New Europe-focused Phase III Trial of TheraSphere (Nordion) for Liver Cancer

A new Phase III clinical trial for TheraSphere, a yttrium-90 (Y-90) glass microsphere treatment for Liver Cancer, from Nordion, will be focused primarily in Europe, with additional locations to be identified globally. This therapy consists of millions of microscopic, radioactive glass microspheres (20�30 micrometres in diameter) that are infused into the arteries that feed liver tumors. These microspheres then embolize, lodging themselves in the liver's capillaries and bathing the malignancy in high levels of beta radiation from yttrium-90. TheraSphere is approved by the FDA as a neoadjuvant to surgery or transplantation under a Humanitarian Device Exemption (HDE), based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established. Called YES-P, the new trial is targeting enrolment of about 350 patients at approximately 24 sites. The trial will further evaluate the safety and efficacy of TheraSphere in the treatment of patients with Portal Vein Thrombosis (PVT) associated with unresectable Hepatocellular Carcinoma (HCC). The trial will follow a two-armed design. In one arm, patients will undergo Y-90 radioembolization treatment with TheraSphere, while patients in the other arm will receive sorafenib. In the last 13 months, Nordion has also announced two additional Phase III clinical trials for TheraSphere: STOP-HCC, involving patients with HCC, and EPOCH, involving patients with colorectal cancer whose disease has metastasized to the liver.