Oncothyreon Announces that L-BLP25 (Stimuvax®) Did Not Meet Primary Endpoint of Improvement in Overall Survival in Pivotal

 Oncothyreon Announces that L-BLP25 (Stimuvax®) Did Not Meet Primary Endpoint
 of Improvement in Overall Survival in Pivotal Phase 3 Trial in Patients with
                          Non-Small Cell Lung Cancer

PR Newswire

SEATTLE, WA, Dec. 19, 2012

Company to Hold Conference Call at 8:30 am EST Today

SEATTLE, WA, Dec. 19, 2012 /PRNewswire/ - Oncothyreon Inc. (Nasdaq: ONTY)
today announced that the pivotal Phase 3 clinical trial of L-BLP25 (formerly
referred to as Stimuvax^®) known as START did not meet its primary endpoint of
an improvement in overall survival in patients with unresectable, locally
advanced stage IIIA or stage IIIB non-small cell lung cancer (NSCLC). The
trial was conducted by Merck Serono, a division of Merck KGaA of Darmstadt,
Germany, under a license agreement with Oncothyreon.

Despite not meeting the primary endpoint, notable treatment effects were  seen 
for L-BLP25 in certain subgroups. Further  analyses are planned in the  coming 
weeks to  explore the  potential benefit-risk  profile of  L-BLP25 in  certain 
populations. Merck Serono will  discuss these data  with external experts  and 
regulatory authorities over the coming months. More detailed results from the
START trial will be submitted for  publication in a peer reviewed journal  and 
presentation at upcoming scientific meetings.

"We believe that the START study  will offer important scientific insights  to 
the potential for immunotherapies in the treatment of this devastating disease
and we intend to discuss these  data with scientific community and  regulatory 
authorities to gain their advice on  potential next steps," said Dr.  Annalisa 
Jenkins, Head of  Global Drug Development  and Medical for  Merck Serono.  The 
ongoing clinical program of L-BLP25 that includes studies in the Asia  Pacific 
region will continue pending discussion with relevant regulatory agencies.

START was a  randomized, multicenter,  double-blind, placebo-controlled  trial 
that assessed the  efficacy, safety  and tolerability of  L-BLP25 in  patients 
with unresectable stage III  NSCLC who achieved a  response or stable  disease 
after chemoradiotherapy. Patients were randomized  to receive either a  single 
low dose of cyclophosphamide followed by L-BLP25 (weekly injections for  eight 
weeks followed  by injections  every six-weeks  until progression)  plus  best 
supportive care (BSC) or  placebo plus BSC. More  than 1,500 patients from  33 
countries were recruited into the START trial.

Patient safety in the START trial  was monitored frequently by an  independent 
data monitoring committee and no new or unexpected safety concerns were  noted 
for the study. In prior clinical studies, the most frequently reported adverse
events included injection  site reactions, flu-like  symptoms, nausea,  cough, 
fatigue, and dyspnea.

"These results from the START trial are disappointing, both for patients  with 
NSCLC and for the many  who have been involved  in the L-BLP25 program,"  said 
Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "L-BLP25 has  been 
under development for more  than a decade at  Oncothyreon and its  predecessor 
company, Biomira Inc. of Edmonton, Alberta, in collaboration with Merck KGaA.
The contributions of many employees  at each company, committed  investigators 
and, particularly, the  many patients  who participated  in multiple  clinical 
trials over many years are gratefully acknowledged."

Conference Call and Webcast

Oncothyreon will conduct a  conference call today, December  19, 2012 at  8:30 
a.m. Eastern time (5:30 a.m. Pacific time) to discuss the outcome of the START
trial and provide  a review of  its pipeline of  products in development.  To 
participate in  the call  by  telephone, please  dial (877)  280-7291  (United 
States) or  (707) 287-9361  (International). In  addition, the  call will  be 
webcast live and can be accessed on  the "Events" page of the "News &  Events" 
section of Oncothyreon's  website at www.oncothyreon.com.  An archive of  the 
webcast will  be available  after completion  of the  discussion and  will  be 
posted on Oncothyreon's website.

About L-BLP25

L-BLP25 is an investigational MUC1 antigen-specific cancer immunotherapy  that 
is designed to stimulate the body's immune system to identify and target cells
expressing the  cell surface  glycoprotein  MUC1. MUC1  is expressed  in  many 
cancers, such as non-small cell lung cancer (NSCLC), and has multiple roles in
promoting tumor growth  and survival.  L-BLP25 was being  investigated in  the 
Phase III  START trial  and is  currently being  investigated in  the  INSPIRE 
trial, both for the treatment of unresectable stage III NSCLC.

