GOG to conduct Phase II trial on primary peritoneal cancer

Sep 3 2010

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) announced today that the Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN(R) in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer (GOG186H). The study has been approved and will be sponsored by 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. David E. Cohn of The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

"Ovarian cancer is typically diagnosed at the later stages, because earlier stage disease usually has no obvious symptoms," said Dr. David E. Cohn. "On this basis, surgical interventions used in earlier stages are often supplemented by chemotherapy; however, there are limited treatment options for patients with recurrent disease."

The study is a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized to receive either paclitaxel alone or paclitaxel plus REOLYSIN. Patients in both arms will receive treatment with paclitaxel, with the second arm also receiving intravenous REOLYSIN. Patients will receive standard doses of paclitaxel on days one, eight, and 15 every 28 days. In the second arm, patients will also receive, on days one through five of each 28-day cycle, intravenous REOLYSIN at a dose of 3x1010 TCID50.

The primary objectives of the trial are to estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel with REOLYSIN to weekly paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer and to determine the frequency and severity of adverse events associated with treatment with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN as assessed by Common Terminology Criteria for Adverse Events (CTCAE). The secondary objectives are to estimate the progression-free survival and overall survival of patients treated with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN; to estimate (and compare) the proportion of patients who respond to the regimen on each arm of the study (according to RECIST 1.1 with measurable patients and by CA-125 for those patients with detectable disease only); and to characterize and compare progression-free survival and overall survival in patients with measurable disease (RECIST 1.1 criteria) and patients with detectable (nonmeasurable) disease. The study is expected to enroll up to 150 patients.

"Oncolytics is pleased to be collaborating with the NCI and GOG as they push forward innovative research initiatives utilizing REOLYSIN," said Dr. Brad Thompson, President and CEO of Oncolytics. "Relationships with these groups allow us to broaden our clinical program to include additional indications and, in this case, conduct our first randomized Phase II study."

SOURCE Oncolytics Biotech Inc.