FDA Grants Orphan Drug Designation To Oncolytics' Reolysin For Ovarian Cancer

(RTTNews) - Oncolytics Biotech Inc. (ONC.TO, ONCY) said that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation for its lead product candidate, Reolysin, for the treatment of ovarian cancer.

Oncolytics noted that it 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.

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the U.S. at any given time.