Oncolytics Gets Approval for UK Trial of Reolysin, Radiation Therapy

Oncolytics Biotech has received a letter of approval from the UK Medicines and Healthcare products Regulatory Agency for its clinical trial application to begin a Phase I clinical trial to evaluate the feasibility, safety and antitumor effects of intratumoral administration of Reolysin in combination with radiation in patients with advanced cancers.

The trial is a Phase I, open-label, dose-escalation study of Reolysin combined with two different radiation dosages/schedules. The enrollment in this study is expected to be approximately 30 evaluable patients, and will depend upon the number of dose levels tested. Up to an additional 15 patients will also be treated at the maximum-tolerated dose (MTD).

The primary objective of the study is to determine the MTD, dose-limiting toxicity and safety profile of Reolysin when administered intratumorally to patients receiving radiation treatment. A secondary objective is to examine any evidence of antitumor activity. Patients who have been diagnosed with advanced or metastatic solid tumors that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists will be eligible.