Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced updated results from a Phase I/II U.K. trial (REO 011) of REOLYSIN(R) combined with paclitaxel/carboplatin for patients with advanced cancers in a poster presentation at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference being held in Boston, Massachusetts. The poster presentation is entitled "Phase I/II Trial of Oncolytic Reovirus (REOLYSIN) in Combination with Carboplatin/Paclitaxel in Patients with Advanced Solid Cancers with Emphasis on Squamous Cell Carcinoma of the Head and Neck (SCCHN)."
The investigators reported that REOLYSIN was well tolerated when administered intravenously in combination with paclitaxel and carboplatin. Of 19 evaluable patients with head and neck cancer, mostly SCCHN refractory to prior platinum-based chemotherapy for recurrent/metastatic disease, eight experienced partial responses and six had stable disease. The total clinical benefit rate (complete response + partial response + stable disease) observed in head and neck cancer patients in the trial was 74%. Of four patients with malignant melanoma on the trial, one experienced a partial response and one had stable disease.
"A 42% response rate and a 74% clinical benefit rate in a platinum refractory patient population that typically has a poor prognosis and limited therapeutic options is very encouraging," said Dr. Brad Thompson, President and CEO of Oncolytics. "These results further validate our decision to advance REOLYSIN in combination with paclitaxel and carboplatin into a Phase III trial in this patient population."
An independent, confirmatory Phase II trial (REO 015) using the same combination of REOLYSIN and carboplatin/paclitaxel for patients with head and neck cancers is currently underway in the U.S. Interim results from both the U.K. and the U.S. studies formed the basis for the Company's decision to conduct a Phase III pivotal program looking at REOLYSIN in combination with carboplatin/paclitaxel in this patient population. The Company has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of the Phase III trial.