Oncothyreon Advances to Phase 2 Portion of Phase 1/2 Trial of PX-866 in Combination with Docetaxel
SEATTLE, WA, Oct. 20, 2011 /PRNewswire/ – Oncothyreon Inc. (Nasdaq: ONTY) today
announced it has initiated the Phase 2 portion ofÂ its ongoing Phase
1/2 trial of PX-866 in combination with the chemotherapeutic agent
docetaxel (Taxotere(Â®))( )following successful completion of the Phase 1 dose escalation portion
of the study. 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 primary objective of the Phase 1 portion of the trial was to
determine the maximum tolerated or recommended daily dose of PX-866 to
be given in combination with the standard dose of docetaxel
administered once every three weeks to patients with advanced cancers
for which docetaxel is considered standard of care. The Phase 1 portion
enrolled a total of 43 patients treated at 3 different dose levels of
PX-866 in combination with the standard dose of docetaxel. Preliminary
results indicated that combination treatment was well tolerated and
associated with an encouraging disease control rate. The recommended
daily dose of PX-866 in combination with docetaxel was determined to be
the same as the single agent daily maximum tolerated dose.Â Additional
results from the Phase 1 portion of the trial will be submitted for
presentation at an upcoming scientific meeting.
The Phase 2 portion of the trial is an open-label, randomized evaluation
of the antitumor activity and safety of PX-866 administered at the
recommended daily dose in combination with docetaxel, versus docetaxel
alone, in two groups of patients.Â Group 1 will enroll patients with
non-small lung cancer receiving second or third line treatment. Group 2
will enroll patients with locally advanced, recurrent or metastatic
squamous cell carcinoma of the head and neck after failure of prior
therapy. The two groups will be randomized and evaluated independently.
Up to 170 patients may be enrolled in the Phase 2 portion of the study
including 88 (44 per arm) in Group 1 and 82 patients (41 per arm) in
Group 2. The primary endpoint of the Phase 2 portion is progression
free survival. Secondary endpoints include objective response rate and
overall survival.Â Additional information on the trial is available at clinicaltrials.gov.
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).
OncothyreonÂ is conducting a broad development program of PX-866 as a
single agent and in combination with other agents in multiple cancer
types. In addition to the randomized Phase 1/2 trial of PX-866 in
combination with docetaxel described above, other current trials
include a randomized Phase 1/2 trial of PX-866 in combination with
cetuximab (ErbituxÂ®) in patients with metastatic colorectal carcinoma
or progressive, recurrent or metastatic squamous cell carcinoma of the
head and neckÂ (SCCHN). In addition, the NCIC Clinical Trials Group is
conducting two Phase 2 trials, glioblastoma multiforme that has
recurred during or following primary therapy and one in patients with
recurrent or metastatic castration-resistant prostate cancer.
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 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.
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SOURCE Oncothyreon Inc.