NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD & NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS



    
    - Results from a randomized Phase IIb trial reported at 2009 ASCO Annual
    Meeting -
    

    MISSISSAUGA, ON, June 1 /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 results from a randomized
trial of nimotuzumab (aka BIOMAb/TheraCIM/h-R3) in patients with inoperable,
locoregionally advanced Stage III/IVa head and neck cancer conducted by Reddy
BK et al (Kidwai Memorial Institute of Oncology, Bangalore, India), were
presented in a poster at the 2009 ASCO Annual Meeting. The trial demonstrates
that the efficacy of nimotuzumab compares favorably to results reported for
cetuximab, an EGFR-targeting antibody marketed as Erbitux(R), but that this
efficacy was not accompanied by the severe toxicities reported in patients
treated with cetuximab. The authors further conclude 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.
    "These data are further evidence of the unsupported extrapolation to the
class of the toxicity/benefit correlation in the marketed EGFR drugs. The
trial data demonstrate that patients have the prospect of equivalent clinical
benefit from nimotuzumab as from the rest of the class without the physical,
emotional and financial costs that result from the numerous and severe
toxicities of Erbitux(R) which are a consequence of the demonstrable inability
of that drug to discriminate between healthy cells and tumor cells," said
David Allan, Chairman and CEO of YM BioSciences. "We expect that, as the
numerous randomized trials currently ongoing worldwide with nimotuzumab
report, the evidence for this claim will become increasingly robust."
    Reddy BK et al. conducted a randomized Phase IIb, four-arm, open-label
study designed to assess the safety and efficacy of nimotuzumab in combination
with radiation therapy (RT) or chemoradiation therapy (CRT) in patients with
inoperable (Stage III or IVa) squamous cell carcinoma of the head and neck
(SCCHN). Stage III-IV SCCHN patients are reported to account for 50-60% of
head and neck cancer patients. A total of 92 patients were enrolled of which
76 were considered evaluable. 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. A 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 results of the study are presented in the table below.

    
    Summary of Efficacy Parameters - Reddy BK et al study:
    -------------------------------------------------------------------------
    PARAMETER                             GROUP A            GROUP B
                                      ---------------------------------------
                                                  RT+               CRT+
                                        RT   nimotuzumab   CRT   nimotuzumab
    -------------------------------------------------------------------------
    Overall Response Rate
     (ORR = CR + PR) (%)      37       76         70       100
    -------------------------------------------------------------------------
    Survival Rates at 30 Months (%)   21.70    39.10      21.70     69.50(*)
    -------------------------------------------------------------------------
    Median Progression Free
     Survival (Months)                 6.90    20.71      21.30        NR
    -------------------------------------------------------------------------
    Median Overall Survival at
     30 months (Months)               15.07       NR         25        NR
    -------------------------------------------------------------------------
    (*) Statistically significant; NR = Not reached at 30 months
    

    The response rates observed by the authors compare favorably with
previous studies of cetuximab in combination with RT alone or CRT. Bonner JA
et al (N. Engl J Med. 2006 Feb 9;354(6); 567-78) published on a randomized
Phase III study with 424 patients comparing radiotherapy alone to radiotherapy
plus cetuximab in locally-advanced squamous cell carcinoma of the head and
neck, reporting a 74% ORR in the cetuximab plus radiotherapy arm.
"Notwithstanding limitations in inter-study comparisons, the comparative data
are reassuring," noted Dr. Leonardo Viana Nicacio, M.D., Director, Clinical
Affairs for YM BioSciences.
    Pfister DG et al (J Clin Oncol. 2006 Mar 1;24(7): 1072-8) presented the
first study combining cetuximab with chemoradiotherapy. That 22 patient pilot
Phase II study combined cetuximab with a chemoradiotherapy regimen (cisplatin
100mg/m2 d1, 22) in Stage III or IV, M0, squamous cell carcinoma patients. The
population in that study was similar to the Reddy BK et al study although the
chemotherapy dose intensity had slight differences in favor of the Pfister DG
et al study (Table 2). The ORR in both studies were similar: 94% for cetuximab
+ CRT and 100% for nimotuzumab + CRT. Although the Pfister DG et al study had
a longer follow-up, overall survival curves at 30 months are similar to the
data in the Reddy BK et al study. The major difference between the studies is
the benign toxicity profile reported with nimotuzumab. No deaths in the
nimotuzumab trial were attributable to the treatment and no additional serious
adverse events were noted.

