ONTY starts four-Phase II trial program with its oral PI3K inhibitor: The company announced this morning the initiation of its four-Phase II trial program with PX-866, its oral, irreversible inhibitor of PI3K. The first of the four Phase II studies is a Phase I/II trial in combination with docetaxel in patients with NSCLC and head & neck cancer.

Trial details: This will be an open-label trial that will enroll up to 117 patients (if the Phase II portion of the trial ends up including a third arm). The Phase I portion of the trial will be a dose-escalation trial to determine safety and the MTD of qd PX-866 in combination with standard dose docetaxel q3w in patients with advanced solid tumors. The Phase II portion will have two arms: the first in 2nd and 3rd line NSCLC patients and the second in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. The Phase II portion of the trial may include a third arm based on data from the Phase I part of the trial. The primary endpoint of the Phase II portion of the trial will be a combination of ORR and early progression rate, with duration of response, disease control rate and PFS as secondary endpoints.

ONTY is testing PX-866 in a broad, four-Phase II trial program in solid tumors.

In addition to the Phase I/II trial just announced, Oncothyreon will test its oral, irreversible inhibitor of PI3K three more Phase II studies, two of which will be conducted by the Canadian NCI's Clinical Trials Group.

1) The company is also planning to start a Phase II trial of PX-866 in combination with another targeted, currently undisclosed, agent in late 2010.

In addition, Oncothyreon has announced it expects that the National Cancer Institute of Canada Clinical Trials Group will conduct two additional trials with PX-866:

2) a Phase II trial of PX-866 in prostate cancer (CRPC), and

3) a Phase II trial of PX-866 in relapsed gliobastoma.

3Q10 Earnings call info: Monday, November 8, 2010 at 4:30pm ET. Dial in: (877) 280-7291 (US), (707) 287-9361 (International).

First peak into Phase III START trial expected around YE2010: Even though we don't expect the first interim look to provide many definite answers, we view it as fairly significant because it may address safety concerns, with the outside chance (~10-15% in our view) of providing an answer as to the vaccine's efficacy. We don't expect the timing of the first interim look to be affected by the clinical hold, since it is an event-based milestone, triggered when 50% of the deaths have occurred, and we still expect it by YE 2010.

We reiterate our Market Outperform rating and $8 target price on ONTY. We reach our $8/share 12-month price target using a comparables valuation methodology.

Source:
Oncothyreon Inc.