Merck  obtained   the  exclusive   worldwide   rights  for   development   and 
commercialization of L-BLP25 from Oncothyreon Inc., Seattle, Washington,  USA, 
in 2007, in an agreement  replacing prior collaboration and supply  agreements 
originally entered in 2001. In Japan, Merck entered into a co-development  and 
co-marketing agreement for L-BLP25 with  Ono Pharmaceutical Co., Ltd.,  Osaka, 
Japan.

The START  study  was a  Phase  III, multi-center,  randomized,  double-blind, 
placebo-controlled clinical trial  designed to evaluate  the efficacy,  safety 
and tolerability of  L-BLP25 in  patients suffering  from unresectable,  stage 
IIIA or IIIB NSCLC who  have had a response or  stable disease after at  least 
two cycles of platinum-based chemoradiotherapy.  The study involves more  than 
1,500 patients in  33 countries. The  primary endpoint of  the START study  is 
overall survival.

The INSPIRE  study is  a Phase  III, multi-center,  randomized,  double-blind, 
placebo-controlled clinical trial  designed to evaluate  the efficacy,  safety 
and tolerability  of L-BLP25  in  patients of  Asian heritage  suffering  from 
unresectable, stage  IIIA or  IIIB NSCLC  who have  had a  response or  stable 
disease after at  least two  cycles of  platinum-based chemoradiotherapy.  The 
design of the INSPIRE  study is almost identical  to the START study.  INSPIRE 
will enroll approximately  420 unresectable, stage  III NSCLC patients  across 
China, Hong Kong, Korea, Singapore and Taiwan.

About Oncothyreon

Oncothyreon is  a biotechnology  company specializing  in the  development  of 
innovative therapeutic  products for  the treatment  of cancer.  Oncothyreon's 
goal is to  develop and  commercialize novel synthetic  vaccines and  targeted 
small molecules that have the potential  to improve the lives and outcomes  of 
cancer patients. For more information, visit www.oncothyreon.com.

Forward Looking Statements

In order  to provide  Oncothyreon's  investors with  an understanding  of  its 
current intentions and future prospects, this release contains statements that
are forward looking, including statements related to analysis and  development 
of additional  insights from  clinical trial  results, as  well as  statements 
related to  the  timing,  duration  and  results  of  clinical  trials.  These 
forward-looking  statements   represent   Oncothyreon's   intentions,   plans, 
expectations and  beliefs and  are based  on its  management's experience  and 
assessment of  historical  and  future  trends  and  the  application  of  key 
assumptions relating to future events and circumstances.

Forward-looking statements involve  risks and  uncertainties, including  risks 
and  uncertainties  related  to  potential  insights  from  the  START  study, 
potential treatment effects of L-BLP25, the safety and efficacy of our product
candidates and the timing, duration and results of clinical trials, as well as
risks and  uncertainties related  to Oncothyreon's  business and  the  general 
economic environment.  Many  of  these  risks  and  uncertainties  are  beyond 
Oncothyreon's control.  These risks,  uncertainties  and other  factors  could 
cause our  actual  results  to  differ  materially  from  those  projected  in 
forward-looking statements.  There can  be no  guarantee that  the results  of 
preclinical studies or clinical trials will be predictive of either safety  or 
efficacy in future clinical  trials. These and  other risks and  uncertainties 
are described in  the reports and  other documents filed  by Oncothyreon  Inc. 
with the SEC and/or Canadian regulatory authorities.

Although Oncothyreon believes  that any  forward-looking statements  contained 
herein are reasonable,  it can  give no  assurance that  its expectations  are 
correct. All  forward-looking  statements  are expressly  qualified  in  their 
entirety by this cautionary statement. For a detailed description of the risks
and uncertainties associated  with Oncothyreon, you  are encouraged to  review 
the official corporate documents filed  with the securities regulators in  the 
United States on U.S. EDGAR  and in Canada on  SEDAR. Oncothyreon is under  no 
obligation to (and expressly disclaims any such obligation to) update or alter
its forward-looking statements whether as a result of new information,  future 
events, or otherwise.

SOURCE Oncothyreon Inc.

Contact:

Investor and Media Relations Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@oncothyreon.com
 
Press spacebar to pause and continue. Press esc to stop.