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news.Canadian biotechnology firm Oncolytics Biotech has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its lead product candidate, Reolysin, to treat malignant glioma.
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An ODD has been applied by the company for pediatric high grade gliomas (HGG), however the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages.
In three previous brain cancer trials including gliomas, Reolysin has been shown to infect a variety of brain tumors when delivered intravenously.
Oncolytics president and CEO Dr Brad Thompson said: "The focus of our Orphan Drug submissions has been on difficult to treat cancers where patients have few effective treatment options.
"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."
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 US (CBTRUS).