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"PX-866 is a potent inhibitor of PI-3K, a component of a critical pathwaythat is activated in many types of cancer, leading to tumor growth andsurvival," said Lynn Kirkpatrick, Ph.D., Chief Scientific Officer ofOncothyreon. "We believe that the mechanism of action of PX-866, whichirreversibly inhibits PI-3K, will have pharmacokinetic and pharmacodynamicadvantages that will distinguish PX-866 in the competitive field of PI-3Kinhibitors."
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The Phase 1 trial is expected to enroll up to 63 patients with advancedmetastatic 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 8through 12 during a four-week treatment cycle. Primary objectives of the studyinclude establishment of a maximum tolerated dose, evaluation of safety, andanalysis of the pharmacodynamic and pharmacokinetic profiles of PX-866.
"The start of the PX-866 trial represents a significant milestone forOncothyreon, as we now have three active clinical programs underway for ourpromising small molecule inhibitors," said Robert L. Kirkman, M.D., Presidentand CEO of Oncothyreon. "Together with our therapeutic vaccine programs, wehave successfully established a broad and diverse oncology pipeline targetingmultiple cancer indications with substantial unmet medical need, and we lookforward to sharing the ongoing progress from these clinical programs with themedical community and our investors."
In addition to the PX-866 trial, Oncothyreon is conducting a Phase 2 trialof PX-12, an inhibitor of thioredoxin-1, in advanced pancreatic cancer, aPhase 1b trial of PX-12 in advanced metastatic cancer, and a Phase 1 trial ofPX-478, a small molecule inhibitor of hypoxia inducible factor-1 alpha, inpatients with advanced solid tumors or lymphomas. Oncothyreon's partner, MerckKGaA of Darmstadt, Germany, is conducting a Phase 3 trial of Stimuvax(R), aninvestigational therapeutic cancer vaccine, in patients with stage IIInon-small cell lung cancer.
About PX-866
PX-866 is an inhibitor of the PI-3-kinase/PTEN/AKT pathway, an importantsurvival signaling pathway that is activated in many types of human cancer.Aberrant activation and regulation of PI-3 kinase is implicated in a largeproportion of human cancers including breast, glioma, colon, ovarian, prostateand melanoma, where it leads to increased proliferation and inhibition ofapoptosis (programmed cell death). PX-866 has been shown to induce prolongedinhibition of tumor PI-3 kinase signaling following both oral and intravenousadministration. The compound has been shown to have anti-tumor activity bothas a single agent and in combination with other agents in a number of humantumor models.
About Oncothyreon
Oncothyreon is a biotechnology company specializing in the development ofinnovative therapeutic products for the treatment of cancer. Oncothyreon'sgoal is to develop and commercialize novel synthetic vaccines and targetedsmall molecules that have the potential to improve the lives and outcomes ofcancer patients. For more information, visit www.oncothyreon.com.
Forward Looking Statements
In order to provide Oncothyreon's investors with an understanding of itscurrent intentions and future prospects, this release contains statements thatare forward looking, including statements related to future clinicaldevelopment plans for PX-866. These forward-looking statements representOncothyreon's intentions, plans, expectations and beliefs and are based on itsmanagement's expe
