Oncothyreon Reports Positive Data from Phase 1 Clinical Trial of PI3-Kinase Inhibitor PX-866 in Patients with Relapsed or Refractory Solid Tumors
SEATTLE, November 18, 2010 /PRNewswire-FirstCall/ -Oncothyreon Inc. 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 Cancer Center, Aurora, Colorado, at the 22(nd) 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.
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/m(2) 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.
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).
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.
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Posted: November 2010