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Oncothyreon Reports Positive Data from Phase 1 Clinical Trial of PI3-Kinase Inhibitor PX-866 in Patients with Relapsed or Refractory Solid Tumors

Oncothyreon Reports Positive Data from Phase 1 Clinical Trial of PI3-Kinase Inhibitor PX-866 in Patients with Relapsed or Refractory Solid Tumors

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Oncothyreon Reports Positive Data from Phase 1 Clinical Trial of PI3-Kinase Inhibitor PX-866 in Patients with Relapsed or Refractory Solid Tumors


SEATTLE, Nov. 18 /PRNewswire-FirstCall/ - Oncothyreon Inc. (Nasdaq: ONTY) today reported updated results from a Phase 1 clinical trial of PX-866, an irreversible small molecule phosphatidylinositol-3-kinase (PI-3K) inhibitor, in patients with advanced solid tumors. The results were presented by Antonio Jimeno, M.D., Ph.D., of the University of Colorado Cancer Center, Aurora, Colorado, at the 22nd EORTC/NCI/AACR Symposium on "Molecular Targets and Cancer Therapeutics" in Berlin, Germany.

Data highlighted were from the continuous dosing arm of the single-agent, Phase 1 open-label, dose escalation study of PX-866 in patients with advanced solid tumors who had failed or were intolerant of standard therapy. In the continuous dosing arm, patients received oral doses of 8 mg or 10 mg of PX-866 once daily. Eight of 19 evaluable patients (42 percent) achieved stable disease as their best response. Three patients remain on study, including one patient with prostate cancer who has been on therapy for more than 10 months. 

"It is promising to see evidence of long-term disease control and tolerance of a continuous dosing treatment regimen in this early stage trial involving advanced cancer patients who had failed multiple prior therapies," said Dr. Jimeno. "We look forward to further clinical evaluation of this novel, irreversible PI-3K inhibitor in the recently initiated Phase 1/2 trial of PX-866 and docetaxel as well as in additional clinical trials."

PX-866 was well tolerated in this trial, with the majority of adverse events mild to moderate in severity. The most common adverse events included diarrhea, nausea, vomiting, fatigue and reversible elevation of liver enzymes. There were no significant adverse hematologic events and no increase in adverse events noted in patients receiving more than two cycles of treatment. Pharmacokinetic analysis confirmed that PX-866 is rapidly metabolized to a more potent derivative. PX-866 Development Program Oncothyreon has initiated a Phase 1/2 trial of PX-866 in combination with docetaxel and plans to begin three additional Phase 1/2 and Phase 2 trials of PX-866 in multiple tumor types, either in combination with another targeted agent or as a single agent.

The ongoing Phase 1/2 combination trial includes a dose escalation of PX-866 in combination with docetaxel administered at the standard dose of 75 mg/m2 in patients with advanced cancer for which docetaxel is considered standard of care. Once the recommended dose of PX-866 in combination with docetaxel is established, the Phase 2 portion will consist of two independent arms examining PX-866 in combination with docetaxel in second or third line non-small cell lung cancer and in second or third line squamous cell carcinoma of the head and neck. About PX-866 PX-866 is an irreversible inhibitor of the PI-3-kinase/PTEN/AKT pathway, a critical cell 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, where it leads to increased proliferation and inhibition of apoptosis (programmed cell death). 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 href="">

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 its 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 Oncothyreon's 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 Oncothyreon's product candidates, and the indications for which Oncothyreon's 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.
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