    
    Comparison of Efficacy Parameters - Reddy BK et al study vs. Pfister DG
    et al study
    -------------------------------------------------------------------------
    PARAMETER                            Nimotuzumab + CRT   Cetuximab + CRT
    -------------------------------------------------------------------------
    Number of patients                             20                22
    -------------------------------------------------------------------------
    Male (%)                                       87                91
    -------------------------------------------------------------------------
    Median KPS                                     80                90
    -------------------------------------------------------------------------
    Disease site (%)
    -------------------------------------------------------------------------
      Oral cavity                                  22                14
    -------------------------------------------------------------------------
      Oropharynx                                   43                59
    -------------------------------------------------------------------------
      Hypopharynx                                  22                 5
    -------------------------------------------------------------------------
      Other                                        13                22
    -------------------------------------------------------------------------
    Stage (%)
    -------------------------------------------------------------------------
      III                                          13                14
    -------------------------------------------------------------------------
      IV                                           87                86
    -------------------------------------------------------------------------
    

    The Reddy BK et al study was a randomized study with two control arms.
This design was employed to facilitate comparison with other studies despite
potential differences in treatment between India and Western countries.
Notwithstanding the limited size of the study the survival rate at 30 months
for the CRT + nimotuzumab arm was statistically superior to CRT arm, and
compares favorably with historical controls performed in Western countries
(Brizel DM, Albers ME, Fisher SR, et al: Hyperfractionated irradiation with or
without concurrent chemotherapy for locally advanced head and neck cancer. N
Engl J Med 338:1798-1804, 1998); (Adelstein DJ, Li Y, Adams GL, et al: An
intergroup Phase III comparison of standard radiation therapy and two
schedules of concurrent chemoradiotherapy in patients with unresectable
squamous cell head and neck cancer. J Clin Oncol 21:92-98, 2003); (Calais G,
Alfonsi M, Bardet E, et al: Randomized trial of radiation therapy versus
concomitant chemotherapy and radiation therapy for advanced stage oropharynx
carcinoma. J Natl Cancer Inst 91:2081-2086, 1999).
    "The data from the Reddy BK et al proof-of-concept study clinically
support the mechanistic attributes of nimotuzumab recently made public for the
first time (Tikhomirov et al, AACR Meeting Abstract (2008) 2008: A36), that
account for nimotuzumab having the prospect for the widest therapeutic window
in its class. Nimotuzumab's unique density-selectivity causes it to target the
higher density of EGFR found in tumor cells while avoiding the lower density
of EGFR in the cells of skin, kidney and gut. In the clinical setting, where
the tumor cells rely on the EGFR pathway to repair cytotoxic damage,
nimotuzumab reproduces the efficacy of the other EGFR inhibitors in the
presence of an astonishingly benign safety profile. The toxicity/benefit
correlation remains generally true for the marketed drugs in this class,
however our findings demonstrate that the extension of this correlation to the
entire class is unsubstantiated," added Dr. Nicacio.
    The poster presented at the 2009 ASCO Annual Meeting 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; Type: General
Poster Session; Time: Monday June 1, 8:00 AM to 12:00 PM; Location: Level 2,
West Hall C). The trial was sponsored by Biocon Ltd., the licensee from CIMAB
S.A. for nimotuzumab in India.

    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.
    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 more than 12 countries. In more than 3,500 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 fentanyl because patients can 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.





For further information:

For further information: Enquiries: 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


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