MISSISSAUGA, ON, Aug. 15 /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
Oncoscience AG (Wedel, Germany), its European partner for the development of
the humanized EGFR-targeting monoclonal antibody, nimotuzumab, has recruited
the 40th and final patient in its international phase III trial combining
nimotuzumab with radiation for the treatment of children and adolescents
suffering from diffuse intrinsic pontine glioma (DIPG). DIPG is an inoperable
form of brain cancer for which treatment options are severely limited. The
Phase III trial is being conducted by an international group of paediatric
oncologists under the lead of principal investigator Professor Udo Bode at the
University of Bonn, Germany. The primary end-point of the trial is
progression-free survival with overall survival as a secondary endpoint.
Nimotuzumab has been designated an Orphan Drug by the EMEA.
"Oncoscience AG is moving to complete this DIPG trial, one in a series
that, if successful, will be an important component of our nimotuzumab
regulatory strategy," said David Allan, Chairman and CEO of YM BioSciences.
"YM has received clearance for a Canadian Phase II trial in children with
recurrent DIPG for which the principal investigatory site is the Hospital for
Sick Children in Toronto, an internationally recognized Centre of Excellence
in paediatric medicine."
Positive European data from a completed second line 47-patient Phase II
nimotuzumab monotherapy trial in recurrent pediatric glioma were most recently
summarized in an oral presentation at ASCO 2007. The clinical benefit rate of
38% after 8 weeks, including partial responses and stable disease, for
patients with recurrent DIPG in this study represents a unique observation in
these end-stage patients and has generated considerable interest.
More than half of the high-grade brain cancers or gliomas over-express
epidermal growth factor receptor (EGFR) and for the most advanced brain
cancers, glioblastoma multiforme (GBM), the level of expression is even
higher. A study involving 29 adults with newly diagnosed high-grade gliomas,
including both anaplastic astrocytomas (AA) and GBM, who were treated with
surgery, external beam radiotherapy and nimotuzumab showed that the treatment
was well tolerated, the median survival time was 17.5 months for the GBM
patients, and has not yet been reached for the AA patients.
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR). To date nimotuzumab has been administered to
approximately 900 patients in more than a dozen clinical trials and on a
compassionate basis. It has been approved in several countries and is being
provided on a compassionate basis in certain countries including Canada,
Germany, Australia and Japan. The drug continues to demonstrate a
significantly more benign side-effect profile compared to all the other
EGFR-targeting antibodies and small molecules targeting the EGF tyrosine
kinase signalling pathway. The absence of any cases of severe rash to date and
the very 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, Argentina and
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(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.
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