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news.Oncolytics Biotech has completed patient enrolment in the dose escalation portion of its UK clinical trial to evaluate the anti-tumour effects of systemic administration of Reolysin in combination with paclitaxel and carboplatin in patients with advanced cancers including head and neck, melanoma, lung and ovarian.
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The trial (REO 011) has two components. The first is an open-label, dose-escalating, non-randomized study of Reolysin given intravenously with paclitaxel and carboplatin every three weeks. Standard dosages of paclitaxel and carboplatin were delivered to patients with escalating dosages of Reolysin intravenously. The second component of the trial includes the enrolment of a further 12 patients at the maximum dosage 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 tumours such as head and neck, melanoma, lung and ovarian cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The primary objective of the trial is to determine the maximum tolerated dose, dose-limiting toxicity, recommended dose and dosing schedule and safety profile of Reolysin when administered in combination with paclitaxel and carboplatin. Secondary objectives include the evaluation of immune response to the drug combination, the body’s response to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.
Brad Thompson, president and CEO of Oncolytics, said: “The preliminary results from this combination trial are very encouraging. This study was the first to begin examining the use of Reolysin with drug combinations that are used in first or second line therapy.”