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Oncolytics begins enrollment in U.K. phase 1b trial of Reolysin for advanced cancers
By E. Janene Geiss
Philadelphia, July 10 - Oncolytics Biotech Inc. said Monday that it has begun patient enrollment in its phase 1b U.K. clinical trial investigating Reolysin in combination with radiation therapy as a treatment for patients with advanced cancers.
The trial 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, according to a company news release.
Patient enrollment in the 1a combination Reolysin/radiation trial was completed in June.
The phase 1a trial tested 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 given in five fractions.
A maximum tolerated dose was not reached and the combination treatment appears to have been well-tolerated by the patients, officials said.
Interim results of the 1a trial were presented in April at the American Association for Cancer Research annual meeting.
Preliminary analysis has demonstrated evidence of both local and systemic response, officials said.
The primary objective of the phase 1b 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 are refractory to standard therapy or for which no curative standard therapy exists.
An additional group of patients is planned to be treated at the maximum-dose regimen reached in the 1b trial, officials said.
Oncolytics is a Calgary, Alta., biotechnology company focused on oncolytic viruses as cancer therapeutics.
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