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Oncolytics to initiate Phase II trial of intravenous cancer therapy

Oncolytics Biotech has received a letter of approval from the UK Medicines and Healthcare products Regulatory Agency, for its clinical trial application to begin a Phase II clinical trial using intravenous administration of Reolysin in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers.

This trial is a 14 patient, single arm, open-label, dose-targeted, non-randomized, multi-centre trial of Reolysin given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Patients with a variety of advanced cancers, including head and neck cancers, will continue to be treated in the ongoing UK combination paclitaxel and carboplatin trial.

Eligible patients include those with advanced or metastatic head and neck cancer that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase II trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of Reolysin when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancer.