A total of 30 patients have been treated in the Phase I/II trial, including 23 head and neck cancer patients. Of these head and neck patients, 17 patients have been treated in the Phase II portion of the trial. Eligible patients in the Phase II portion of the trial included those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists.
Interim results reported in March 2009 demonstrated that of 12 head and neck patients evaluable for clinical response, five had experienced a partial response and four had experienced stable disease ranging from two to six months, for a clinical benefit rate of 75%. Final results of the trial are expected to be released later in 2009.
An independent, confirmatory Phase II trial using the same combination of Reolysin and carboplatin/paclitaxel for patients with head and neck cancers is currently underway in the US.
Brad Thompson, president and CEO of Oncolytics Biotech, said: "This is an outstanding response rate in this difficult-to-treat patient population, and formed the basis of the Phase III pivotal program now being developed for Reolysin in combination with carboplatin/paclitaxel for head and neck cancer patients."
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