Oncolytics Biotech announced that 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, has agreed to sponsor a 2-Arm randomized Phase 2 study of carboplatin, paclitaxel plus Reolysin versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer. The study is an open-label, multi-institution, 2-arm randomized study of about 70 patients with metastatic pancreatic cancer. Patients will be randomized to receive carboplatin, paclitaxel plus Reolysin (Arm A) or carboplatin and paclitaxel alone (Arm B).
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.
Reolysin is a formulation of the human reovirus designed to replicate specifically in tumor cells bearing an activated Ras pathway. Activating mutations of Ras and upstream elements of Ras may play a role in greater than two thirds of all human cancers.
For more information call (403) 670-7377 or visit www.oncolyticsbiotech.com.