Oncolytics Biotech Inc. has received clearance from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial to investigate the systemic delivery of Reolysin as a treatment for patients with advanced or metastatic solid tumours.

This clinical trial is an open-label, dose-escalation Phase I study in which a single dose of Reolysin will be administered intravenously to patients diagnosed with selected advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.

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 anti-tumour activity.

"This is our second clinical trial investigating the systemic administration of Reolysin in patients with advanced cancers," Dr. Brad Thompson, President and CEO of Oncolytics said adding, "Systemic administration of Reolysin for the treatment of advanced or metastatic cancer, either as a monotherapy or in combination with radiation therapy or chemotherapy, addresses the largest patient population and market opportunity."

The principal investigator for the trial is Dr. Sanjay Goel, Assistant Professor and Attending Physician in the Department of Medical Oncology, Montefiore Medical Center and Albert Einstein College of Medicine, New York City.