Oncolytics Biotech Inc. has commenced patient enrolment in its UK clinical trial to evaluate the anti-tumour effects of systemic administration of Reolysin in combination with docetaxel (Taxotere) in patients with advanced cancers including bladder, prostate, lung and upper gastro-intestinal. In preclinical studies, the combination of Reolysin and various taxanes including docetaxel has been shown to be synergistic against a variety of cancer cell lines.
"Taxanes are widely used in the treatment of cancer but have the potential to be significantly more efficacious when used with Reolysin, which has already shown anti-tumour activity on its own," said Dr Brad Thompson, President and CEO of Oncolytics. "This is the third in a series of clinical trials assessing Reolysin in combination with current, widely used chemotherapeutic agents. Commencing enrolment in this trial is another significant step forward in the development of Reolysin as a cancer therapeutic."
The principal investigator is Professor Hardev Pandha of St. Lukes Cancer Centre, Royal Surrey County Hospital, Guildford, UK.
The trial (REO 010) has two components. The first is an open-label, dose-escalating, non-randomised study of Reolysin given intravenously with docetaxel every three weeks. A standard dosage of docetaxel will be delivered with escalating dosages of Reolysin intravenously. A maximum of three cohorts will be enrolled in the Reolysin dose escalation portion. The second component of the trial will immediately follow and will include the enrolment of a further 12 patients at the maximum dosage of Reolysin in combination with a standard dosage of docetaxel.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours such as bladder, prostate, lung or upper gastro-intestinal cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The primary objective of the trial is to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety profile of Reolysin when administered in combination with docetaxel. Secondary objectives include 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. This is the third trial beginning in 2007 that is examining the role of Reolysin in combination with standard chemotherapeutics.