Oncolytics gets U.K. approval for trial investigating Reolysin with radiation therapy

By E. Janene Geiss

Philadelphia, July 18 - Oncolytics Biotech Inc. said Tuesday that it has received a letter of approval from the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) for its Clinical Trial Application to begin a phase 2 clinical trial to evaluate the antitumor effects of intratumoral administration of Reolysin in combination with low-dose radiation in patients with advanced cancers.

Oncolytics said it will begin this trial based on promising safety and clinical responses observed in its phase 1a Reolysin/radiation trial, according to a company news release.

In the phase 1a trial, partial tumor responses were observed in a number of patients and the product was well-tolerated, officials said.

The trial is an open-label, single-arm, multi-center phase 2 study of Reolysin delivered via intratumoral injection to patients during treatment with low-dose radiotherapy.

Up to 40 evaluable patients, including about 20 patients with head and neck and esophageal cancers, and about 20 patients with other advanced cancers, will be treated with two intratumoral doses of Reolysin at 1x10(10) TCID(50) with a constant localized radiation dose of 20 Gy in five consecutive daily fractions.

Eligible patients include those who have been diagnosed with advanced or metastatic cancers including head, neck and esophageal tumors that are refractory to standard therapy or for which no curative standard therapy exists, officials said.

The primary objective of the trial is to assess the antitumor activity of the combination of Reolysin and low-dose radiotherapy in treated and untreated lesions.

Secondary objectives include the evaluation of viral replication, immune response to the virus and to determine the safety and tolerability of intratumoral administration of Reolysin in patients with advanced cancers who are receiving radiation treatment.

Oncolytics is a Calgary, Alta., biotechnology company focused on oncolytic viruses as cancer therapeutics.

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