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Phase II Combination REOLYSIN®/Radiation Therapy Trial - United Kingdom In April 2009, Oncolytics announced results of its Phase II clinical trial investigating the anti-tumour effects of intratumoural administration of REOLYSIN® in combination with low-dose radiation in patients with advanced cancers. A total of 16 heavily pretreated patients with advanced cancer (melanoma (5), colorectal (4), gastric (1), pancreas (1), ovarian (1), lung (1), cholangiocarcinoma (1) sinus (1), and thyroid (1)) were enrolled in the trial. Most patients had received prior chemotherapy (13 patients) or radiation (5 patients). Of 14 patients evaluable for response, 13 patients had stable disease (SD) or better in the treated target lesions. Of these, partial responses (PR) were observed in four patients (lung, melanoma (2) and gastric) and minor responses were observed in two patients (thyroid, ovarian), for a total disease control rate (stable disease + partial response + complete response) of 93% in the treated lesions. The combination was well tolerated, with only mild (Grade 1 or 2) toxicities noted. The trial is an open-label, single-arm, multi-centre Phase II study of REOLYSIN® delivered via intratumoural injection to patients during treatment with low-dose radiotherapy. The primary objective of the trial is to assess the anti-tumour activity of the combination of REOLYSIN® and low dose radiotherapy in treated and untreated lesions. Secondary objectives include the evaluation of viral replication, immune response to the virus and to determine the safety and tolerability of intratumoural administration of REOLYSIN® in patients with advanced cancers who are receiving radiation treatment. See related press releases and documents: April 7, 2009 - Oncolytics Biotech® Inc. Announces Positive Results of U.K. Phase II REOLYSIN® and Radiation Combination Clinical Trial December 18, 2008 - Oncolytics Biotech Inc. Completes Patient Enrolment in Two U.K. REOLYSIN® Combination Therapy Clinical Trials --Company to Host Conference Call to Update Clinical Program December 22, 2006 - Oncolytics Biotech Inc. Starts Patient Enrolment in U.K. Phase II Clinical Trial July 18, 2005 - Oncolytics Biotech Inc. Announces Approval for Phase II U.K. Clinical Trial Investigating REOLYSIN® in Combination with Radiation Therapy |
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