Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) today announced completion of patient enrollment in a two-arm randomized phase II study of carboplatin, paclitaxel plus REOLYSIN® versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer (OSU-10045). The principal investigator is Tanios Bekaii-Saab, MD, associate professor and gastrointestinal oncology section chief at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James). The trial is sponsored by the U.S. National Cancer Institute (NCI) through a clinical trials agreement between the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis and Oncolytics. Oncolytics is providing clinical supplies of REOLYSIN for the study.
"This is the second randomized study utilizing REOLYSIN to complete enrollment," said Dr. Brad Thompson, President and CEO of Oncolytics. "This is an important study given the relatively limited treatment options and generally poor prognosis for pancreatic cancer patients, who are often not diagnosed until the more advanced stages of the disease."
The study is an open-label, multi-institution, two-arm phase II 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, patients also received intravenous REOLYSIN at a dose of 3x1010 TCID50 on days one through five. Tumor response assessment was done by computed tomography (CT) scan and conducted every eight weeks. Patients who progressed on carboplatin and paclitaxel (Arm B) had REOLYSIN added. If patients experienced significant toxicity related to carboplatin and/or paclitaxel, they could continue with single agent REOLYSIN.
The primary objective of the trial is to assess improvement in progression-free survival with REOLYSIN, carboplatin and paclitaxel relative to carboplatin and paclitaxel alone in patients with metastatic pancreatic cancer. The primary endpoint is progression free survival in both arms. Secondary endpoints include overall response rate and overall survival. The study enrolled 70 evaluable patients at test centers across the United States.
As the sponsor of the study, the NCI is responsible for following patients and collecting and collating all patient data. Once complete, the data will be analyzed and provided to Oncolytics.
Bekaii-Saab, principal investigator of the clinical study, has no financial interests in Oncolytics, manufacturer of the investigational drug REOLYSIN.