Oncolytics Biotech receives approval for UK clinical trial of of REOLYSIN

Oct 24 2007

Oncolytics Biotech Inc. has announced that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its Clinical Trial Application (CTA) to begin a clinical trial using intravenous administration of REOLYSIN in combination with cyclophosphamide, a chemotherapeutic agent as well as immune modulator, in patients with advanced cancers.

The Principal Investigators are Dr. James Spicer of King's College in London, Dr. Johann de Bono and Dr. Kevin Harrington of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, and Professor Hardev Pandha of the Royal Surrey County Hospital NHS Trust, Surrey and Mount Alvernia Hospitals.

The Company also intends to host a conference call Wednesday, October 24, 2007 to provide an update on its expanding clinical program. The dial-in details appear below.

“We are really looking forward to treating patients in this trial,” said Principal Investigator Dr. James Spicer. “The hope is that it will provide valuable information about the relationship between oncolytic viral therapy and the immune response of the patient.”

The trial (REO 012) is an open-label, dose-escalating, non-randomized trial of REOLYSIN® given intravenously with escalating doses of cyclophosphamide. A standard dose of REOLYSIN® is administered intravenously over five consecutive days, while an intravenous dose of cyclophosphamide is administered three days before REOLYSIN® treatment and continues through the course of the treatment cycle. The total number of patients studied will depend on the number of dose levels tested, but it is anticipated to be approximately 30 patients.