Enrollment complete in Oncolytics REOLYSIN combination trial for head and neck cancers

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) announced today that it has completed enrollment in the first, 80 patient stage of its Phase III clinical trial examining REOLYSIN^® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018).

"This is an important milestone for this study," said Dr. Brad Thompson, President and CEO of Oncolytics. "A data analysis that will involve examining evolving progression free survival will now be performed on this patient group to determine the probability of success in the second stage of the study."

The randomized, two-arm, double-blind, multi-centre, two-stage, adaptive Phase III trial will assess the intravenous administration of REOLYSIN with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. All patients will receive treatment every three weeks (21 day cycles) with paclitaxel and carboplatin and will also receive, on a blinded basis, either intravenous placebo or intravenous REOLYSIN. All dosing takes place in the first five days of each cycle, with all patients receiving standard intravenous doses of paclitaxel and carboplatin on day one only, and on days one through five, either intravenous placebo or intravenous REOLYSIN at a dose of 3x10¹⁰ TCID₅₀. Patients may continue to receive the trial combination therapy for up to eight, 21-day cycles and, thereafter, blinded placebo or blinded REOLYSIN until the patient has progressive disease or meets other criteria for removal from the trial.

The primary endpoint for the trial is overall survival (OS). Secondary endpoints include progression free survival (PFS), objective response rate (complete response (CR) + partial response (PR)) and duration of response, and safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin. The first stage of the trial is non-adaptive, and was designed to enroll 80 patients. The second stage is adaptive, and is designed to enroll between 100 and 400 patients with the most probable statistical enrollment being 195 patients in this stage. This adaptive trial design allows data evaluation to determine if the probability of reaching a statistically significant endpoint has been achieved.

The trial is currently being conducted in more than 80 centres in 12 countries in North America and Europe, including the U.S. following an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process with respect to the trial's design.