Oncolytics Biotech Inc. Announces Filing for Orphan Drug Designation with the U.S. FDA for Gastric Cancer

Oncolytics Biotech® Inc. ("Oncolytics")

today announced that it has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration ("FDA") for REOLYSIN® for the treatment of gastric cancer. "Patients diagnosed with later stage gastric cancer generally have very poor prognoses," said Dr. Brad Thompson, President and CEO of Oncolytics. "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." 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 American Cancer Society estimates that 24,590 Americans will be diagnosed with gastric (stomach) cancer and an estimated 10,720 Americans are expected to die from the disease in 2015. The relative five-year survival rate for all stages combined is approximately 28 percent.