Oncolytics Biotech Inc, a company developing Reolysin (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumours hot, has reached an agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the company's phase 3 study evaluating pelareorep for the treatment of metastatic breast cancer. The company previously received Fast Track Designation for pelareorep for the treatment of metastatic breast cancer in May 2017.
"This agreement with the FDA, outlining the specific clinical pathway forward in metastatic breast cancer, is an important milestone in advancing pelareorep along a path to potential regulatory approval," said Dr. Matt Coffey, president and CEO of Oncolytics Biotech. "It’s a confirmation from the FDA that our design and protocols will support an application for approval and advances pelareorep to be a phase 3 asset. We now look forward to implementation of the Agency’s guidance and to the advancement of pelareorep through this final phase of clinical development."
Reolysin, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumours and haematological malignancies. The compound induces selective tumour lysis and promotes an inflamed tumour phenotype through innate and adaptive immune responses to treat a variety of cancers.