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US FDA grants orphan drug status to Oncolytics Biotech's Reolysin to treat gastric cancers

Thursday, May 7, 2015, 09:00 Hrs  [IST]

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) for Oncolytics Biotech's lead product candidate, Reolysin, for the treatment of gastric cancers.

"Oncolytics has assembled a portfolio of six indications where we have been granted Orphan Drug Designation by the FDA," said Dr Brad Thompson, president and CEO of Oncolytics. "We expect this will provide us with greater flexibility in the future development of Reolysin for these difficult to treat cancers."

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.

The American Cancer Society estimates that 24,590 Americans will be diagnosed with gastric (stomach) cancer and an estimated 10,720 Americans are expected to die from the disease in 2015. The relative five-year survival rate for all stages combined is approximately 28 per cent.

Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.  Oncolytics' clinical programme includes a variety of later-stage, randomized human trials in various indications using Reolysin, its proprietary formulation of the human reovirus.


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