SEATTLE, WA, Sept. 12, 2011 /CNW/ - Oncothyreon Inc. (Nasdaq: ONTY)
today announced enrollment of the first patient in a Phase 2 trial of
PX-866 in patients with recurrent or metastatic castration-resistant
prostate cancer. 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 open label Phase 2 trial is being conducted by the NCIC Clinical
Trials Group (NCIC CTG), Queen's University in Kingston, Canada. The
trial will enroll approximately 40 patients with castration-resistant
prostate cancer who have received no prior chemotherapy. The primary
endpoint of this single-arm screening trial is the proportion of
patients with lack of disease progression at 12 weeks from the
initiation of therapy with PX-866.
"We look forward to evaluating PX-866 in this group of prostate cancer
patients who no longer respond to hormone therapy and for which new
treatment agents are needed," said Kim Chi, M.D., Co-chair of the NCIC
CTG study. "We believe PX-866 is an interesting therapeutic target for
evaluation given that deregulation of the PI3K pathway has been widely
implicated in castration-resistant prostate cancer."
"We appreciate the support and interest of the NCIC CTG in initiating
the second single-agent Phase 2 clinical trial evaluating PX-866, our
novel, irreversible PI-3K inhibitor," said Robert L. Kirkman, M.D.,
President and CEO of Oncothyreon. "We now have four clinical trials of
PX-866 underway, evaluating this agent in a variety of treatment
settings and tumor types. We believe this broad Phase 2 program will
provide significant information to guide later stage development of
this product candidate."
PX-866 is a pan 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).
Oncothyreon is conducting a broad development program of PX-866 as a
single agent and in combination with other agents in multiple cancer
types. Current trials include a Phase 1/2 trial of PX-866 in
combination with cetuximab (Erbitux®) in patients with metastatic
colorectal carcinoma or progressive, recurrent or metastatic squamous
cell carcinoma of the head and neck (SCCHN) and a Phase 1/2 trial of
PX-866 in combination with the chemotherapeutic agent docetaxel in
patients with locally advanced, recurrent or metastatic non-small cell
lung cancer or SCCHN. In addition, the NCIC Clinical Trials Group is
conducting two Phase 2 trials, the trial in patients with recurrent or
metastatic castration- resistant prostate cancer described above and a
trial in patients with glioblastoma multiforme that has recurred during
or following primary therapy.
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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