Oncothyreon Advances To Phase 2 Portion Of Phase 1/2 Trial Of PX-866 In Combination With Docetaxel
Oncothyreon Inc. recently announced it has initiated the Phase 2 portion of its ongoing Phase 1/2 trial of PX-866 in combination with the chemotherapeutic agent docetaxel (Taxotere) following successful completion of the Phase 1 dose escalation portion of the study. PX-866 is a small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway.
The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated or recommended daily dose of PX-866 to be given in combination with the standard dose of docetaxel administered once every three weeks to patients with advanced cancers for which docetaxel is considered standard of care. The Phase 1 portion enrolled a total of 43 patients treated at 3 different dose levels of PX-866 in combination with the standard dose of docetaxel. Preliminary results indicated that combination treatment was well tolerated and associated with an encouraging disease control rate. The recommended daily dose of PX-866 in combination with docetaxel was determined to be the same as the single agent daily maximum tolerated dose. Additional results from the Phase 1 portion of the trial will be submitted for presentation at an upcoming scientific meeting.
The Phase 2 portion of the trial is an open-label, randomized evaluation of the antitumor activity and safety of PX-866 administered at the recommended daily dose in combination with docetaxel, versus docetaxel alone, in two groups of patients. Group 1 will enroll patients with non-small lung cancer receiving second or third line treatment. Group 2 will enroll patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck after failure of prior therapy. The two groups will be randomized and evaluated independently.
Up to 170 patients may be enrolled in the Phase 2 portion of the study including 88 (44 per arm) in Group 1 and 82 patients (41 per arm) in Group 2. The primary endpoint of the Phase 2 portion is progression free survival. Secondary endpoints include objective response rate and overall survival. Additional information on the trial is available at clinicaltrials.gov.
About PX-866
PX-866 is a pan inhibitor of the PI-3K/PTEN/AKT pathway, a critical cell signaling pathway that is activated in many types of human cancer. Aberrant activation and regulation of PI-3K is implicated in a large proportion of human cancers, where it leads to increased proliferation and inhibition of apoptosis (programmed cell death).
Oncothyreon is conducting a broad development program of PX-866 as a single agent and in combination with other agents in multiple cancer types. In addition to the randomized Phase 1/2 trial of PX-866 in combination with docetaxel described above, other current trials include a randomized Phase 1/2 trial of PX-866 in combination with cetuximab (Erbitux) in patients with metastatic colorectal carcinoma or progressive, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In addition, the NCIC Clinical Trials Group is conducting two Phase 2 trials, glioblastoma multiforme that has recurred during or following primary therapy and one in patients with recurrent or metastatic castration-resistant prostate cancer.
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 www.oncothyreon.com.