On February 11, 2015 Oncolytics Biotech reported 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 (Press release Oncolytics Biotech, FEB 11, 2015, View Source [SID:1234501535]).
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"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 Dr. Brad Thompson, President and CEO of Oncolytics. "Ovarian cancer is a devastating disease that represents a significant unmet need, particularly for those patients diagnosed in later stages."
Oncolytics 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 United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.