Oncolytics complete patient enrollment in Study II in metastatic pancreatic cancer Phase

Oncolytics complete patient enrollment in Study II in metastatic pancreatic cancer Phase -

Oncolytics Biotech Inc. ( "Oncolytics") (TSX: ONC, NASDAQ: ONCY) announced today the completion of patient enrollment in a study carboplatin, paclitaxel plus REOLYSIN ^® against carboplatin and paclitaxel alone in the first-line treatment of patients recurrent or metastatic cancer of the pancreas (OSU-10045) in two randomized phase II arm. The principal investigator is Tanios Bekaii-Saab, MD, associate professor and chief of gastrointestinal oncology section of the Comprehensive Cancer Center at Ohio State University - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC of - James) . The trial is sponsored by the National Cancer Institute of the USA (NCI) through an agreement on clinical trials between the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis and Oncolytics. Oncolytics provide clinical supplies of REOLYSIN for the study.

"This is the second randomized trial using REOLYSIN to complete registration," said Dr. Brad Thompson, President and CEO of Oncolytics. "This study is important given the relatively limited treatment options and generally a poor prognosis for patients with pancreatic cancer, which often are not diagnosed until the later stages of the disease."

the study is an open-label, multi-institution, phase II two-arm randomized study of patients with metastatic pancreatic cancer. patients were randomized to receive either carboplatin, paclitaxel plus REOLYSIN ( arm a) or carboplatin and paclitaxel alone (arm B). patients in both arms received treatment every three weeks (21 day cycles) and standard intravenous doses of paclitaxel and carboplatin on day one only. in arm a, the patients also received intravenous REOLYSIN at a dose of 3x10 ¹⁰ TCID ₅₀ the one to five days. assessment of tumor response was performed by CT (TDM) and conducted every eight weeks. Patients who progress on carboplatin and paclitaxel (Arm B) had added REOLYSIN. If patients have significant toxicity related to carboplatin and / or paclitaxel they may continue with single agent REOLYSIN.

The primary objective of the trial is to evaluate the improvement of progression-free survival with REOLYSIN, carboplatin and paclitaxel versus carboplatin and paclitaxel alone in patients with pancreatic cancer metastatic. The primary endpoint is progression-free survival in both arms. Secondary endpoints include overall response rate and overall survival. The study included 70 evaluable patients in test centers across the United States.

As a sponsor of the study, the NCI is responsible for tracking patients and collect and compile all patient data. Once completed, the data will be analyzed and provided for Oncolytics.

Bekaii-Saab, principal investigator of the clinical study, has no financial interest in Oncolytics, REOLYSIN the manufacturer of the investigational product.