Oncolytics Files For Orphan Drug Designation For Pancreatic & Ovarian Cancers

(RTTNews) - Oncolytics Biotech Inc. (ONCY, ONC.TO) has submitted applications for Orphan Drug Designation to the U.S. Food and Drug Administration or FDA for REOLYSIN to treat pancreatic and ovarian cancers.

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.

REOLYSIN is Oncolytics' proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.