Oncolytics Biotech submits Orphan Drug Designation for pancreatic, ovarian cancers

Dec 2 2014

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) today announced that it has submitted applications for Orphan Drug Designation to the U.S. Food and Drug Administration ("FDA") for REOLYSIN^® for the treatment of pancreatic and ovarian cancers.

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.

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.

"Many patients with either pancreatic or ovarian cancer are not diagnosed until after their disease has progressed to its later stages, which reduces their survival outcomes," said Dr. Brad Thompson, President and CEO of Oncolytics. "The development of more targeted treatment options, in this case an agent targeting cancers with Ras pathway defects, will allow patients to access the most suitable treatment for their specific case."