SEATTLE, WA, Dec. 20, 2011 /PRNewswire/ -Oncothyreon Inc. (Nasdaq: ONTY) today announced the filing of an
Investigational New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) for ONT-10, a therapeutic vaccine directed at
cancers expressing MUC1. Upon completion of the FDA's review of the
IND, Oncothyreon expects to initiate a Phase 1 trial of ONT-10.
"We are pleased to announce the filing of this IND, which is a
significant milestone for our therapeutic vaccine development program,"
said Robert L. Kirkman, M.D., President and Chief Executive Officer of
Oncothyreon. "ONT-10 and its adjuvant component, PET-Lipid A, were
internally discovered and developed and remain fully owned by
ONT-10 is a therapeutic vaccine targeting MUC1, a tumor-associated
antigen present on many types of human malignant tumors, including
lung, breast, colorectal, prostate and ovarian cancer. ONT-10 was
designed to stimulate both the humoral and cellular arms of the immune
response. Preclinical results demonstrated that administration of
ONT-10 produces a robust antibody response in mice specific for human
tumor MUC1. A strong cellular immune response directed to the target
was also shown. Additionally, the adjuvant component of ONT-10,
PET-Lipid A, a fully synthetic toll like receptor 4 (TLR4) agonist
discovered by Oncothyreon, was shown to have enhanced potency compared
to the adjuvant monophosphoryl lipid A (MPL).
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.
SOURCE Oncothyreon Inc.