REO 005 was an open-label, dose-escalation Phase I study of REOLYSIN® monotherapy in patients with various advanced stage, primary or metastatic tumours who had previously failed standard cancer therapies. Approximately 30 patients were enrolled, and received escalating doses of intravenously administered REOLYSIN®. The primary objective was to determine the safety of REOLYSIN® when administered intravenously. The secondary objective was to observe tumour and immune system responses to the treatment.
Final results from the study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2007. The study indicated that REOLYSIN® could be delivered systemically to various tumour types and cause virus-mediated tumour responses. A maximum tolerated dose was not reached, and the treatment was well tolerated by patients.