Intravenous Administration of REOLYSIN® for Patients with Metastatic Colorectal Cancer
In April 2011, Oncolytics announced positive interim data in a UK translational clinical trial investigating intravenous administration of REOLYSIN® in patients with metastatic colorectal cancer prior to surgical resection of liver metastases. On initial histological analysis of the ten treated patients to that date, there was evidence of selective delivery of virus to tumor versus normal liver and viral replication in the majority (seven) of patients. In two patients, only necrotic tumor was found; in one of these cases virus was detected in immune cells in the tumor. In six of ten patients there was no evidence of virus in the normal liver surrounding the tumor, with virus found only rarely in liver cells in the other four patients.
The trial (REO 013) is an open-label, non-randomized, single-center study of REOLYSIN® given intravenously to patients for five consecutive days in advance of their scheduled operations to remove colorectal cancer deposits metastatic to the liver. Patients will comprise two groups receiving REOLYSIN®, either at an early (ten to twenty-one days) or late (less than ten days) time point before surgical resection. After surgery, the tumor and surrounding liver tissue will be assessed for viral status and antitumor effects.
The primary objectives of the trial are to assess the presence, replication and anti-cancer effects of reovirus within liver metastases after intravenous administration of REOLYSIN® by examination of the resected tumor. Secondary objectives include assessing the antitumor activity and safety profile of REOLYSIN®, and monitoring the humoral and cellular immune response to REOLYSIN®.
The University of Leeds is covering all costs of the trial, while Oncolytics is providing REOLYSIN®. The principal investigator is Professor Alan Melcher of St. James's University Hospital.
- April 20, 2011: Oncolytics Biotech Inc. Announces Positive Data from Translational Clinical Trial Investigating REOLYSIN® in Patients with Metastatic Colorectal Cancer (Press Release)
- January 27, 2009: Oncolytics Biotech Inc. Announces Start of Patient Enrollment in Translational Clinical Trial Investigating REOLYSIN® in Patients with Metastatic Colorectal Cancer (Press Release)