Oncothyreon announces clinical data from three product candidates presented at American Society of Clinical Oncology (ASCO) Annual Meeting



    SEATTLE, WA, May 30 /CNW/ - Oncothyreon Inc. (Nasdaq:   ONTY) (TSX:ONY)
(the "Company") today announced that data from clinical trials for three of
the Company's product candidates were presented at the American Society of
Clinical Oncology (ASCO) Annual Meeting on May 30, 2009 in Orlando, Florida.
The presentations included long-term safety data from the Phase 2b trial of
Stimuvax(R) in patients with stage IIIB/IV non-small cell lung cancer,
preliminary results from the Phase 1 trial of the phosphoinositide-3-kinase
(PI-3 kinase) inhibitor PX-866 in patients with advanced malignancy, and final
results from two Phase 1b trials of the thioredoxin inhibitor PX-12 in
advanced cancer patients.

    Stimuvax

    Data concerning the long-term safety of Stimuvax (BLP25 liposomal
vaccine) were presented by Dr. Charles Butts, Cross Cancer Institute,
Edmonton, Alberta. Sixteen patients who received 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) were studied. Ten of these patients have
been treated for more than five years, and eight continue to receive therapy
with Stimuvax. 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.
    "We are very pleased that this group of long-term survivors with advanced
NSCLC has been able to continue to receive Stimuvax with apparent safety for
up to eight years," said Robert L. Kirkman, M.D., President and Chief
Executive Officer of Oncothyreon. "These patients were treated as part of the
randomized Phase 2b trial conducted by Oncothyreon, in which the subset of
patients with Stage IIIb locoregional disease who received Stimuvax had a
median survival of 30.6 months compared with 13.3 months for similar patients
who did not receive the vaccine, a difference of 17.3 months. Long-term
follow-up of these patients was conducted by Merck KGaA of Darmstadt, Germany,
which assumed responsibility for the clinical development of Stimuvax in
2007."
    Merck KGaA 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.

    PX-866

    Preliminary results of Oncothyreon's ongoing Phase 1 trial of PX-866, an
inhibitor of PI-3 kinase, were presented by Dr. Antonio Jimenez, University of
Colorado Cancer Center, Aurora, Colorado. Twenty-six patients have been
treated in this trial at once daily doses ranging from 0.5 mg to 10 mg. The
maximally tolerated dose has not yet been identified. The most common
treatment-related adverse events at the doses tested include low-grade nausea,
vomiting and diarrhea. Of 24 evaluable patients, six patients with previously
progressive disease have had stable disease as their best response. Three of
these patients remain on therapy. Pharmacodynamic monitoring has demonstrated
inhibition of PI-3 kinase activity at doses as low as 1 mg per patient.
    "We are excited to have seen stabilization of disease in previously
progressing patients, as well as clearcut inhibition of PI-3 kinase activity,
even in the early cohorts in this dose escalation trial," said Dr. Kirkman.
"We believe these findings may reflect the fact that PX-866 is an irreversible
inhibitor of PI-3 kinase, which distinguishes it from other PI-3 kinase
inhibitors currently in clinical development."

    PX-12

    Final results from two Phase 1b trials of PX-12, an inhibitor of
thioredoxin, were presented by Dr. R.K. Ramanathan, Scottsdale Clinical
Research Center, Scottsdale, Arizona. These trials in 32 patients were
designed to assess the tolerability and pharmacodynamic activity of both
24-hour and 72-hour infusions of PX-12. In both trials, doses up to 400
mg/m(2)/day were well-tolerated. PX-12 was shown to lower levels of
circulating thioredoxin in patients whose starting levels were at least
three-fold greater than normal. Three patients achieved stable disease.

    About Stimuvax

    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 www.clinicaltrials.gov.

    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 anti-tumor activity both
as a single agent and in combination with other agents in a number of human
tumor models. Oncothyreon initiated a Phase 1 trial of PX-866 in patients with
advanced metastatic cancer in June 2008.

    About PX-12

    PX-12 is a small molecule irreversible inhibitor of the redox protein
thioredoxin. Thioredoxin is involved in the first unique step in DNA
synthesis. Thioredoxin also provides control over a number of transcription
factors affecting cell proliferation and death through the mechanism of redox
regulation.
    An initial Phase 1 trial involving 38 patients with advanced metastatic
cancer showed that PX-12 was well tolerated and produced a decrease in plasma
concentrations of thioredoxin that was significantly correlated with increased
patient survival. Fifteen of the 38 patients achieved stable disease of up to
322 days. A randomized Phase 2 trial comparing two dose levels of PX-12 in up
to 80 patients at three sites with advanced pancreatic cancer who have
progressed on gemcitabine or a gemcitabine-containing regimen was initiated in
January 2007. Enrollment in this trial was terminated in early 2009. The
Company intends to seek a partner for further development of this drug
candidate.

    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 future preclinical and
clinical development plans for our product candidates. 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 our
product candidates, and the indications for which our product candidates might
be developed. 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, ir@oncothyreon.com

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