The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for Oncolytics Biotech’s proprietary formulation of the human reovirus (Reolysin) for the treatment of ovarian and pancreatic cancer. The reovirus’s primary mode of activity is to infect and selectively target tumors with activating Ras pathway mutations and/or overexpressions of Ras pathway elements including EGFR, BRAF, and KRAS.
Oncolytics has supported two sponsored clinical studies assessing the reovirus in the treatment of ovarian cancer. The first was a phase I/II clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal, and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of the human reovirus that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells.
The second study is an ongoing randomized phase II trial (GOG186H) of weekly paclitaxel vs weekly paclitaxel with the reovirus in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014. ■