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news.Oncolytics Biotech has made a decision to pursue a pivotal Phase II/III randomized trial using the combination of Reolysin with paclitaxel/carboplatin in refractory patients with head and neck cancers.
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The decision was made following a review of results by the company’s board of directors from the company’s ongoing UK Phase I and Phase II combination Reolysin and paclitaxel/carboplatin clinical trials.
Oncolytics is currently convening a group of experts in Europe and the US to design a protocol for the Phase II/III trial, which will then be submitted to the FDA, and the European Medicines Agency (EMEA) for review. Following FDA and EMEA review, Oncolytics expects to file for approval for this trial early in 2009.
Brad Thompson, president and CEO of Oncolytics, said: “Approximately eight out of nine head and neck patients reported on to date from the Phase I and Phase II studies had either a partial response or stabilization of disease. This response rate exceeds that of the current standard of care for this patient group, and more than warrants proceeding to a pivotal program.”