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news.Oncolytics Biotech has submitted applications for Orphan Designation to the European Medicines Agency for REOLYSIN for the treatment of pancreatic and ovarian cancers.
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"This is the second jurisdiction in which we have elected to file for Orphan Designation," said Dr. Brad Thompson , President and CEO of Oncolytics. "The EMA serves all 28 member countries of the EU and securing Orphan Designation would help support the future development of REOLYSIN in the region."
The EMA grants Orphan Designation to medicines intended to treat, prevent or diagnose life threatening and debilitating disease, with a prevalence no greater than five in 10,000 in the EU, and where no satisfactory method of treatment, prevention or diagnosis exists, unless the proposed medicine offers a significant benefit to those with the condition.
Following Orphan Designation, sponsors can access a number of incentives including protocol assistance, market exclusivity for a ten-year period following approval and potential fee reductions. The receipt of Orphan Designation does not change the regulatory requirements or process for obtaining marketing approval.
REOLYSIN is Oncolytics’ proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.
Pancreatic cancer affects approximately 45,300 patients at any given time in the European Union and has a prevalence of approximately 0.88 per 10,000.
Ovarian cancer affects approximately 150,000 women at any given time in the European Union and has a prevalence of approximately 3 per 10,000.
Oncolytics is a Calgary -based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN, its proprietary formulation of the human reovirus.