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Phase I Systemic Delivery Trial - United States

In June 2009, Oncolytics announced positive results from its Phase I clinical trial to investigate the systemic delivery of REOLYSIN® as a treatment for patients with advanced or metastatic solid tumours. Of the 18 patients treated, eight demonstrated stable disease as measured by RECIST (Response Evaluation Criteria in Solid Tumours) including a patient with progressive breast cancer who experienced a 34% shrinkage in tumour volume.

The primary objective of the study was to determine the maximum tolerated dose, dose limiting toxicity and safety profile of REOLYSIN®. Secondary objectives included the evaluation of viral replication, immune response to the virus and any evidence of antitumour activity.

See related press releases:

Dose escalation and pharmacodynamic study of IV REOLYSIN®, a proprietary formulation of a live replication competent RNA virus in patients with advanced solid tumors

June 1, 2009 - Oncolytics Biotech® Inc. Collaborators Present Positive Phase II Sarcoma Trial Results at ASCO Annual Meeting

June 5, 2007 - Oncolytics Biotech Inc. Announces Positive Clinical Data from U.S. Phase I REOLYSIN® Trial

August 23, 2006 - Oncolytics Biotech Inc. Completes Patient Enrolment in U.S. Phase I Systemic Administration Clinical Trial

September 28, 2005 - Oncolytics Biotech Inc. Begins Patient Enrolment in U.S. Systemic Delivery Clinical Trial

April 7, 2005 - Oncolytics Biotech Inc. Receives FDA Clearance to Initiate Phase I Systemic Delivery Clinical Trial