Oncothyreon Initiates Phase 2 Trial of its PI-3 Kinase Inhibitor PX-866 in Patients with Prostate Cancer

Sep 12, 2011, 08:05 ET from Oncothyreon Inc.

SEATTLE, WA, Sept. 12, 2011 /PRNewswire/ - Oncothyreon Inc. (Nasdaq: ONTY) today announced enrollment of the first patient in a Phase 2 trial of PX-866 in patients with recurrent or metastatic castration-resistant prostate cancer. 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 open label Phase 2 trial is being conducted by the NCIC Clinical Trials Group (NCIC CTG), Queen's University in Kingston, Canada.  The trial will enroll approximately 40 patients with castration-resistant prostate cancer who have received no prior chemotherapy.  The primary endpoint of this single-arm screening trial is the proportion of patients with lack of disease progression at 12 weeks from the initiation of therapy with PX-866.

"We look forward to evaluating PX-866 in this group of prostate cancer patients who no longer respond to hormone therapy and for which new treatment agents are needed," said Kim Chi, M.D., Co-chair of the NCIC CTG study. "We believe PX-866 is an interesting therapeutic target for evaluation given that deregulation of the PI3K pathway has been widely implicated in castration-resistant prostate cancer."

"We appreciate the support and interest of the NCIC CTG in initiating the second single-agent Phase 2 clinical trial evaluating PX-866, our novel, irreversible PI-3K inhibitor," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "We now have four clinical trials of PX-866 underway, evaluating this agent in a variety of treatment settings and tumor types. We believe this broad Phase 2 program will provide significant information to guide later stage development of this product candidate."

About PX-866

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).

Oncothyreon is conducting a broad development program of PX-866 as a single agent and in combination with other agents in multiple cancer types. Current trials include a Phase 1/2 trial of PX-866 in combination with cetuximab (Erbitux®) in patients with metastatic colorectal carcinoma or progressive, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) and a Phase 1/2 trial of PX-866 in combination with the chemotherapeutic agent docetaxel in patients with locally advanced, recurrent or metastatic non-small cell lung cancer or SCCHN. In addition, the NCIC Clinical Trials Group is conducting two Phase 2 trials, the trial in patients with recurrent or metastatic castration- resistant prostate cancer described above and a trial in patients with glioblastoma multiforme that has recurred during or following primary therapy.

About the NCIC Clinical Trials Group

The NCIC Clinical Trials Group (NCIC CTG) is a cancer clinical trials cooperative group that conducts phase I-III trials testing anti-cancer and supportive therapies across Canada and internationally. It is one of the national programmes and networks of the Canadian Cancer Society Research Institute (CCSRI), and is supported by the CCSRI with funds raised by the Canadian Cancer Society (CCS).  The NCIC CTG's Central Office is located at Queen's University in Kingston, Ontario, Canada.

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.

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 preclinical and 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.