US health regulators granted orphan drug designation to Calgary-based Oncolytics Biotech’s lead brain tumor candidate.
The company announced that the US Food and Drug Administration (FDA) granted orphan status to its Reolysin for treatment of malignant glioma. Oncolytics said that it had applied for orphan designation for pediatric high grade gliomas (HGG), however the agency granted the designation for the broader of malignant glioma in patients of all ages. Among the benefits associated with orphan drug status is a seven-year period of marketing exclusivity for the indication if approved by the agency.
“The focus of our Orphan Drug submissions has been on difficult to treat cancers where patients have few effective treatment options,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Pediatric patients with high grade gliomas have particularly poor expected outcomes. We believe these patients, along with the adult population affected by malignant gliomas, would benefit from having additional treatment options.”
According to the company, in three previous brain cancer studies including gliomas, Reolysin has shown to infect a variety of brain tumors when administered intravenously.
In 2015, an estimated 68,470 new cases of primary malignant and non-malignant brain and central nervous system tumors will be diagnosed, of which 23,180 estimated new cases will be primary malignant tumors and 4,620 estimated new cases will be diagnosed in pediatric and adolescent patients, according to the Central Brain Tumor Registry of the United States (CBTRUS). The CBTRUS estimates that the broad category glioma represents approximately 80 percent of malignant tumors and in patients between zero and 19 years of age, the overall total incidence of HGG is approximately 0.8 per 100,000.
Reolysin is a proprietary variant of the reovirus, which most people have been exposed to by adulthood. The reovirus is non-pathogenic, meaning that infections are typically asymptomatic. Oncolytics’ Chief Operating Officer, Dr. Matt Coffey’s research is the basis of Reolysin. It was found that the reovirus was able to infect and selectively destroy cancer cells. In normal cells infected with reovirus, an antiviral response is activated preventing the virus from replicating within the cell. However, inside a cancer cell with one or more mutations on the Ras pathway, a growth pathway, there is an aberrant antiviral response that is unable to prevent the virus from replicating, allowing the reovirus to multiply to an extent that is fatal to the cancer cell.
Source: Oncolytics Biotech, Inc.
Last updated: 4/17/15; 2:45pm EST