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Phase I Study (Complete) - Canada

A Phase I clinical trial of 18 terminal cancer patients with progressive (actively growing) cancers that had failed to respond to conventional treatments was performed. The study, conducted in Canada, examined the administration of escalating dosages of REOLYSIN® directly into a subcutaneous (underneath the skin) tumour. The primary objective of the study was to determine the safety (dose-limiting toxicity) and maximum tolerated dose of REOLYSIN®. Oncolytics announced final results of the study March 21, 2002. None of the patients receiving REOLYSIN® experienced any serious adverse events related to the virus, nor were there any dose limiting toxicities. Tumour responses were measured at both the treated lesion as well as remote tumour sites. Evidence of viral activity was detected in 11 of 18 patients (61%) with the tumour regression ranging from 32% to 100%. (Viral activity is defined as a transitory or lasting tumour regression of at least 30% measured in two dimensions against the tumour size prior to injection on the first day of treatment.)

The picture on the left was taken pretreatment and the picture on the right was taken post treatment. This was graded as a partial response.

(Squamous Unknown Primary)
Pre Treatment	Post Treatment
Best response at injected lesion, measured against baseline The waterfall graph above shows the percentage of tumour regression on a per patient basis at the lesion injected with REOLYSIN®, measured against baseline. *Bar graph is ordered by best response at injected lesion, starting from tumour regression of 100% as shown by first two bars on far left of graph. Results do not reflect the order in which patients were treated, or the dosage received.

See related news releases:

March 21, 2002 - Oncolytics Biotech Inc. Announces REOLYSIN® Phase I Clinical Trial Results -- Study indicates potential anti-cancer agent is safe for human use

December 13, 2001 - Oncolytics Biotech Inc. Announces REOLYSIN® Phase I Clinical Trial Interim Results