Oncolytics Biotech Files Orphan Drug Designation With FDA For High Grade Gliomas

(RTTNews) - Oncolytics Biotech Inc. (ONC.TO, ONCY) has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration or FDA for REOLYSIN for the treatment of high grade gliomas or HGG in pediatric patients. Oncolytics has conducted three previous clinical trials in brain cancers including gliomas, and has found that REOLYSIN can infect a variety of brain tumors when delivered intravenously.

"High grade gliomas are typically a very aggressive form of cancer. They remain difficult to treat, particularly in pediatric patients, and are associated with poor survival outcomes," said Brad Thompson, President and CEO of Oncolytics. He added, "While surgical resection, radiotherapy and chemotherapy may be treatment options, REOLYSIN may offer these patients an alternative, more targeted therapeutic approach to treatment."

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.