REO 009 was an open-label, dose-escalating, Phase I trial of REOLYSIN® in combination with gemcitabine in patients with advanced or metastatic solid tumours, including breast and head and neck. Patients received gemcitabine on days 1 and 8 of each twenty-one day cycle, as well as escalating doses of REOLYSIN® on day 1. Fifteen patients were enrolled in the study. The primary objectives of the trial were to determine maximum tolerated dose, dose-limiting toxicities, safety profile, and recommended dose and dosing schedule of the treatment combination. Secondary objectives included the evaluation of immune response to the treatment combination, and evidence of anti-tumour activity.
The Company announced results from the study in June 2009. Of 10 patients who were evaluable for response, two patients (breast and nasopharyngeal) had partial responses (PR) and five patients had stable disease (SD) for between 4 and 8 cycles, for a total disease control rate (complete response (CR) plus PR + SD) of 70%.