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Breaking News - FDA Clears Oncolytics Brain-Tumor Trial

Posted on: 02/28/2005

Breaking News - FDA Clears Oncolytics Brain-Tumor Trial

Published: February 28, 2005 8:52 AM

CALGARY (Dow Jones)--Oncolytics Biotech Inc. (ONCY) has received clearance from the U.S. Food and Drug Administration to begin a Phase I/II clinical trial to investigate the use of REOLYSIN to treat patients with recurrent malignant gliomas.

In a press release, the company said the principal investigator for the trial is Dr. James Markert, professor, neurosurgery and physiology, the University of Alabama at Birmingham.

The company said the U.S. study will complement its Canadian recurrent malignant gliomas study by employing an alternative method of product delivery to the tumor site in the brain.

The 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. Oncolytics said the primary objective of the study is to determine the maximum tolerated dose, 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 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 maximum tolerated dose.

Oncolytics is a biotechnology company.

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