SEATTLE, Aug. 3 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY) (the
"Company") today announced that clinical data relating to long-term treatment
with Stimuvax were presented at the International Association for the Study of
Lung Cancer's 13th World Conference on Lung Cancer in San Francisco on August
1, 2009. The presentation by Dr. Glenwood Goss from the Ottawa Hospital Cancer
Centre, Ottawa, Ontario, involved 16 patients who received treatment with
Stimuvax for between 2 and 8.2 years as part of the Phase 2b trial in patients
with stage IIIb/IV non-small cell lung cancer (NSCLC).
As of the time of data analysis in April 2009, 10 of the 16 studied
patients were alive without evidence of disease progression, of whom eight
continued to receive therapy with Stimuvax after 6.3 to 8.2 years. The
remaining two living patients discontinued Stimuvax therapy after 2.4 and 5.8
years, respectively, and were without evidence of disease progression. Nine of
the 10 living patients had stage IIIb NSCLC upon entry to the trial, while one
had stage IV disease. Six of the 10 living patients had a complete response to
their first-line chemotherapy or chemo-radiation, while four patients had
stable disease. The remaining six of the 16 patients discontinued Stimuvax
after 2.0 to 5.1 years of treatment as a result of disease progression and are
Prolonged treatment with Stimuvax was well-tolerated in this trial. The
most common treatment-related adverse events were injection-site reactions,
which tended to diminish after the first year of treatment. There was no
evidence of autoimmune reactions with prolonged use.
The Phase 2b trial of Stimuvax in patients with stage IIIb/IV NSCLC was
conducted by Oncothyreon, with patient enrollment concluding in 2003.
Long-term follow-up of these patients was conducted by Merck KGaA of
Darmstadt, Germany, which assumed the clinical development of Stimuvax in
2007. Merck KGaA is responsible for the world-wide development and
commercialization of Stimuvax under license from Oncothyreon and is currently
conducting Phase 3 trials of Stimuvax in both NSCLC and breast cancer.
Stimuvax is an investigational therapeutic cancer vaccine designed to
induce an immune response to cancer cells that express MUC1, a glycoprotein
antigen widely expressed on common cancers. MUC1 is over-expressed on many
cancers such as lung cancer, breast cancer, prostate cancer and colorectal
cancer. Stimuvax is thought to work by stimulating the body's immune system to
identify and destroy cancer cells expressing MUC1.
Merck KGaA currently is conducting a global Phase 3 trial of Stimuvax
known as START (Stimulating Targeted Antigenic Responses To NSCLC). START is a
randomized, double-blind, placebo-controlled study that will evaluate patients
with documented unresectable stage III NSCLC who have had a response or stable
disease after at least two cycles of platinum-based chemo-radiotherapy. The
Phase 3 trial is expected to enroll more than 1,300 patients in over 30
countries. For more information on the START trial, or to find a participating
center and eligibility criteria, log on to www.nsclcstudy.com or
Merck KGaA is also conducting a global Phase 3 trial of Stimuvax known as
STRIDE (STimulating immune Response In aDvanced brEast cancer) in patients
with hormone receptor-positive, locally advanced, recurrent or metastatic
breast cancer. STRIDE is anticipated to enroll more than 900 patients at
approximately 180 sites in over 30 countries - including North America,
Europe, Asia and Australia.
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 future clinical
development plans for Stimuvax. 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 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. Risks, uncertainties, and assumptions include
those predicting the timing, duration and results of clinical trials, the
timing and results of regulatory reviews, the safety and efficacy of Stimuvax,
the indications for which Stimuvax might be developed, and Merck KGaA's
development plans for Stimuvax. 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.
For further information:
For further information: Investor and Media Relations Contact: Julie
Rathbun, Rathbun Communications, (206) 769-9219, firstname.lastname@example.org