REO 012 was an open-label, dose-escalating, non-randomized trial of REOLYSIN® given intravenously with escalating doses of cyclophosphamide in patients with advanced or metastatic solid tumours, including pancreatic, lung and ovarian cancers that had not responded to standard therapy. Patients received REOLYSIN® on days 1 through 5 of each twenty-eight day treatment cycle, with cyclophosphamide 3 days prior to the start of the first cycle and then on day 26 of each cycle in the absence of dose limiting toxicities. Approximately 30 patients were enrolled. The primary objectives of the trial were safety, minimum effective immunomodulatory dose, and maximum tolerated dose, if reached. The secondary objectives were dose limiting toxicities, and to gather preliminary evidence of anti-tumour activity for the treatment combination.
Results from the study were published in the journal Clinical Cancer Research in March 2015. The treatment combination was reported to have been safe and well tolerated in all patients, with Grade 3 or 4 toxicities seen only in patients at or above the maximum tolerated dose of cyclophosphamide. Immunosuppressive effect, defined as maintaining NARA titer rise below a predefined threshold, was observed in one patient.