Oncolytics Biotech Inc., a Calgary-based biotechnology company, has completed patient enrolment in its phase Ia UK clinical trial investigating the use of Reolysin in combination with radiation to treat patients with advanced cancers, a company release stated.

A total of 11 patients were treated in the phase Ia trial with two intratumoural treatments of Reolysin at dosages of 1x10(8), 1x10(9), or 1x10(10) TCID50 with a constant localized radiation dose of 20 Gy in five fractions. A maximum tolerated dose (MTD) was not reached and the combination treatment appears to have been well tolerated by the patients.

Interim results of the trial were presented at the American Association for Cancer Research (AACR) Annual Meeting in Washington, D.C. in April 2006. Preliminary analysis has demonstrated evidence of local and systemic response.

The phase Ib portion of the trial, which will immediately follow the phase Ia portion, will treat patients with a range of two to six intratumoural doses of Reolysin at 1x10(10) TCID50 with a constant radiation dose of 36 Gy in 12 fractions.

The primary objective of the trial is to determine the MTD, dose limiting toxicity (DLT), and safety profile of Reolysin when administered intratumourally to patients receiving radiation treatment. A secondary objective is to examine any evidence of anti-tumour activity. Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.

The principal investigators for the trial are Dr. Kevin Harrington of the Targeted Therapy Laboratory, The Institute of Cancer Research, Cancer Research UK Centre for Cell and Molecular Biology and Honorary Consultant in Clinical Oncology at The Royal Marsden NHS Foundation Trust, London, UK, and Dr. Alan Melcher of the Cancer Research U.K. Clinical Centre at St. James's University Hospital in Leeds. The trial is enrolling patients at the Royal Marsden and St. James's Hospitals in the UK.