SEATTLE, Sept. 2 /CNW/ - Oncothyreon Inc. (NASDAQ: ONTY) (TSX: ONY) (the
"Company") today announced a prioritization plan to focus the Company's
resources on the clinical development of PX-478 and PX-866 and on process
development and manufacturing of Stimuvax(R). Oncothyreon will seek a partner
for further clinical development of PX-12 beyond the ongoing trials. The
prioritization plan is intended to concentrate Oncothyreon's efforts and
available resources on those programs with the potential for the greatest
near-term value creation for the Company's stockholders.
"This prioritization plan and the planned financing we also announced
today are intended to make it possible for us to advance both PX-478 and
PX-866 to the next stage of clinical development," said Robert L. Kirkman,
M.D., President and Chief Executive Officer of Oncothyreon. "The ongoing dose
escalation Phase 1 trial for PX-478, an inhibitor of hypoxia-inducible
factor 1 alpha, is enrolling steadily and has not yet reached a maximum dose.
The recently initiated Phase 1 trial for PX-866, an inhibitor of PI-3-kinase,
is also enrolling well. We believe the high interest in the targets of these
two compounds by both oncologists and potential partners will allow us to
create value most effectively and quickly by concentrating our limited
resources on these two programs. The next stage of development for PX-12 will
require substantial resources and time, which would be more suitable in
partnership with a larger pharmaceutical company."
"We will also continue our manufacturing and process development
activities for Stimuvax," continued Dr. Kirkman. "The Phase 3 START trial of
Stimuvax in non-small cell lung cancer is actively moving forward, and we
expect an additional large Phase 3 trial in a new indication to be initiated
later this year. To support these trials, we continue to manufacture
significant quantities of Stimuvax for our partner, Merck KGaA of Darmstadt,
Germany. Under our agreements with Merck KGaA, supplies of Stimuvax for
clinical trials are purchased exclusively from Oncothyreon. Merck KGaA is also
financially responsible for the further clinical development of Stimuvax."
"As the Stimuvax program is largely supported by Merck KGaA, we intend to
use the proceeds of the underwritten common stock offering announced today
primarily for clinical trials of PX-478 and PX-866," concluded Dr. Kirkman.
"If concluded successfully, this financing is expected to allow us to move
both programs into Phase 2 development."
PX-478 is a novel small molecule compound that inhibits the activity of
hypoxia inducible factor (HIF)-1 alpha, a component of the transcription
factor HIF-1 that controls the expression of a number of genes important for
growth and survival of cancer cells. Genes regulated by HIF-1 contribute to
diverse functions including new blood vessel growth (angiogenesis), use of
glucose for energy, and protection against apoptosis (programmed cell death).
Preclinical data have demonstrated that PX-478 can induce apoptosis in
experimental tumor models, as well as the down-regulation of factors that
control angiogenesis, such as vascular endothelial growth factor (VEGF).
PX-478 is effective when delivered orally in animal models, and has shown
marked tumor regressions and growth inhibition in model systems across a range
of cancers, including lung, ovarian, renal, prostatic, colon, pancreatic, and
breast cancer. The wide variety of models that show sensitivity to PX-478
represents a large potential market for this product candidate. The ability to
combine PX-478 with radiation therapy may further expand the opportunities for
this novel compound. Oncothyreon is currently conducting a Phase 1 trial of
PX-478 in patients with advanced metastatic cancer.
PX-866 is an inhibitor of the PI-3-kinase/PTEN/AKT pathway, an important
survival signaling pathway that is activated in many types of human cancer.
Aberrant activation and regulation of PI-3 kinase is implicated in a large
proportion of human cancers including breast, glioma, colon, ovarian, prostate
and melanoma, where it leads to increased proliferation and inhibition of
apoptosis (programmed cell death). PX-866 has been shown to induce prolonged
inhibition of tumor PI-3 kinase signaling following both oral and intravenous
administration. The compound has been shown to have anti-tumor activity both
as a single agent and in combination with other agents in a number of human
tumor models. Oncothyreon initiated a Phase 1 trial of PX-866 in patients with
advanced metastatic cancer in June 2008.
Stimuvax is an investigational therapeutic cancer vaccine designed to
induce an immune response to cancer cells that express MUC1, a glycoprotein
antigen widely expressed on common cancers. MUC1 is over expressed on many
cancers such as lung cancer, breast cancer, prostate cancer and colorectal
cancer. Stimuvax is thought to work by stimulating the body's immune system to
identify and destroy cancer cells expressing MUC1. Merck KGaA currently is
conducting a global Phase 3 trial of Stimuvax known as START (Stimulating
Targeted Antigenic Responses To NSCLC). START is a randomized, double-blind,
placebo-controlled study that will evaluate patients with documented
unresectable stage III NSCLC who have had a response or stable disease after
at least two cycles of platinum based chemo-radiotherapy. The Phase 3 trial is
expected to enroll more than 1,300 patients in approximately 30 countries. For
more information on the START trial, or to find a participating center and
eligibility criteria, log on to www.nsclcstudy.com or www.clinicaltrials.gov.
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.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy nor, shall there be any sale of these
securities in any jurisdiction in which such an offer, solicitation or sale
would be unlawful prior to registration or qualification under the securities
laws of any such jurisdiction.
In order to provide our investors with an understanding of our current
results and future prospects, this release may contain 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
our expectations regarding the offering of securities by us, our ability to
successfully execute our prioritization plan, future expenses, manufacturing
and process development activities and clinical development activities,
revenues resulting from Merck's purchase of Stimuvax supplies and the use and
adequacy of cash resources.
Forward-looking statements involve risks and uncertainties related to our
business and the general economic environment, many beyond our control. These
risks, uncertainties and other factors could cause our actual results to
differ materially from those projected in forward-looking statements,
including the risks associated with the adequacy of financing and reserves on
hand, the offering of securities by us, our ability to successfully execute
our prioritization plan, our financial condition and results of operations,
our ability to regain and maintain compliance with the listing standards of
The NASDAQ Stock Market, general economic factors, achievement of the results
we anticipate from our clinical trials with our products and our ability to
adequately obtain and protect our intellectual property rights. Although we
believe that the forward-looking statements contained herein are reasonable,
we can give no assurance that our expectations are correct. All
forward-looking statements are expressly qualified in their entirety by this
cautionary statement. For a detailed description of our risks and
uncertainties, 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 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 U.S. EDGAR
at www.sec.gov and on SEDAR at www.sedar.com.
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For further information: Investor and Media Relations Contact: Julie
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