REO 003 was an open-label, single-arm Phase I study of REOLSYIN® as a monotherapy for patients with recurrent malignant gliomas. A total of twelve patients were enrolled, each of whom received a single, intratumoural injection of REOLYSIN®. The primary objectives of the study were to determine the maximum tolerated dose, dose-limiting toxicity and safety profile of intratumourally administered REOLYSIN®. A secondary objective was to assess evidence of anti-tumour activity.
Final results of the study were presented by Oncolytics collaborators at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2006. The treatment was well tolerated by patients and a maximum tolerated dose was not reached. Toxicities possibly related to the REOLYSIN® treatment in this trial were generally mild (grade 1 and 2) and included fever, headache and neutropenia. A transient grade 3 elevation in GGT was noted. Three patients lived longer than one year, and one of these patients was still alive at the time of the analysis, approximately 45 months post-treatment.