FDA grants ODD for REOLYSIN (pelareorep) for treatment of malignant glioma

Industry News

The FDA has granted ODD for REOLYSIN (pelareorep) for the treatment of malignant glioma, a type of brain tumor with poor prognosis and lack of effective treatment options.  REOLYSIN is a proprietary variant of the reovirus being developed by the Calgary, Canada based company, Oncolytics Biotech.  REOLYSIN is non-pathogenic and is capable of infect and selectively destroy cancer cells.  It received ODD from the FDA in February for pancreatic and ovarian cancers, and in March for Fallopian tube and primary peritoneal cancers this year.  Currently, the company is sponsoring two Phase I/II trials in the US and Canada evaluating REOLYSIN’s efficacy in patients with recurrent malignant glioma.


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