SEATTLE, WA, April 5 /CNW/ - Oncothyreon Inc. (NASDAQ: ONTY) today
announced enrollment of the first patient in a Phase 2 trial of PX-866
in patients with glioblastoma multiforme that has recurred during or
following primary therapy. PX-866 is a small molecule compound designed
to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a
component of an important cell survival signaling pathway.
The Phase 2 trial is being conducted at 7 Canadian centers by the NCIC
Clinical Trials Group (NCIC CTG), Queen's University in Kingston,
Canada. The trial will enroll up to 30 patients whose brain tumor is
in first relapse during or following primary therapy. The primary
endpoint of this single-arm screening trial is a combination of
objective response rate and early progression.
"We are pleased to conduct this trial of PX-866 in patients with a
recurrence of this difficult type of brain malignancy, for whom current
treatment options are very limited and novel treatments are highly
valued," said Marshall Pitz, M.D., Chair of the NCIC Clinical Trials
Group study. "We are particularly interested in PX-866, because
mutations in the signaling pathway that includes PI-3K are relatively
common in patients with glioblastoma."
"We are grateful to the NCIC CTG for conducting this study of PX-866,"
said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "As
previously indicated, we are committed to a broad Phase 2 development
program for PX-866, in combination with other agents, as a single
agent, and in multiple tumor types, to maximize our opportunity to
demonstrate the utility of this novel, irreversible PI-3K inhibitor."
PX-866 is an inhibitor of the PI-3K/PTEN/AKT pathway, a critical cell
signaling pathway that is activated in many types of human cancer.
Aberrant activation and regulation of PI-3K is implicated in a large
proportion of human cancers, where it leads to increased proliferation
and inhibition of apoptosis (programmed cell death). Results from a
single-agent Phase 1 open-label, dose escalation study of PX-866 in
patients with advanced metastatic cancer presented at the American
Society of Clinical Oncology earlier this year demonstrated that PX-866
was well tolerated using both an intermittent and continuous (daily)
dosing schedule. Additional data from the Phase 1 trial presented at
the EORTC/NCI/AACR meeting in Berlin on November 18, 2010 demonstrated
that 8 of 19 evaluable patients treated with continuous dosing achieved
stable disease as their best response.
About the NCIC Clinical Trials Group
The NCIC Clinical Trials Group (NCIC CTG) is a cancer clinical trials
cooperative group that conducts phase I-III trials testing anti-cancer
and supportive therapies across Canada and internationally. It is one
of the national programmes and networks of the Canadian Cancer Society
Research Institute (CCSRI), and is supported by the CCSRI with funds
raised by the Canadian Cancer Society (CCS). The NCIC CTG's Central
Office is located at Queen's University in Kingston, Ontario, Canada.
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
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.
SOURCE Oncothyreon Inc.
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