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Oncolytics Biotech(R) Inc. Announces Opening of Enrollment in Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers
Date:5/25/2010

CALGARY, May 25 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it has opened enrollment in its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The Company had previously received approval from the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct the trial in those countries, respectively. Oncolytics intends to conduct the first stage of the trial at approximately 25 centres in the U.S., U.K., and Belgium but may elect to add centres in additional countries.

"Opening enrollment in our first pivotal study in an important step forward in our increasingly late stage REOLYSIN clinical program," said Dr. Brad Thompson, President and CEO of Oncolytics. "We expect enrollment to ramp up over the next quarter as additional centres come on line as the trial progresses."

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 will also receive, on a blinded basis, either intravenous placebo or
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SOURCE Oncolytics Biotech Inc.
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