YM BIOSCIENCES REPORTS POSITIVE NIMOTUZUMAB FOUR-YEAR SURVIVAL DATA PRESENTED AT ASTRO 2009

YM BIOSCIENCES REPORTS POSITIVE NIMOTUZUMAB FOUR-YEAR SURVIVAL DATA PRESENTED
AT ASTRO 2009

- Follow-On Results from a Randomized Phase IIb Head & Neck Trial
Demonstrate Efficacy of Nimotuzumab Without Severe, Class-Associated
Toxicities -

MISSISSAUGA, ON, Nov. 2 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE
Amex: YMI; TSX: YM), a life sciences product development company that
identifies and advances a diverse portfolio of promising cancer-related
products at various stages of development, announced that an oral presentation
at the American Society for Therapeutic Radiology and Oncology (ASTRO) 2009
Annual Meeting reported positive 48-month survival data for its EGFR-targeting
antibody, nimotuzumab. The "BEST" trial was a randomized four-arm study
treating patients with inoperable, locoregionally-advanced, stage III/IVa head
and neck cancer with radiation alone, chemoradiation alone, or radiation or
chemoradiation in combination with nimotuzumab. These data were a follow-up to
30-month survival data presented at ASCO 2009 and demonstrate that the benefit
of adding nimotuzumab to radiation and chemoradiation is durable and persists
for several years.
"These data are convincing evidence that nimotuzumab is an efficacious and
safe drug and highlight its potential in the head and neck cancer indication.
In this respect we note that the National Cancer Centre of Singapore has
initiated a global Phase III trial with nimotuzumab in the adjuvant setting
for head and neck cancer patients," said David Allan, Chairman and CEO of YM
BioSciences. "Activity of nimotuzumab in the BEST trial was similar to that
demonstrated in separate trials with cetuximab in locally advanced head and
neck cancer but there was no evidence that nimotuzumab's activity was
accompanied by the advanced toxicities of the class."
In the ASTRO presentation, Dr. Lokesh Viswanth, Kidwani Memorial Institute of
Oncology, Bangalore, India described that the addition of nimotuzumab to
radiotherapy (RT) and chemoradiotherapy (CRT) had an important effect on
overall survival. At 48 months, 41% of the patients in the nimotuzumab+CRT arm
were alive compared to 21% in CRT-alone arm, and 34.7% in the nimotuzumab+RT
arm were alive compared to 13% in the RT-alone arm. The difference at 48
months between CRT and nimotuzumab+CRT arms reached statistical significance
(p=0.0149). Kaplan-Meier curves for survival maintained a consistent
separation at the 48-month update, demonstrating that the benefit of adding a
fixed course of nimotuzumab to RT and CRT persists for an extended period.
Because efficacy results in the control groups in this trial were similar to
those published in contemporaneous international trials in this indication,
and because imbalances between the study arms were minor, authors concluded
that the benefit presented in this proof of principle trial must be
attributable to the activity of nimotuzumab.
The trial contained no reports of late toxicity with nimotuzumab and its
benign side-effect profile continued to be demonstrated. The combination of
nimotuzumab with radiotherapy and chemoradiotherapy was safe and nimotuzumab
did not potentiate radiation dermatitis. As a consequence, continuing reports
concerning cetuximab and its significant potentiation of severe radiation
dermatitis in the treatment of head and neck cancer with radiation continues
to differentiate nimotuzumab which, as first described in a poster at AACR
2009, binds selectivity to cancer tissues thereby avoiding exacerbation of
damage to healthy tissues by radiation.
"This trial adds to the body of clinical data concerning the activity of
nimotuzumab in head and neck cancer, which includes a number of earlier
trials. The presentation at ASTRO 2009 adds an important level of
understanding for nimotuzumab's development highlighting its prospect to be
the best anti-EGFR monoclonal antibody in this patient population," said
Leonardo Viana Nicacio, M.D., Director of Clinical Affairs for YM BioSciences.
"The data are now shown to be reproducible in three separate studies, all of
which reported nimotuzumab's characteristically benign toxicity profile. While
the chemoradiotherapy and radiotherapy protocols in BEST differ from those
commonly used in North America and Europe, treatments were consistent between
the arms allowing for an appropriate assessment of nimotuzumab's activity and
efficacy. These data, which suggest activity and durability similar to other
anti-EGFR antibodies in this population, support the intended initiation of
Phase III trials in this patient population."
A total of 92 patients were enrolled in the BEST trial, of which 76 were
considered evaluable. The trial was sponsored by Biocon Ltd., the licensee
from CIMAB S.A. for nimotuzumab in India. A poster describing 30-month data
from this trial was presented at the 2009 ASCO Annual Meeting and is entitled:
"A Phase IIb 4-arm open-label randomized study to assess the safety and
efficacy of h-R3 monoclonal antibody against EGFR in combination with
chemoradiation therapy or radiation therapy in patients with advanced (Stage
III or IVa) inoperable head and neck cancer", by Reddy BK et al. (Citation: J
Clin Oncol 27:15s, 2009; Abstract No: 6041; Session: Head and Neck Cancer).
The data presented at ASCO demonstrated that the addition of nimotuzumab to
both the radiation and chemoradiation regimens improved the overall response
rate, survival rate at 30 months, median progression-free survival and median
overall survival. An unplanned, retrospective, combined group analysis of the
nimotuzumab arms vs. the non-nimotuzumab arms demonstrated a significant
difference in overall survival (p=0.0018) favoring nimotuzumab. The addition
of nimotuzumab did not add to the severe toxicities of either regimen, with no
Grade 3-4 skin toxicities observed. The authors concluded that the efficacy of
nimotuzumab compares favorably to results reported for cetuximab and that this
efficacy was not accompanied by the latter's severe toxicities. They also
concluded that this trial is the first randomized study in head and neck
cancer to their knowledge that challenges the adopted tenet that the efficacy
of EGFR inhibitors is linked to the toxicity of the class.

About YM BioSciences

YM BioSciences Inc. is a life sciences product development company that
identifies and advances a 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.
Nimotuzumab is a humanized monoclonal antibody in development worldwide,
targeting multiple tumor types primarily in combination with radiation and
chemoradiation. It is significantly differentiated from all other currently
marketed EGFR-targeting agents due to its remarkably benign side-effect
profile. Nimotuzumab's anti-tumor activity has led to its approval for
marketing in 23 countries. In more than 5,000 patients reported as having been
treated with nimotuzumab worldwide to date, no Grade IV incidents of radiation
dermatitis have been described, severe rash has not been observed and reports
of the other severe side-effects that are typical of EGFR-targeting molecules
have been rare. Nimotuzumab is licensed to YM's majority-owned subsidiary,
CIMYM BioSciences Inc., by CIMAB S.A., and was developed at the Center of
Molecular Immunology. YM is developing AeroLEF for the treatment of moderate
to severe acute pain. The product is differentiated from other approaches
using opioids because patients are able to individually control the analgesia
required for their differing intensities of pain. AeroLEF met all endpoints in
a randomized Phase II trial and is currently 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.

SOURCE YM BioSciences Inc.

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