Phase 3 Trial Examining REOLYSIN® In Combination With Paclitaxel And Carboplatin In Patients With Platinum-Refractory Head And Neck Cancers

Oncolytics announced in October 2009 that it had reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data, that depending upon outcome, could support a license application submission for REOLYSIN.

As specified in the SPA, the randomized, two-arm, double-blind, multicentre, two-stage, adaptive Phase 3 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 3 x 10¹⁰ 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 is 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 enrolment being 195 patients in this stage. This adaptive trial design allows frequent data evaluation to determine if the probability of reaching a statistically significant endpoint has been achieved.

See related press releases and documents:

July 19, 2010 - Oncolytics Biotech® Inc. Receives No Objection Letter from Health Canada to Conduct Phase 3 Trial of REOLYSIN® in Head and Neck Cancers

June 1, 2010 - Oncolytics Biotech® Inc. Receives Approval from Belgium FAMHP to Conduct Phase 3 Trial for REOLYSIN® in Head and Neck Cancers

May 25, 2010 - Oncolytics Biotech® Inc. Announces Opening of Enrollment in Phase 3 Trial for REOLYSIN® in Head and Neck Cancers

February 16, 2010 - Oncolytics Biotech® Inc. Receives Approval from the U.K. MHRA to Conduct Phase 3 Trial for REOLYSIN® in Head and Neck Cancers --Company to Host Clinical Update Conference Call

October 2, 2009 - Oncolytics Biotech® Inc. Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN® in Head and Neck Cancers --Company to Host Conference Call--