FDAnews
www.fdanews.com/articles/88226-oncolytics-begins-enrolment-in-phase-ib-trial-of-anti-tumor-therapy

ONCOLYTICS BEGINS ENROLMENT IN PHASE IB TRIAL OF ANTI-TUMOR THERAPY

July 10, 2006

Oncolytics Biotech has announced that it has commenced patient enrolment in its Phase Ib UK clinical trial investigating REOLYSIN in combination with radiation therapy as a treatment for patients with advanced cancers. The Phase Ib 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.

The primary objective of the Phase Ib 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 anti-tumor activity. Eligible patients include those 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. An additional group of patients will at the maximum dose regimen reached in the Ib trial.