COG to conduct Phase I REOLYSIN trial in pediatric patients with solid tumors

Nov 19 2010

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) announced today that the Children's Oncology Group (COG) intends to conduct a Phase I trial of REOLYSIN^® in combination with cyclophosphamide in pediatric patients with relapsed or refractory solid tumors. The study will be conducted in collaboration with the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, under its Clinical Trials Agreement with Oncolytics. Oncolytics will provide clinical supplies of REOLYSIN for this study. The study chair will be Dr. E. Anders Kolb of the Nemours/Alfred I. duPont Hospital for Children.

The study is an open label, multicentre, dose escalation Phase I study of REOLYSIN in patients aged three to 21 years with relapsed or refractory solid tumors. Patients will receive intravenous REOLYSIN on days one through five of each 28-day treatment cycle. Some patients will also receive oral cyclophosphamide on days one through 21. Treatments repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

The primary objectives of the trial include estimating maximum tolerated dose, and defining and describing the toxicities of REOLYSIN and REOLYSIN plus oral cyclophosphamide in this patient population. Secondary objectives include defining antitumor activity of REOLYSIN within the confines of a Phase I study, evaluating the development of neutralizing antibodies to REOLYSIN following intravenous administration of REOLYSIN alone and in combination with cyclophosphamide, and assessing the biologic activity of REOLYSIN. After completion of study treatment, patients are to be followed up periodically for up to one year.

"This trial builds on a range of completed preclinical work and clinical studies in adult patients, including a U.K. Phase I clinical study examining the use of REOLYSIN in conjunction with cyclophosphamide and a U.S. Phase II clinical study in sarcoma using REOLYSIN as a monotherapy," said Dr. Brad Thompson, President and CEO of Oncolytics. "It is very important to investigate the use of an agent in adults prior to proceeding to use in pediatric patients. With the work in adults well advanced, we can now move ahead in younger patients."

Information on the study will be available at www.clinicaltrials.gov.