Positive results from Oncolytics REOLYSIN combination Phase 2 clinical trial for head and neck cancers

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/m²) 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.

"This study was undertaken as a confirmatory trial of an earlier study performed in the UK with a similar patient population (REO 011). It confirmed the high rate of responses observed in the U.K. study, and was noteworthy as this U.S. patient population included a higher proportion of patients that had failed prior taxane-based therapy," said Dr. Matt Coffey, COO of Oncolytics. "Historically, head and neck cancer has been characterized by a very low rate of success in treatment of patients who have already failed chemotherapy. Standard second-line therapies for platinum refractory head and neck cancer using currently approved cytotoxics have yielded 3 to 7% response rates."

"These data further confirm the utility of REOLYSIN in this indication, even in a heavily pre-treated patient population," said Dr. Brad Thompson, President and CEO of Oncolytics. "These results are an important step towards making this potential therapy available to head and neck cancer patients, and represent a significant milestone for Oncolytics."

SOURCE Oncolytics Biotech Inc.