Oncolytics Biotech Inc. (ONCY) announced that it has submitted an application to FDA for obtaining orphan drug designation for Reolysin for the treatment of high-grade gliomas (HGG) in pediatric patients.
The U.S. Central Brain Tumor Registry estimates approximately 4,620 new cases of primary malignant and non-malignant brain and central nervous system tumors to be diagnosed in pediatric and adolescent patients in 2015. The total occurrence of HGG (including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma and malignant glioma) is approximately 0.8 in 100,000 patients from birth to 19 years of age.
In three clinical studies conducted by Oncolytic, it was found that Reolysin can impact a variety of brain tumors when delivered intravenously.
We note that the FDA grants orphan drug designation to candidates that are being developed to treat rare diseases/disorders that affect fewer than 200,000 people in the U.S. This status makes the candidate eligible for marketing exclusivity in the U.S., following approval. The designation will also make Oncolytics eligible for certain other benefits, including potential tax credits for certain activities, eligibility for orphan drug grants and the waiver of certain administrative fees.
Meanwhile, Oncolytics is also developing Reolysin for several other indications, including lung, colorectal and pancreatic cancers. Reolysin is Oncolytics’ lead candidate and hence we expect investor focus on further updates on the company’s pipeline.
Oncolytics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Biogen Idec (BIIB), Allergan (AGN) and Array Biopharmaceuticals, Inc. (ARRY). All three carry a Zacks Rank #2 (Buy).
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