YM BIOSCIENCES ANNOUNCES NIMOTUZUMAB PRESENTATIONS

 
TIDMYMB 
 
YM BIOSCIENCES ANNOUNCES NIMOTUZUMAB PRESENTATIONS TO BE MADE AT THE 100TH 
ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH AND EUROPEAN 
SOCIETY FOR MEDICAL ONCOLOGY 
 
    MISSISSAUGA, ON, March 13 /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 reported 
that its poster entitled, "Binding properties of the anti-EGFR monoclonal 
antibody, nimotuzumab, limit interaction with the EGFR in renal and epidermal 
cells", has been accepted for presentation at the American Association for 
Cancer Research's (AACR) 100th Annual Meeting in Denver, Colorado on April 
20th, 2009 (Abstract No. 2763; Hall B-F, Poster Section 31; Session ID: 
Clinical Research 10). 
    The abstract of this poster has been published today (09-AB-5492-AACR). 
    "Data to be presented at the AACR and ESMO conferences, combined with 
rash being reported independent of the KRAS status of patients, are in sharp 
contrast to the dated speculation that toxicity is a marker for efficacy of 
EGFR-targeting agents," said David Allan, Chairman and CEO of YM BioSciences. 
"The data we present show the monovalent binding to normal cells of other 
antibodies confirming that only nimotuzumab will avoid severe rash, 
hypomagnesemia and the other debilitating toxicities common with the marketed 
antibodies. Consequently, nimotuzumab's benign safety profile makes it the 
anti-EGFR agent of choice for chronic use." 
    The objectives of the study to be presented at AACR were to examine 
whether the cause of the toxicities seen with currently marketed anti-EGFR 
antibodies, particularly severe skin rash and hypomagnesemia, were the result 
of properties intrinsic to the individual antibodies or to the class. The 
results show that Erbitux(R) binds to normal cells because it is capable of 
monovalent binding to very low expressions of EGFR whereas nimotuzumab's 
monovalent binding is transient. It is this transient monovalent binding that 
results in its benign safety profile. Both antibodies bind definitively when 
binding bivalently. 
    The poster presentation will also include data describing the similar 
anti-tumor effects of nimotuzumab and cetuximab against EGFR-overexpressing 
tumors. Nimotuzumab's requirement for bivalent binding (similar to conditions 
that make Herceptin(R) effective), limits the accumulation of nimotuzumab to 
tissues with higher EGFR density (principally occuring in tumors). 
    "This research, together with the accumulating clinical data on 
nimotuzumab, demonstrate that, where tumors over-express EGFR naturally, or 
are stimulated to over-express EGFR by radiation-containing regimens, 
nimotuzumab would be expected to have similar efficacy to Erbitux(R) and 
Vectibix(R)," explained David Allan. 
    The authors conclude that toxicities of Erbitux(R) should not be viewed 
as markers for clinical benefit of EGFR-targeting antibodies in general, but 
only as markers of indiscriminate targeting of that particular antibody, with 
the EGFR blockade of normal cells by the marketed antibodies disrupting the 
cell's function. This finding is especially important in view of the recent 
papers describing the underreporting of the toxicities of Erbitux(R), 
particularly Grade IV radiation dermatitis in head and neck cancer, reportedly 
not previously observed with radiation alone. These presentations by YM help 
to demonstrate the nature of differentiation of nimotuzumab from the other 
anti-EGFR antibodies and show that its intrinsic properties confer a wide 
therapeutic window compared to Erbitux(R) and thus, in contrast to it, 
nimotuzumab is a more precisely targeted therapy. 
    The AACR abstract builds on a presentation by YM at the AACR 
Translational Medicine conference held in June 2008, which demonstrated that, 
in tumor cells expressing moderate-to-high levels of the EGF receptor, 
nimotuzumab has binding equivalent to the currently marketed EGFR-targeting 
antibodies. The AACR 2009 presentation includes data demonstrating equivalent 
anti-tumor effects of nimotuzumab and cetuximab against EGFR-overexpressing 
tumors. 
 
    European Society for Medical Oncology (ESMO) Presentation, March 23-25, 
    2009 
 
    Additionally, YM announced that a further poster entitled "Differences in 
clinical safety profiles of nimotuzumab and cetuximab, EGFR-targeting 
antibodies, as a consequence of divergent monovalent/bivalent binding profiles 
of these agents" has been accepted for presentation at the European Society 
for Medical Oncology's 7th International Symposium on Targeted Anticancer 
Therapies 2009 in Amsterdam, Netherlands being held March 23rd - 25th, 2009 
(Abstract code C02). 
    "The three posters referenced are a partial reflection of the current, 
extensive activity at YM, its licensees and at other nimotuzumab developers 
worldwide aimed at explaining the benign toxicity profile of nimotuzumab given 
its established anti-tumour activity," said David Allan. "We believe that 
these compelling results, combined with the evidence of efficacy of 
nimotuzumab in the correct settings, and with the appropriate regimens, should 
convince investors that the market is inappropriately discounting the value of 
the nimotuzumab clinical program." 
    YM is conducting two international, multi-center, randomized, 
double-blinded Phase II trials with nimotuzumab in combination with radiation. 
These two indications - brain metastasis from lung cancer and palliative 
therapy in non-small cell lung cancer (NSCLC) - represent indications of high 
unmet need. In the US, approximately 140,000 cases of brain metastasis are 
diagnosed annually and the frequency is increasing as more patients live 
longer. The incidence of lung cancer in the US is approximately 215,000 cases 
of which 80-85% is NSCLC. Recruitment of these trials is expected to be 
complete in 2010. 
 
    Notice for AIM Compliance 
 
    The Company was notified on 27 February 2009 that on 17 February 2009, 
Mr. Gabe Hoffman directly and through Accipiter Capital Management, LLC and 
associated companies decreased holdings in the Company to 2,814,932 common 
shares, representing 4.8 per cent voting rights attached to the issued common 
share capital of the Company, being 58,216,309 common shares. This information 
is being provided in order to comply with the rules for AIM listed companies. 
 
    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 over 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: Enquiries: James Smith, the Equicom Group Inc., Tel. 
[phone] x 229, Email: [e-mail]; Thomas Fechtner, the 
Trout Group LLC, Tel. [phone], Email: [e-mail]; 
Nominated Adviser: Canaccord Adams Limited, Ryan Gaffney, Tel. [phone] 
6500 
(YMBA) 
 
 
 
 
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