Oncolytics Reolysin study shows 88% disease control
2010-11-29 06:50 MT - News Release
Dr. Brad Thompson reports
ONCOLYTICS BIOTECH INC. ANNOUNCES PUBLICATION OF PHASE I CLINICAL TRIAL RESULTS EXAMINING COMBINATION OF REOLYSIN AND DOCETAXEL IN CLINICAL CANCER RESEARCH
Oncolytics Biotech Inc. has received notice 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 the first day (75 milligrams per square metre) and escalating doses of reovirus up to three times 1,010 TCID50 on days one through five, every three weeks. The principal investigator was Prof. Hardev Pandha of the Royal Surrey County Hospital in the United Kingdom.
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. Anti-tumour 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 per cent 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 2 study at a recommended schedule of docetaxel (75 milligrams per square metre, three times weekly) and reovirus (three times 1,010 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 gastrointestinal 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 with 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 chief executive officer of Oncolytics.
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