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Oncothyreon files investigational new drug application for PX-866 oncology compound

Posted on: 05/05/2008

Oncothyreon files investigational new drug application for PX-866 oncology compound

    BELLEVUE, WA, May 1 /PRNewswire-FirstCall/ - Oncothyreon Inc. (Nasdaq:
ONTY) (TSX:ONY) today announced that it has filed an investigational new
drug (IND) application with the U.S. Food and Drug Administration for
PX-866, a small molecule phosphatidylinositol-3-kinase (PI-3-kinase)
inhibitor for the treatment of advanced cancers. Following FDA review,
Oncothyreon plans to initiate a Phase 1 clinical trial of PX-866.

    "PX-866 is a potent inhibitor of phosphatidylinositol-3-kinase that has
demonstrated preclinical anti-tumor activity in models of human ovarian
cancer, lung cancer and intracranial glioblastoma," said Lynn Kirkpatrick,
Ph.D., Chief Scientific Officer of Oncothyreon. "We believe that PX-866, an
irreversible inhibitor of the kinase, will have dose and schedule
advantages that may position it well in the current field of PI-3-kinase

    "This IND for PX-866 demonstrates the continued advancement of
Oncothyreon's small molecule oncology pipeline," said Robert L. Kirkman,
M.D., President and CEO of Oncothyreon. In addition to the planned trial of
PX-866, Oncothyreon is currently conducting a Phase 2 trial of PX-12, a
small molecule inhibitor of thioredoxin-1, in patients with advanced
pancreatic cancer and a Phase 1 trial of PX-478, a small molecule inhibitor
of HIF-1 alpha, in patients with advanced solid tumors or lymphomas.

    About PX-866

    PX-866 is an inhibitor of the PI-3-kinase/PTEN/AKT pathway, an
important survival signaling pathway that is activated in many types of
human cancer. Aberrant activation and regulation of PI-3 kinase is
implicated in a large proportion of human cancers including breast, glioma,
colon, ovarian, prostate and melanoma, where it leads to increased
proliferation and inhibition of apoptosis (programmed cell death). PX-866
has been shown to induce prolonged inhibition of tumor PI-3 kinase
signaling following both oral and intravenous administration. The compound
has been shown to have good single agent in vivo anti-tumor activity and
work well in combination with other agents in a number of human tumor

    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

    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 PX-866. 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, and the safety and efficacy of
PX-866. There can be no guarantee that the results of preclinical studies
or of early 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.

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