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Oncothyreon files investigational new drug application for PX-866 oncology compound Print E-mail
01 May 2008

Oncothyreon Inc. today announced that it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for PX-866, a small molecule phosphatidylinositol-3-kinase (PI-3-kinase) inhibitor for the treatment of advanced cancers

BELLEVUE, WA, USA | May 1, 2008 | Oncothyreon Inc. (Nasdaq: ONTY) (TSX:ONY) today announced that it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for PX-866, a small molecule phosphatidylinositol-3-kinase (PI-3-kinase) inhibitor for the treatment of advanced cancers. Following FDA review, Oncothyreon plans to initiate a Phase 1 clinical trial of PX-866.

"PX-866 is a potent inhibitor of phosphatidylinositol-3-kinase that has demonstrated preclinical anti-tumor activity in models of human ovarian cancer, lung cancer and intracranial glioblastoma," said Lynn Kirkpatrick, Ph.D., Chief Scientific Officer of Oncothyreon. "We believe that PX-866, an irreversible inhibitor of the kinase, will have dose and schedule advantages that may position it well in the current field of PI-3-kinase inhibitors."

"This IND for PX-866 demonstrates the continued advancement of Oncothyreon's small molecule oncology pipeline," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. In addition to the planned trial of PX-866, Oncothyreon is currently conducting a Phase 2 trial of PX-12, a small molecule inhibitor of thioredoxin-1, in patients with advanced pancreatic cancer and a Phase 1 trial of PX-478, a small molecule inhibitor of HIF-1 alpha, in patients with advanced solid tumors or lymphomas.

About PX-866

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 good single agent in vivo anti-tumor activity and work well in combination with other agents in a number of human tumor models.

About Oncothyreon

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.

SOURCE: Oncothyreon Inc.





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