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YM BioSciences Inc. (YMB)

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Thursday 17 September, 2009

YM BioSciences Inc.

YM BIOSCIENCES NIMOTUZUMAB APPROVED FOR MEXICO ...


YM BIOSCIENCES REPORTS NIMOTUZUMAB APPROVED FOR MARKETING IN MEXICO

    YM Enrolls First Patients in Multinational Randomized, Double-Blind Brain
    Metastases Trial
   
    MISSISSAUGA, Sept. 17 /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 reported that nimotuzumab has been approved for
marketing in Mexico. YM BioSciences also announced that it has enrolled the
first two patients in its randomized, double-blind trial evaluating
nimotuzumab in patients with brain metastases from non-small-cell lung cancer
(NSCLC).
    "Mexico is the 21st country to have approved nimotuzumab for marketing
and, while YM's license for major market territories for nimotuzumab does not
include Mexico, this approval reflects the growing recognition throughout much
of the world of the value to patients of our drug and the progress being made
in its commercialization," said David Allan, Chairman and CEO of YM
BioSciences. "As part of YM's registration strategy for nimotuzumab, we were
also pleased to report the opening of this second of two randomized,
double-blind trials that YM is conducting in Canada and which are both now
being expanded internationally."
    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. Nimotuzumab is approved in two of the countries
in YM's territories. The drug has demonstrated efficacy in clinical trials
without producing the numerous and severe toxicities observed with the other
marketed EGFR-targeting drugs. Mexican regulatory authorities have approved
nimotuzumab for the treatment of squamous cell carcinoma of the head and neck
(SCCHN), adult glioma and pediatric glioma. The approval was granted to
Laboratorios PiSA in Guadalajara, Mexico and nimotuzumab will be
commercialized under the name VECTHIX(R).

    First patients enrolled in multinational randomized, double-blind brain
    metastases trial
   
    YM BioSciences recently enrolled and treated the first two patients in
its multinational randomized, double-blind trial evaluating nimotuzumab plus
whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain
metastases from NSCLC. The trial is designed enroll approximately 88 patients
over twelve months followed by a twelve-month follow-up period and will likely
include 12 investigational centers in Canada plus additional centers in other
countries. The patients were enrolled at the L'Hôpital Maisonneuve-Rosemont in
Montreal, Canada.
    Nimotuzumab (200 mg IV infusions) will be administered weekly during
radiotherapy and following radiotherapy until disease progression,
unacceptable toxicity or at the discretion of the physician. Radiotherapy will
consist of 30 Gy, in 10 fractions of 3 Gy/day. Patients will be assessed by
laboratory tests, imaging studies, standardized neurologic examination, and
neurologic symptoms. The primary efficacy endpoint is intracranial disease
progression over six months. The secondary endpoints are overall survival
(OS); time to neurologic progression (TNP) or death with evidence of
neurologic progression; OS rate at six months; time to intracranial disease
progression; and time to overall progression.
    "This randomized, double-blinded, multicentric trial was based on a
randomized pilot open-label trial from which encouraging, preliminary results
were presented at the EORTC-NCI-AACR "Molecular Targets and Cancer
Therapeutics" meeting held on October 21-24, 2008 in Geneva. YM is preparing
to imminently open the first international centers on both this and the
ongoing palliative NSCLC randomized trial. In this trial, as with the others
being conducted by YM, extensive samples are being collected and stored in
anticipation of a comprehensive program of translational analysis," said Dr.
Leonardo Viana Nicacio, YM's Director of Clinical Affairs.
    Nimotuzumab is reported to have been has been administered to more than
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.
Nimotuzumab is also available on a compassionate use basis in the US for
children with pediatric glioma and is designated an Orphan Drug for adult and
pediatric glioma by the FDA as well as the EMEA for Europe.

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