Nordion has received U.S. Food and Drug Administration (FDA) approval to conduct two phase III clinical trials for its TheraSphere therapeutic radiopharmaceutical.
Both clinical trials have received an investigational device exemption (IDE) from the FDA. One study will evaluate the safety and effectiveness of TheraSphere in colorectal cancer patients whose disease has metastasized to the liver. This randomized trial, to be known as the EPOCH study, will take place at up to 30 sites worldwide, with a target enrollment of approximately 350 patients. The principal investigator will be Dr. Mary Mulcahy of Northwestern University.
The second trial 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. This study has a target enrollment of approximately 400 patients at up to 40 participating sites. The principal investigator will be Dr. Riad Salem, a colleague of Mulcahy's at Northwestern.
