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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
Date:11/18/2010

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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 an
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