the University of Colorado and the
University of Florida and Alberta's Children's Hospital in Calgary. In
addition, the University of Rochester Medical Center and the New York
University Medical Center will also be included in the trial.
    YM BioSciences' European partner for the development of nimotuzumab,
Oncoscience AG, recently announced the enrolment of the 40th and final patient
in its international Phase III trial combining nimotuzumab with radiation for
the first-line treatment of children and adolescents with newly diagnosed
DIPG.

    Nimotuzumab

    Nimotuzumab is a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR). To date nimotuzumab has been administered to
over 900 patients in more than a dozen clinical trials and on a compassionate
basis. It has been approved in several countries and has been provided on a
compassionate basis in certain countries including the US, Canada, Germany,
and Australia. The emerging safety data for nimotuzumab suggests a more benign
side-effect profile compared to currently approved EGFR targeting antibodies
and small molecules. The absence of any cases of severe rash to date and the
rare instances of any of the other debilitating side effects holds the
prospect for nimotuzumab to become best-in-class for this important family of
EGFR-targeting agents.

    Nimotuzumab global development programs

    Nimotuzumab is licensed to YM's majority-owned Canadian subsidiary, CIMYM
BioSciences Inc., by CIMAB, S.A., the corporation representing the Centre for
Molecular Immunology, which was responsible for the discovery and early
development of this unique molecule. Nimotuzumab has been sub-licensed by
CIMYM to Daiichi Sankyo Co., Ltd for Japan, Oncoscience AG in Europe, Kuhnil
Pharmaceutical Co. in South Korea and Innogene Kalbiotech in Southeast Asia.
    In the territories for which YM has licensed nimotuzumab the drug is
currently in varying stages of development in colorectal cancer, adult and
pediatric glioma, non-small-cell lung cancer and pancreatic cancer and YM
expects that the range of indications will continue to broaden in 2008 as the
group's cooperative efforts expands.
    In countries outside of YM's territories, nimotuzumab is in development
by seven licensees and is already approved for treatment of cancers of the
head and neck in a number of those including India, China, Cuba, Columbia and
Argentina.
    YM anticipates that the licensees will increasingly participate
cooperatively to accelerate the rate of recruitment into trials of common
interest, thereby reducing the costs of development for each participant, and
shortening the time to completion of trials.

    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-, 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- 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:

For further information: Enquiries: Thomas Fechtner, the Trout Group
LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028, Email:
tfechtner@troutgroup.com; James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Fax (416) 815-0080, Email: jsmith@equicomgroup.com; Nominated
Advisor, Canaccord Adams Ltd., Ryan Gaffney, Tel. +44(0)20 7050 6500


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