FDA Grants Orphan Drug Designation For Oncolytics' REOLYSIN For Ovarian Cancer

(RTTNews) - Oncolytics Biotech Inc. (ONC.TO, ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, 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 Brad Thompson, President and CEO of Oncolytics.

Oncolytics has supported two sponsored clinical studies evaluating REOLYSIN in the treatment of ovarian cancer. The first was a Phase 1/2 study 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 of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial concluded enrollment in September 2014.