Oncolytics Biotech has announced positive interim results in its Phase I and Phase II UK combination Reolysin and paclitaxel/carboplatin clinical trials for patients with advanced cancers.
Four of the responding patients continue on study, while a fifth patient is too early to evaluate for response, the company said. These results appear to confirm preclinical evidence of synergy for Reolysin and platinum/taxane combinations. A US Phase II trial has now been opened in this patient population utilizing this regimen.
The Phase I trial has two components. The first is an open-label, dose- escalating, non-randomized study of Reolysin given intravenously to patients with paclitaxel and carboplatin every three weeks. In this portion of the trial, standard dosages of paclitaxel and carboplatin are delivered to patients with escalating dosages of Reolysin intravenously.
The second component of the trial includes the enrollment of a further nine patients at the top dose of Reolysin in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those who have been diagnosed with advanced or metastatic solid tumors such as melanoma, lung and ovarian that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.
The Phase II trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of Reolysin given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists.
George Gill, Oncolytic’s senior vice president of clinical and regulatory affairs, said: “The most striking finding is that in nine evaluable late-stage head and neck cancer patients, eight of whom have refractory disease, four had durable partial responses and four others showed stable disease for periods of two, five plus, and eight cycles.”