SEATTLE, WA, Sept. 3, 2013 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) today
announced the initiation of an investigator-sponsored trial of ONT-380
in combination with trastuzumab (Herceptin®) in patients with brain
metastases from HER2+ breast cancer. The trial is being conducted
under the sponsorship of the Dana-Farber Cancer Institute, Boston,
Massachusetts. ONT-380 (also known as ARRY-380) is an orally active,
reversible and selective small-molecule HER2 inhibitor being developed
by Oncothyreon in collaboration with Array BioPharma Inc., Boulder,
The Phase 1 trial is a dose-escalation trial in up to 50 patients. The
primary objectives are to determine the maximum-tolerated dose and
recommended Phase 2 dose and schedule of ONT-380 in combination with
trastuzumab in patients with HER2+ breast cancer and central nervous
system (CNS) metastases. Secondary objectives include CNS objective
response rate by both RECIST and volumetric criteria, progression-free
survival and overall survival. The study will be conducted in two
parallel arms with two dose regimens of ONT-380, either once-daily or
twice-daily, in combination with standard dose trastuzumab.
"ONT-380 has demonstrated superior activity, based on overall survival,
compared to Tykerb® (lapatinib) and to the investigational drug, neratinib, in an
intracranial HER2+ breast cancer xenograft model," said Robert L.
Kirkman, M.D., President and CEO of Oncothyreon. "This provides a
strong rationale to explore whether ONT-380 can provide benefit to
patients with brain metastases, and we are pleased that the Dana Farber
Cancer Institute is undertaking this trial."
"CNS metastases, which occur in one-third to one-half of women with
metastatic HER2+ breast cancer, remain a significant clinical problem,"
said Nancy U. Lin, M.D., Principal Investigator of the Phase 1 trial
and Clinical Director, Breast Oncology, Dana-Farber Cancer Institute.
"There is an urgent need for new therapies to treat patients with brain
metastases from breast cancer, and we are excited to begin this study
ONT-380 is an orally active, reversible and selective HER2 inhibitor. In
multiple preclinical tumor models, ONT-380 was well tolerated and
demonstrated significant dose-related tumor growth inhibition that was
superior to Herceptin and Tykerb. Additionally, in these models,
ONT-380 demonstrated synergistic or additive tumor growth inhibition
when dosed in combination with the standard-of-care therapeutics
Herceptin or Taxotere® (docetaxel).
A Phase 1 trial of ONT-380, with both dose-escalation and expansion
components, has been completed in 50 patients, 43 of whom had HER2+
metastatic breast cancer. All HER2+ breast cancer patients had
progressed on a trastuzumab-containing regimen. In addition, over 80%
had been treated with lapatinib, with many having progressed on
therapy. In this study, ONT-380 demonstrated an acceptable safety
profile; treatment-related adverse events were primarily Grade 1.
Because ONT-380 is selective for HER2 and does not inhibit EGFR, there
was a low incidence and severity of treatment-related diarrhea, rash
and fatigue. Additionally, there were no treatment-related cardiac
events or Grade 4 treatment-related adverse events reported. The
maximum tolerated dose of ONT-380 established in this Phase 1 trial was
600 mg twice daily (BID). Twenty-two HER2+ breast cancer patients with
measurable disease were treated with ONT-380 at doses greater than or
equal to 600 mg BID. In this heavily pretreated patient population,
there was a clinical benefit rate (partial response [n = 3] plus stable
disease for at least 6 months [n = 3]) of 27%. Notably, two of the
patients with partial responses during treatment with ONT-380 had
confirmed progressions while on prior lapatinib- and
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.
In order to provide Oncothyreon's investors with an understanding of its
current results and future prospects, this release contains statements
that are forward-looking. Any statements contained in this press
release that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes," "anticipates,"
"plans," "expects," "will," "intends," "potential," "possible" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements include Oncothyreon's
expectations regarding clinical development activities.
Forward-looking statements involve risks and uncertainties related to
Oncothyreon's business and the general economic environment, many of
which are beyond its control. These risks, uncertainties and other
factors could cause Oncothyreon's actual results to differ materially
from those projected in forward-looking statements, including 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. Although
Oncothyreon believes that the 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 Oncothyreon's risks and uncertainties, you are encouraged to review
the documents filed with the securities regulators in the United States
on EDGAR and in Canada on SEDAR. Oncothyreon does not undertake any
obligation to publicly update its forward-looking statements based on
events or circumstances after the date hereof.
Additional information relating to Oncothyreon can be found on EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
SOURCE Oncothyreon Inc.