Oncolytics Biotech Gets Orphan Drug Designation For Primary Peritoneal Cancer

(RTTNews) - Oncolytics Biotech Inc. (ONCY, ONC.TO) said that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation for its lead product candidate, Reolysin, for the treatment of primary peritoneal cancers.

The designation was granted on the basis of the company's December 2014 application for an Orphan Drug Designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication.

On February 11, 2015, the company said it had received Orphan Drug Designation for ovarian cancer and for cancers of the fallopian tube on March 2, 2015.

Dr. Brad Thompson, President and CEO of Oncolytics said, "This is the fourth indication for which we have received Orphan Drug Designation in the United States, and the third in a gynecological cancer indication. These Orphan Drug Designations are an important step for Oncolytics' ongoing program to develop and commercialize REOLYSIN® as a therapeutic for targeted cancer patient populations."

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.