Following this Medicines and Healthcare products Regulatory Agency (MHRA) approval, the trial will now enroll approximately 30 evaluable patients at the Royal Marsden and St James’s Hospitals in the UK.
The trial is a phase I open-label, dose-escalation study of Reolysin, a formulation of the human reovirus, combined with two different radiation dosages/schedules. The primary objective of the study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of Reolysin when administered intratumorally to patients receiving radiation treatment.
A secondary objective is to examine any evidence of anti-tumor activity. Patients who have been diagnosed with advanced or metastatic solid tumors that are refractory to standard therapy or for which no curative standard therapy exists will be eligible.
“In animal models, radiation therapy used in combination with Reolysin had more effect than either agent by itself.” said Dr Brad Thompson, president and CEO of Oncolytics. “This clinical trial will be the first to examine the effects of intratumoral delivery of Reolysin in combination with radiation.”