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www.fdanews.com/articles/81247-oncolytics-biotech-begins-patient-enrollment-in-reolysin-trial

ONCOLYTICS BIOTECH BEGINS PATIENT ENROLLMENT IN REOLYSIN TRIAL

September 28, 2005

Oncolytics Biotech has started patient enrollment in a clinical trial investigating the systemic delivery of Reolysin as a treatment for patients with advanced or metastatic solid tumors.

This clinical trial is an open-label, dose-escalation Phase I study in which a single dose of Reolysin will be administered intravenously to patients diagnosed with selected advanced or metastatic solid tumors that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The enrollment in this study is expected to be up to thirty-six evaluable patients and will depend in part upon the number of dose levels tested. The primary objective of the study is to determine the maximum tolerated dose, dose limiting toxicity and safety profile of Reolysin. Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of antitumor activity.