Oncolytics Cleared to Initiate Phase I/II Recurrent Malignant Gliomas Trial

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 recurrent malignant gliomas.

The principal investigator for the trial is James Markert, professor of neurosurgery and physiology at the University of Alabama at Birmingham. 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 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 enrollment in this study is expected to include up to 30 evaluable patients in the dose-escalation phase with up to an additional 14 patients added at the MTD.