Oncolytics completes Phase II trial enrollment for REOLYSIN in prostate cancer

Oct 6 2015

Oncolytics Biotech^® Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) today announced that enrollment has been completed in a randomized Phase II study of REOLYSIN^® in patients with recurrent or metastatic castration resistant prostate cancer (IND 209). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario.

"Prostate cancer remains a leading cause of cancer-related death in men," said Dr. Brad Thompson, President and CEO of Oncolytics. "As a result, it is important that we continue to conduct studies with late-stage patients to help improve outcomes for this group."

The study is an open-label, randomized, non-blinded, Phase II clinical study of REOLYSIN^® given in combination with docetaxel versus docetaxel alone. Approximately 40 response evaluable patients were enrolled in each arm.

The primary objective of the trial is to evaluate the efficacy of REOLYSIN^® in combination with docetaxel based on the lack of disease progression as measured at 12 weeks. Secondary objectives are to determine circulating tumour cell status at six and 12 weeks and the conversion rate of these cells, prostate-specific antigen (PSA) change rate, objective response rate (in patients with measurable disease at baseline), effect on overall survival, the tolerability and toxicity of the treatment combination, and to explore potential molecular factors predictive of response.

Although accrual is complete, patient follow-up will continue until planned analyses have been conducted.