PX-866

Phase 1 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 is conducting a Phase 1 trial of PX-866 in patients with advanced metastatic cancer. The Phase 1 trial is expected to enroll up to 63 patients with advanced metastatic cancer who have failed or are intolerant of standard therapy. Patients will receive PX-866 orally once per day on days 1 through 5 and 8 through 12 or days 1-28 of a 28 day cycle, until progression or development of unacceptable toxicity. Primary objectives of the study include establishment of a maximum tolerated dose, evaluation of safety, and analysis of the pharmacodynamic and pharmacokinetic profiles of PX-866. For information on PX-866 clinical trials, please visit PX-866 Phase 1 trial description posted on ClinicalTrials.gov.