Intravenous administration of Reolysin®, a live replication competent RNA virus is safe in patients with advanced solid tumors

Abstract

Summary: Background Reolysin® is reovirus serotype 3-Dearing strain, a double-stranded replication-competent RNA non-enveloped icosahedral virus. It induces cytopathic and anti-cancer effects in cells with an activated ras pathway due to inhibition of the dsRNA-activated protein kinase. Methods This was a single center dose escalation trial of Reolysin administered intravenously every 4 weeks in doses ranging from 1×108 to 3×10 10 tissue culture infective dose (TCID)50. Serum for neutralizing antibody, and serum, stool, saliva, and urine for viral shedding were collected. Tumor samples were analyzed for activating mutations in the ras and braf oncogenes. Results Eighteen patients received 27..