Positive results from Oncolytics' combination REOLYSIN-docetaxel Phase I trial in advanced cancer

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) announced today that a paper entitled "REO-10: A Phase I Study of Intravenous Reovirus and Docetaxel in Patients with Advanced Cancer," was recently published by Comins et al in the journal Clinical Cancer Research (Clin Cancer Res 16(22):5564-5572).

The paper reports final results from a combination REOLYSIN and docetaxel trial, (REO 010) designed to evaluate the anti-tumour effects of systemic administration of REOLYSIN in combination with docetaxel (Taxotere^®) in patients with advanced cancers. Patients received docetaxel on day one (75mg/m²) and escalating doses of reovirus up to 3 x 10¹⁰ TCID₅₀ on days one through five, every three weeks. The principal investigator was Professor Hardev Pandha of the Royal Surrey County Hospital, U.K.

Twenty-five patients were enrolled, with 24 being exposed to treatment and 23 completing at least one cycle of therapy. Sixteen patients were suitable for response assessment. The combination was deemed to be safe and well tolerated and a maximum tolerated dose was not reached. Antitumour activity was seen with one complete response (in the liver of a breast cancer patient with no evidence of disease recurrence at the end of the study, following eight cycles of treatment) and three partial responses. A disease control rate (combined complete response, partial response and stable disease) of 88% was observed. The authors concluded that the combination of reovirus and docetaxel is safe, with evidence of objective disease response, and warrants further evaluation in a Phase II study at a recommended schedule of docetaxel (75mg/m², three times weekly) and reovirus (3 x 10¹⁰ TCID₅₀, days one to five, every three weeks).

Eligible patients included those who had been diagnosed with advanced or metastatic solid tumours including bladder, lung, prostate or upper gastro-intestinal cancers that were refractory (had not responded) to standard therapy or for which no curative standard therapy existed. The primary objective of the trial was to determine the MTD, Dose-Limiting Toxicity, recommended dose and dosing schedule and safety profile of REOLYSIN when administered in combination with docetaxel. Secondary objectives included the evaluation of immune response to the drug combination, the body's response to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.

"These findings demonstrate a clear benefit for patients, even at lower doses, and provide us with additional patient data on another REOLYSIN/chemotherapy combination that we may elect to advance into later stage testing in the future," said Dr. Brad Thompson, President and CEO of Oncolytics.