From the website.
10/23/2007
5:13:16 PM ET
Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN® in Combination with Cyclophosphamide
CALGARY, AB, --- October 23, 2007 -
Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today 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.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours including pancreatic, lung and ovarian cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.
The primary objectives of the trial include determining the Minimum Effective Immunomodulatory Dose (MED) of cyclophosphamide to obtain successful immune modulation. Secondary objectives include the safety profile of the combination and gathering any evidence of anti-tumour activity.
Conference Call Details
Oncolytics will host a conference call at 2:00 p.m. EST on Wednesday, October 24, 2007, to provide a general update on its ongoing clinical trial program.
To access the conference call by telephone, dial 1-416-644-3414 or 1-800-731-5319. A live audio webcast will be available at: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2054580 or through the Company’s website at http://www.oncolyticsbiotech.com/.
Please connect at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through October 31, 2007. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation number 21251367#.
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