Study to evaluate and compare safety and efficacy of TheraSphere® vs. sorafenib in hepatocellular carcinoma patients with portal vein thrombosis
OTTAWA, April 24, 2012 /CNW/ - Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services for the prevention, diagnosis and treatment of disease, today announced an additional randomized, multi-centre Phase III clinical trial for TheraSphere®, Nordion's yttrium-90 (Y-90) glass microsphere treatment for liver cancer.
The YES-P trial will be focused primarily in Europe, with additional locations to be identified globally, and 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 most common form of primary liver cancer.
PVT, a complication in which a clot forms in one of the blood vessels feeding the liver, occurs in approximately 30 to 40% of HCC cases. The presence of PVT is a contraindication for most embolic therapies, but TheraSphere® represents a safe alternative.
"Nordion is excited to directly address the important question of whether TheraSphere® can extend the lives of this sub-group of HCC patients, where typical life expectancy remains unacceptably low," said Mason Ross, MD, Nordion's Vice President of Medical Affairs. "YES-P is our first major clinical trial that will be primarily conducted in Europe, thus supporting our commitment to increase our global clinical research footprint while building on the knowledge of how TheraSphere® may improve survival compared to sorafenib."
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.
TheraSphere® is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive Y-90. The product is injected by physicians into the artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.
TheraSphere® is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters.
In the US, TheraSphere® is used to treat patients with HCC who can have placement of appropriately positioned hepatic arterial catheters, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with partial or branch portal vein thrombosis or occlusion when clinical evaluation warrants the treatment. TheraSphere® is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.
Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere® package insert/instructions for use at www.nordion.com/therasphere.
About Nordion Inc.
Nordion Inc. (TSX: NDN) (NYSE: NDZ) is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at www.nordion.com and follow us at http://twitter.com/NordionInc.
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