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FDA grants orphan drug designation to Reolysin for fallopian tube cancer
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The FDA today granted orphan drug designation to pelareorep for the treatment of fallopian tube cancer, according to a press release from the drug’s manufacturer.
Pelareorep (Reolysin, Oncolytics Biotech) has been analyzed in two sponsored clinical studies in patients with cancer of the fallopian tube.
The first was a phase 1/2 clinical trial evaluating patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent IV and intraperitoneal administration of pelareorep. Data provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells.
A second ongoing randomized phase 2 trial is assessing weekly paclitaxel vs. weekly paclitaxel with pelareorep in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. Enrollment for this trial concluded in September.
"The FDA's recognition of ovarian and fallopian tube cancers as distinctly separate indications paves the way for a more targeted approach to the treatment of gynecological cancers," Brad Thompson, PhD, president and CEO of Oncolytics, said in a press release. "We are pleased to have secured our third orphan drug designation in the United States and look forward to continuing our development and commercialization program for Reolysin."