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YMB YM Bio.'b'ser1

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Share Name Share Symbol Market Type Share ISIN Share Description
YM Bio.'b'ser1 LSE:YMB London Ordinary Share CA9842382041 CLASS B PFD SHS SER 1 NPV
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.00 -
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Statement re

05/01/2009 12:00pm

UK Regulatory


    YM BIOSCIENCES' NIMOTUZUMAB SELECTED FOR MULTINATIONAL PHASE III TRIAL BY
NATIONAL CANCER CENTRE OF SINGAPORE

    Singapore investigators to coordinate 700 patient trial of EGFR targeting
    antibody for treatment of head and neck cancer

    MISSISSAUGA, ON, Jan. 5 /CNW/ - YM BioSciences Inc. (NYSE Alternext
US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today announced
that the National Cancer Centre of Singapore (NCCS) has selected nimotuzumab,
YM's EGFR-targeting drug, for evaluation in a multinational Phase III trial of
more than 700 patients with cancers of the head and neck. The NCCS stated that
it selected nimotuzumab because of its reported preferential safety profile
compared with other EGFR-targeting cancer drugs. The trial is sponsored by the
NCCS in collaboration with Innogene Kalbiotech Pte. Ltd, ("IGK") YM's licensee
for nimotuzumab for the region.
    "The efficacy of nimotuzumab as an epidermal growth factor receptor
targeted therapy is likely to be comparable to drugs of the same class.
However, what is likely to set nimotuzumab apart is its low toxicity and
favourable safety profile," said Dr. Rikrik Ilyas, Director of IGK. "Patients
are spared the discomfort of severe skin rashes and may benefit from an
enhanced quality of life. Both patients and physicians may also benefit from
lack of hypomagnesemia often related to treatment with other anti-EGFR
targeted drugs. IGK is pleased to support the NCCS in this
investigator-initiated trial of nimotuzumab."
    The NCCS is the lead cancer centre coordinating this clinical trial,
which will involve approximately 22 institutions from 12 countries worldwide.
The trial will treat patients with locally advanced squamous cell cancers of
the head and neck immediately following surgery - the "adjuvant setting".
Along with standard chemotherapy and radiotherapy, half of the patients will
be administered nimotuzumab weekly for an eight week period. The primary
endpoint for this study is two-year and five-year disease-free survival; the
secondary endpoint is two-year and five-year overall survival.
    "This trial further expands the number of late-stage trials investigating
nimotuzumab across a wide range of cancer indications. The decision by the
prestigious NCCS to further investigate nimotuzumab in this large trial
reflects the growing recognition for our drug as potentially the only EGFR
targeting therapy that may provide efficacy without the severe dose-limiting
toxicities of the other drugs in its class. Importantly, this trial includes
the treatment regimen that we have demonstrated as important for nimotuzumab's
preferential binding that should result in equivalent therapeutic benefit to
the currently market drugs while avoiding adverse interactions with normal
tissue," said David Allan, Chairman and CEO of YM BioSciences. "IGK's progress
has been exceptional, having already secured marketing approval in the
Philippines and Indonesia for pediatric and adult recurrent glioma. In
addition to this adjuvant Phase III study a Phase II investigator-initiated
study in locally-advanced head and neck cancers is being conducted by the NCCS
in collaboration with IGK."
    The countries involved in the trial include Japan, South Korea, Taiwan,
Thailand, Indonesia, India, Pakistan, Singapore, Saudi Arabia, Israel, South
Africa and Cuba. The trial is expected to expand into Canada and additional
sites may also be added from the Philippines, Australia and the United
Kingdom. The NCCS anticipates reporting initial results from the trial in
approximately five years.

    About National Cancer Centre Singapore

    The National Cancer Centre Singapore is the premier cancer research and
treatment facility in Singapore and in the region. It was established in 1997
and sees more than 60 percent of the public sector medical oncology cases and
about 70 percent of radiation oncology cases. For more information, visit NCCS
website at www.nccs.com.sg.

    About Innogene Kalbiotech

    Innogene Kalbiotech Ltd (IGK) is the licensee of nimotuzumab for
territories that include Singapore, Indonesia, Malaysia, the Philippines and
South Africa. The licensor is CIMYM BioSciences Inc, YM's majority-owned
subsidiary. Established in Singapore in July 2003, IGK develops and
commercializes biopharmaceuticals and medical diagnostics, specializing in
oncology, intensive care and therapeutic and preventive vaccines. It
coordinates clinical trials and research activities, and manages the
application and commercialization of patents worldwide. A wholly owned
subsidiary of Jakarta-listed pharmaceutical company PT Kalbe Farma Tbk., IGK
spearheads the innovation and globalization for Kalbe of research-based
products.

    About YM BioSciences

    YM BioSciences Inc. is a company that identifies, develops and
commercializes differentiated products principally in the area of oncology for
patients worldwide. The Company is developing nimotuzumab, a humanized
monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery
composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in
development targeting multiple tumour types in combination with radiation,
chemoradiation and chemotherapy. The drug, which is approved for marketing in
a number of countries, is significantly differentiated from all other
currently marketed EGFR-targeting agents because of a remarkably benign
side-effect profile. In more than 3,500 patients reported as having been
treated worldwide, to date, no Grade III/IV incidents of rash or radiation
dermatitis have been described and reports of any of the other severe
side-effects that are typical of EGFR-targeting molecules have been rare.
AeroLEF(R) is in development for the treatment of moderate to severe pain,
including cancer pain. The product has completed a randomized trial and is
being prepared for late-stage development internationally.

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



 



END



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