YM BIOSCIENCES USA RECEIVES CLEARANCE FROM US TREASURY DEPARTMENT TO EXTEND CLINICAL PROGRAM FOR NIMOTUZUMAB



    MISSISSAUGA, ON, Aug. 10 /CNW/ - YM BioSciences Inc. (NYSE Amex:  YMI,
TSX:YM, AIM:YMBA), a life sciences product development company that identifies
and advances a diverse portfolio of promising cancer-related products at
various stages of development, today announced that its wholly-owned
subsidiary, YM BioSciences USA Inc. (YM-USA) has received a license from the
US Department of the Treasury's Office of Foreign Assets Control (OFAC) to
further develop its lead product, nimotuzumab, for patients with solid tumor
cancers in the United States.
    "This license from OFAC to develop nimotuzumab in any cancer indication
is a major step forward in our US development program and will allow us to
immediately discuss our IND submissions with the FDA to include US patients in
our randomized, double-blinded lung cancer and brain metastases trials," said
David Allan, Chairman and CEO of YM BioSciences. "Our development plans may
also include extending some of the Phase III trials being conducted worldwide
into the US. There are quantifiable physical, emotional and financial costs
that result from the numerous and severe toxicities of the currently available
EGFR-targeting drugs which are not evident with the administration of our
drug. Nimotuzumab has been demonstrating efficacy in trials throughout the
world and we are very pleased that US patients will now have the opportunity
to receive the drug and that a broader group of US oncologists will gain
experience with it. Our goal is to bring this therapeutic option, already
approved for marketing in 18 countries, to patients in the US as rapidly as
possible."
    Mr. Allan added, "We have also applied to OFAC for a license to make
nimotuzumab available to US patients upon marketing approval by the FDA. This
is consistent with a 2009 Staff Report to the US Senate Committee on Foreign
Relations (SCFR) entitled 'Changing Cuba Policy - In the United States'
National Interest,' which recommended pharmaceutical imports from Cuba's
rapidly developing biotech industry. We are most appreciative of the extensive
support we have received for our application from SCFR Chairman Senator John
Kerry (D-MA), Western Hemisphere Subcommittee Chairman Senator Chris Dodd
(D-CT) and SCFR Ranking Member Senator Richard Lugar (R-IN) and for their
acute understanding of the needs of cancer patients. Such licenses have been
previously granted to two companies seeking to commercialize Cuban-origin
therapeutics in the US and we have ongoing discussions with OFAC in this
regard."
    YM USA previously received a license from OFAC to import nimotuzumab into
the US to conduct a study of nimotuzumab in children suffering from recurrent
diffuse intrinsic pontine glioma. This trial is ongoing at 10 of the principal
oncology hospitals in the US and data is expected in 2010. Nimotuzumab is also
available on a compassionate use basis in the US for children with this
condition and is designated an Orphan Drug for adult and pediatric glioma by
the FDA as well as the EMEA for Europe.
    Nimotuzumab is a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary,
CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of
Molecular Immunology in Cuba. The drug has demonstrated efficacy in clinical
trials without the serious side effects observed with the marketed
EGFR-targeting drugs. Nimotuzumab has been administered to approximately 5,000
patients worldwide and is currently in 32 trials internationally of which 11
are being conducted by YM and its four licensees. Three of the latter are
Phase III trials, including one being conducted by the internationally
recognized National Cancer Center of Singapore, which selected nimotuzumab
over the alternative antibodies because of its benign side effect profile.

    About YM BioSciences

    YM BioSciences Inc. is a life sciences product development company that
identifies and advances a diverse portfolio of promising cancer-related
products at various stages of development. The Company is currently developing
two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized
Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of
free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical
trial expertise and a diversified business model designed to reduce risk while
advancing clinical products toward international approval, marketing and
commercialization.

    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:

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


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890