Oncolytics' REOLYSIN receives FDA Orphan Drug Designation for treatment of ovarian cancer

Oncolytics Biotech^® Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN^®, for the treatment of ovarian cancer.

"This is an important regulatory milestone for Oncolytics and will provide us with a number of benefits as we advance the development and commercialization process for REOLYSIN^®," said Dr. Brad Thompson, President and CEO of Oncolytics. "Ovarian cancer is a devastating disease that represents a significant unmet need, particularly for those patients diagnosed in later stages."

Oncolytics has supported two sponsored clinical studies assessing REOLYSIN^® in the treatment of ovarian cancer. The first was a Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of REOLYSIN^® that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with REOLYSIN^® in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014.