Oncolytics Biotech Inc has started a Phase I/II brain cancer clinical trial with Reolysin. The study is expected to enrol approximately 38 patients who have been diagnosed with recurrent malignant glioma, an aggressive and deadly form of brain tumour. Recurrent malignant glioma is often characterized by activation of the RAS pathway, and Reolysin, developed from the naturally occurring reovirus, has been shown to infect and kill cancer cells with these mutations.

"Beginning this study is a significant milestone for Oncolytics and for the treatment of this persistent disease," said Dr. Brad Thompson, President and CEO of Oncolytics. "In various pre-clinical animal studies conducted to date, we have seen promising tumour response and lifespan extension with reovirus, so we are hopeful about using reovirus as a potential treatment in humans for this type of tumour."

Research published in the June 20, 2001 issue of the Journal of the National Cancer Institute showed that mice treated with a single injection of reovirus experienced benefits including complete tumour regression in 20 of 23 treated animals and a statistically significant increase in survival. Reovirus killed cancer cells from 19 of 24 established glioma cell lines and from all nine glioma surgical specimens.

In the dose escalation or Phase I portion of the Phase I/II trial, patients with a variety of recurrent malignant gliomas will be enrolled. In the Phase II portion of the trial, patients with recurrent glioblastoma multiforme, the most aggressive glioma, will be treated with doses of Reolysin determined by the results of the Phase I study.

Malignant brain tumours occur in approximately 40,000 patients in North America and Europe each year, survival rates are low and the probability of tumour recurrence is high. The standard treatment for patients with newly diagnosed malignant gliomas is surgery, followed by radiation therapy and occasionally systemic chemotherapy.