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Oncolytics completes enrollment in phase 1a combination Reolysin/radiation trial
By E. Janene Geiss
Philadelphia, June 20 - Oncolytics Biotech Inc. announced Tuesday that it has completed patient enrollment in its phase 1a U.K. clinical trial investigating the use of Reolysin in combination with radiation to treat patients with advanced cancers.
A total of 11 patients were treated in the phase 1a trial with two intratumoral treatments of Reolysin at dosages of 1x10(8), 1x10(9), or 1x10(10) TCID(50) with a constant localized radiation dose of 20 Gy in five fractions, according to a company news release.
A maximum-tolerated dose was not reached and the combination treatment appears to have been well-tolerated by the patients.
Interim results recently were presented at the American Association for Cancer Research meeting in Washington, D.C. Preliminary analysis demonstrated evidence of local and systemic response, officials said.
The phase 1b portion of the trial, which will immediately follow the phase 1a portion, will treat patients with a range of two to six intratumoral doses of Reolysin at 1x10(10) TCID(50) with a constant radiation dose of 36 Gy in 12 fractions.
The primary objective of the trial is to determine the maximum-tolerated dose, 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, officials said.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumors that have not responded to standard therapy or for which no curative standard therapy exists.
Oncolytics is a Calgary, Alta., biotechnology company focused developing oncolytic viruses as cancer therapeutics.
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