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news.Canada-based Oncolytics Biotech has received clearance from the FDA to begin a phase I/II clinical trial to investigate the use of Reolysin to treat patients with brain cancer in the US.
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This clinical trial is an open-label dose escalation phase I/II study in which a single dose of Reolysin will be administered by infusion to patients with recurrent malignant gliomas that are refractory to standard therapy.
The administration involves the stereotactically-guided placement of a needle into the tumor, through which Reolysin will be administered or infused into the tumor mass and surrounding tissue using a pump.
The primary objective of the study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and safety profile of Reolysin. Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of antitumor activity.
The enrolment in this study is expected to be up to 30 evaluable patients in the dose escalation phase with up to an additional 14 patients added at the MTD.
“Treatment of specific cancers, such as brain cancer, with local or regional administration of Reolysin is part of Oncolytics’ clinical strategy,” said Dr Brad Thompson, president and CEO of Oncolytics. “The US study will complement our Canadian recurrent malignant gliomas study by employing an alternative method of product delivery to the tumor site in the brain.”