Oncolytics Seeks Orphan Drug Status From FDA For REOLYSIN In Gastric Cancer

(RTTNews) - Oncolytics Biotech Inc. (ONC.TO, ONCY) Tuesday said it has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration for REOLYSIN for the treatment of gastric cancer.

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.

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.

"Patients diagnosed with later stage gastric cancer generally have very poor prognoses. As a result, gastric cancer is a serious issue both in the United States and other countries around the world including Japan and Korea where incidence rates are higher," said Dr. Brad Thompson, President and CEO of Oncolytics.