BELLEVUE, WA, June 17 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY)
today announced enrollment of the first patient in a Phase 1 trial of PX-866
in patients with advanced solid tumors. PX-866 is a small molecule compound
designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), an
important cell survival signaling pathway.
"PX-866 is a potent inhibitor of PI-3K, a component of a critical pathway
that is activated in many types of cancer, leading to tumor growth and
survival," said Lynn Kirkpatrick, Ph.D., Chief Scientific Officer of
Oncothyreon. "We believe that the mechanism of action of PX-866, which
irreversibly inhibits PI-3K, will have pharmacokinetic and pharmacodynamic
advantages that will distinguish PX-866 in the competitive field of PI-3K
The Phase 1 trial is expected to enroll up to 63 patients with advanced
metastatic cancer who have failed or are intolerant of standard therapy.
Patients will receive PX-866 orally once per day on days 1 through 5 and 8
through 12 during a four-week treatment cycle. Primary objectives of the study
include establishment of a maximum tolerated dose, evaluation of safety, and
analysis of the pharmacodynamic and pharmacokinetic profiles of PX-866.
"The start of the PX-866 trial represents a significant milestone for
Oncothyreon, as we now have three active clinical programs underway for our
promising small molecule inhibitors," said Robert L. Kirkman, M.D., President
and CEO of Oncothyreon. "Together with our therapeutic vaccine programs, we
have successfully established a broad and diverse oncology pipeline targeting
multiple cancer indications with substantial unmet medical need, and we look
forward to sharing the ongoing progress from these clinical programs with the
medical community and our investors."
In addition to the PX-866 trial, Oncothyreon is conducting a Phase 2
trial of PX-12, an inhibitor of thioredoxin-1, in advanced pancreatic cancer,
a Phase 1b trial of PX-12 in advanced metastatic cancer, and a Phase 1 trial
of PX-478, a small molecule inhibitor of hypoxia inducible factor-1 alpha, in
patients with advanced solid tumors or lymphomas. Oncothyreon's partner, Merck
KGaA of Darmstadt, Germany, is conducting a Phase 3 trial of Stimuvax(R), an
investigational therapeutic cancer vaccine, in patients with stage III
non-small cell lung cancer.
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
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 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.
For further information:
For further information: Investor and Media Relations Contact: Julie
Rathbun, Rathbun Communications, (206) 769-9219, email@example.com