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Oncolytics Biotech(R) Inc. Receives Approval from the U.K. MHRA to Conduct Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers
Date:2/16/2010

-- Company to Host Clinical Update Conference Call --

CALGARY, Feb. 16 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that the Company previously reached an agreement on with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process.

"Receipt of this approval clears the way for final preparations at the participating centres in anticipation of the start of enrolment in this trial and we expect to provide an update on timing in the near future," said Dr. Brad Thompson, President and CEO of Oncolytics. "Conducting this trial in both the U.S. and Europe allows us to access many of the physicians that have worked with REOLYSIN previously and, if the trial is successful, provides us with the basis for regulatory submissions in both the key American and European markets."

As previously disclosed, 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 wil
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