Nordion Inc. yesterday announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct two Phase III clinical trials of its TheraSphere therapeutic radiopharmaceutical. Both trials are cleared under an FDA Investigational Device Exemption (IDE).
The first trial, dubbed the EPOCH study, is intended to assess the safety and effectiveness of TheraSphere in colorectal cancer patients whose disease has metastasized to the liver. To be conducted at up to 30 sites worldwide, the randomized trial has a target enrollment of approximately 350 patients. Mary Mulcahy, MD, of Northwestern University, will serve as the principal investigator.
In the second trial, to be known as the STOP-HCC study, Principal Investigator Riad Salem, MD, MBA, also of Northwestern University, and his colleagues will examine the safety and effectiveness of TheraSphere when added to standard kinase inhibitor therapy in patients with unresectable hepatocellular carcinoma, the most common form of inoperable primary liver cancer. For this study, Nordion has set a target enrollment of approximately 400 patients at up to 40 participating sites.
TheraSphere therapy consists of millions of small glass beads containing radioactive yttrium-90. The therapeutic radiopharmaceutical is injected into the main artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumor via blood vessels.