SEATTLE, June 22 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY) (the
"Company") today announced that Merck KGaA of Darmstadt, Germany, has
initiated a global Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine,
L-BLP25) in patients with hormone receptor-positive, locally advanced,
recurrent or metastatic breast cancer. Stimuvax is an investigational
therapeutic cancer vaccine being developed by Merck KGaA under a license
agreement with Oncothyreon.
The Phase 3 trial, named STRIDE (STimulating immune Response In aDvanced
brEast cancer), is anticipated to enroll more than 900 patients at
approximately 180 sites in over 30 countries - including North America,
Europe, Asia and Australia. Patients with estrogen receptor-positive and/or
progesterone receptor-positive, non-resectable locally advanced, recurrent or
metastatic breast cancer receiving hormonal therapy will be randomized to
receive either Stimuvax or a placebo in a 2:1 ratio. The primary endpoint of
STRIDE is progression-free survival. Overall survival, quality of life, tumor
response and safety will also be assessed in this study.
"Advanced-stage breast cancer remains a devastating and challenging
disease and we urgently need new treatment options," said Dr. Larry Shulman,
Chief Medical Officer and Senior Vice President for Medical Affairs,
Dana-Farber Cancer Institute, Boston, Massachusetts, and Principal
Investigator of STRIDE. "If the results from the Phase 3 STRIDE study prove
positive, this could make a difference for patients with hormone receptor
positive metastatic breast cancer."
"The initiation of the STRIDE study is an enormous step forward in
clinical breast cancer research and represents our continued commitment to
developing Stimuvax within a robust clinical trial program across several
cancer types. We are very excited that Stimuvax will now be tested in two
different cancer types in Phase III," said Dr. Oliver Kisker, Senior
Vice-President, Global Clinical Development Unit Oncology, Merck KGaA.
"We are very pleased by the robust development program our partner, Merck
KGaA, is conducting for Stimuvax," said Robert L. Kirkman, M.D., President and
Chief Executive Officer of Oncothyreon. "The addition of the Phase 3 STRIDE
trial in breast cancer to the Phase 3 START trial in non-small cell lung
cancer (NSCLC) is evidence of their strong commitment to this innovative
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.
In addition to STRIDE, 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. START is expected to enroll more than 1,300 patients in
over 30 countries. For more information on the START trial log on to
www.nsclcstudy.com or www.clinicaltrials.gov.
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 Serono'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