REO 011 was a single-arm, open-label, dose-targeted Phase I/II trial of REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory, recurrent and/or metastatic squamous cell cancers of the oral cavity, larynx or pharynx. Patients received paclitaxel and carboplatin on day 1 of each twenty-one day cycle, with either REOLYSIN® administered on days 1 through 5. Fourteen patients were enrolled in the study. The primary objectives were tumour response, duration of response, and evidence of anti-tumour activity. The secondary objective was to assess the safety and tolerability of the treatment regimen.
Results from the study were presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference in November 2009. The investigators reported that REOLYSIN® was well tolerated when administered intravenously in combination with paclitaxel and carboplatin. Of 19 evaluable patients, eight experienced partial responses and six had stable disease. The total clinical benefit rate (complete response plus partial response plus stable disease) was 74%. Of four patients with malignant melanoma on the trial, one experienced a partial response and one had stable disease.
The Company has also conducted an independent, confirmatory US Phase II study, REO 015 using the same treatment combination.