Oncolytics Gets Orphan Drug Designation From FDA For Cancer Of Fallopian Tube

(RTTNews) - Oncolytics Biotech Inc. (ONCY, ONC.TO) said Monday 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 cancer of the fallopian tube.

The designation was granted on the basis of the Company's December 2014 application for an Orphan Drug Designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication.

On February 11, 2015, the Company announced that it had received Orphan Drug Designation for ovarian cancer.

Oncolytics has supported two sponsored clinical studies assessing REOLYSIN® in the treatment of cancers of the fallopian tube. 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.