FDA Grants Orphan Drug Designation to Human Reovirus Formulation for the Treatment of Ovarian Cancer
Oncolytics Biotech, Inc, a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its proprietary formulation of the human reovirus (Reolysin) for the treatment of ovarian cancer.
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 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.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
