Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) 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 high grade gliomas (HGG) in pediatric patients. Oncolytics has conducted three previous clinical studies 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 Dr. Brad Thompson, President and CEO of Oncolytics. "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. 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.
According to the US Central Brain Tumor Registry an estimated 4,620 new cases of primary malignant and non-malignant brain and central nervous system tumors will be diagnosed in pediatric and adolescent patients in 2015. In patients between zero and 19 years old, the overall total incidence of HGG (including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma, and malignant glioma) is approximately 0.8 per 100,000.