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Translational Metastatic Colorectal Trial - United Kingdom

In January 2009, Oncolytics announced that patient enrolment had begun in a U.K. translational clinical trial investigating intravenous administration of REOLYSIN® in patients with metastatic colorectal cancer prior to surgical resection of liver metastases. The principal investigator is Professor Alan Melcher of St. James's University Hospital.

The trial (REO 013) is an open-label, non-randomized, single centre study of REOLYSIN® given intravenously to patients for five consecutive days in advance of their scheduled operations to remove colorectal cancer deposits metastatic to the liver. Patients will comprise two groups receiving REOLYSIN®, either at an early (21 to 10 days) or late time point (less than 10 days) before surgical resection. After surgery, the tumour and surrounding liver tissue will be assessed for viral status and anti-tumour effects.

The primary objectives of the trial are to assess the presence, replication and anti-cancer effects of reovirus within liver metastases after intravenous administration of REOLYSIN® by examination of the resected tumour. Secondary objectives include assessing the anti-tumour activity and safety profile of REOLYSIN®, and monitoring the humoral and cellular immune response to REOLYSIN®.

The University of Leeds is covering all costs of the trial, while Oncolytics will provide REOLYSIN®.

See related press releases and documents:

January 27, 2009 - Oncolytics Biotech Inc. Announces Start of Patient Enrolment in Translational Clinical Trial Investigating REOLYSIN® in Patients with Metastatic Colorectal Cancer