Oncolytics's Reolysin receives orphan drug designationIt is totally beyond me why the s/p is trading at these incredibly low level....Something must give eventually on the upside.....GLTA
Oncolytics's Reolysin receives orphan drug designation
2015-04-17 07:10 ET - News Release
Dr. Brad Thompson reports
ONCOLYTICS BIOTECHATRADEMARK INC. ANNOUNCES RECEIPT OF ORPHAN DRUG DESIGNATION FROM THE U.S. FDA FOR MALIGNANT GLIOMAS
The United States Food and Drug Administration has granted an orphan drug designation for Oncolytics Biotech Inc.'s lead product candidate, Reolysin, for the treatment of malignant glioma. The company applied for an ODD for pediatric high-grade gliomas; however, the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages. In three previous brain cancer studies including gliomas, Reolysin has been shown to infect a variety of brain tumours when delivered intravenously.
"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 chief executive officer 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."
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.
According to the Central Brain Tumor Registry of the United States, in 2015, an estimated 68,470 new cases of primary malignant and non-malignant brain and central nervous system tumours will be diagnosed, of which 23,180 estimated new cases will be primary malignant tumours and 4,620 estimated new cases will be diagnosed in pediatric and adolescent patients. The CBTRUS estimates that the broad category glioma represents approximately 80 per cent of malignant tumours, and in patients between zero and 19 years of age, the overall total incidence of HGG (including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma and malignant glioma) is approximately 0.8 per 100,000.
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