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FDA grants orphan drug designation to Reolysin for ovarian cancer
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The FDA granted orphan drug designation to Reolysin for the treatment of ovarian cancer, according to a press release from the drug’s manufacturer.
Reolysin (pelareorep, Oncolytics Biotech) is the manufacturer’s lead product candidate for the treatment of ovarian cancer.
"This is an important regulatory milestone for Oncolytics and will provide us with a number of benefits as we advance the development and commercialization process for Reolysin," said Brad Thompson, PhD, president and CEO of Oncolytics Biotech. "Ovarian cancer is a devastating disease that represents a significant unmet need, particularly for those patients diagnosed in later stages."
Oncolytics Biotech sponsored a phase 1/2 clinical trial (OSU-07022) to assess pelareorep in patients with metastatic ovarian, peritoneal and fallopian tube cancers. Results showed evidence of viral targeting and replication in peritoneal and ovarian cancer cells.
A second ongoing randomized phase 2 trial (GOG186H) is being conducted to evaluate weekly paclitaxel vs. weekly paclitaxel with pelareorep in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer.