Oncolytics Biotech Inc announced positive interim safety results from the Phase I component of its clinical study examining the use of Reolysin in the treatment of recurrent malignant glioma, the most aggressive form of brain cancer. The Company reported that Reolysin appeared to be well tolerated when surgically delivered into the brain during the treatment of the first six patients.
Determination of the safety of Reolysin is the primary purpose of the Phase I study. The study is examining the use of a single, intratumoural injection of Reolysin delivered using imaging-guided surgery, in patients with malignant glioma that has recurred despite other treatments, including surgery and radiation therapy. After treatment with Reolysin, the Phase I patients are monitored and evaluated for safety for a period of six months. Five of the six treated patients remain alive and on study with duration after treatment ranging between 10 and 25 weeks. One patient died of progressive disease after leaving the study, but no severe adverse effects attributable to the virus were seen in this patient.
An independent data safety monitoring board was established at the start of the trial and recently completed its first scheduled review, which included the results seen in the first six patients. The board has recommended continuing the trial. It further recommended changes be made to enhance the measurement of the safety and efficacy of Reolysin in the intended patient population in future studies. The physician investigators have also made observations during the care of the six patients that may lead to protocol changes. As is standard practice, until the clinical data and proposed changes have been reviewed and approved by the regulatory agencies, no new patients are being enrolled.