CALGARY, Nov. 14, 2011 /PRNewswire/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that positive results from a Phase 2 clinical trial (REO 015) using intravenous administration of REOLYSIN ® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The conference is being held in San Francisco, CA from November 12 th to 16 th 2011. The Principal Investigator of the U.S. study was Dr. Monica Mita of the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio (CTRC).
The U.S. trial was a single arm open-label, phase-2 study of REOLYSIN given intravenously with paclitaxel (175 mg/m 2) and carboplatin (AUC 5) every three weeks in patients with platinum-refractory recurrent and/or metastatic squamous cell cancers of the oral cavity, larynx, or pharynx. The primary end point was to determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population. Secondary objectives included the determination of disease control rate (CR + PR + stable disease (SD)) and the safety and tolerability of the treatment regimen.
Of the 14 enrolled patients, all had received prior chemotherapy, radiotherapy, or combinations thereof for their metastatic or recurrent disease. Ten of the 14 patients received prior chemotherapy treatment with taxanes. Of the 13 patients evaluable for response, four had PRs, for an objective response rate of 31%. Six patients had SD or better for 12 weeks or longer for a disease control rate (SD or better) of 46%. Two of the four patients with PRs and both patients with SD had received prior treatment with taxanes.