The first stage of enrollment has been completed in a phase III clinical trial that will examine the use of a human reovirus, in combination with chemotherapy, in patients with head and neck cancer. Oncolytics Biotech Inc. announced April 2 that it has enrolled 80 patients in the trial of Reolysin, a variant of the respiratory enteric orphan virus. The patients, who have platinum-refractory head and neck cancers, will receive Reolysin in combination with paclitaxel and carboplatin.
“This is an important milestone for this study,” Brad Thompson, PhD, president and CEO of Oncolytics in Calgary, Canada, said in a press release. “A data analysis that will involve examining evolving progression-free survival will now be performed on this patient group to determine the probability of success in the second stage of the study.”
The randomized, double-blind trial will assess the intravenous administration of Reolysin with the two chemotherapy drugs versus chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. It is being conducted in 80 centers in 12 countries in North America and Europe. The primary endpoint is overall survival.
Reolysin works by infecting patients with the reovirus, to which most people have been exposed by adulthood, and which typically causes few or no symptoms, the company said. Normal cells are able to fight the infection, but cancer cells with Ras gene mutations cannot, and the unchecked multiplication of the virus kills them by causing them to rupture. Then, the virus moves on to destroy nearby tumor cells. (NCT01166542)