Oncolytics Biotech’s REOLYSIN receives Orphan Drug Designation for treatment of pancreatic cancer

Oncolytics Biotech^® Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN^®, for the treatment of pancreatic cancer.

"This is the second indication for which we have received Orphan Drug Designation in the United States," said Dr. Brad Thompson, President and CEO of Oncolytics. "The prognosis for pancreatic cancer is typically poor, and it is critical to expand the range of treatment options available to these patients."

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.

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. For more information, please visit: http://www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditions/default.htm.

The FDA has also granted an Orphan Drug Designation for the use of REOLYSIN^® for the treatment of ovarian cancer.