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Oncolytics seeks FDA orphan drug status for REOLYSIN to treat pancreatic and ovarian cancers

Oncolytics Biotech has submitted applications to the US Food and Drug Administration (FDA) seeking orphan drug designation for its proprietary isolate of the reovirus, REOLYSIN to treat pancreatic and ovarian cancers.

REOLYSIN’s 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.

The company said that about 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.

Oncolytics president and CEO Dr Brad Thompson said: "Many patients with either pancreatic or ovarian cancer are not diagnosed until after their disease has progressed to its later stages, which reduces their survival outcomes.

"The development of more targeted treatment options, in this case an agent targeting cancers with Ras pathway defects, will allow patients to access the most suitable treatment for their specific case."

The company’s clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN, its proprietary formulation of the human reovirus.