FDA approves Nordion's TheraSphere IDE for Phase III trial to treat HCC

Mar 23 2011

Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services to the global health science market, today announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct a Phase III clinical trial for TheraSphere® under an Investigational Device Exemption (IDE).  The trial will examine the safety and effectiveness of TheraSphere when the treatment is added to standard kinase inhibitor therapy in patients with unresectable hepatocellular carcinoma (HCC), the most common form of inoperable primary liver cancer.

The trial, known as the STOP-HCC study, is a randomized Phase III clinical trial that will take place at up to 40 sites around the world, and will enrol approximately 400 patients. The Principal Investigator is Dr. Riad Salem, Professor of Radiology, Medicine and Surgery and Director, Interventional Oncology at Northwestern University in Chicago, IL.

The two-arm trial will examine a number of safety and efficacy endpoints. In one arm, patients will undergo yttrium-90 (Y-90) radioembolization treatment with TheraSphere prior to receiving standard kinase inhibitor therapy, while in the other arm only the standard kinase inhibitor therapy will be used. The Company intends to design the trial to comply with all FDA and institutional review board requirements in the U.S. and to meet all relevant regulatory requirements for the study of an investigational device in other countries.

"Nordion worked closely with many investigators (medical and radiation oncologists, hepatologists, transplant surgeons, interventional radiologists) to develop this trial, which will evaluate whether TheraSphere provides an added benefit to kinase inhibitor therapy," said Dr. Salem. "Since these therapies have different mechanisms of action, the study aims to demonstrate an added effect."

According to GLOBOCAN 2008, a publication of the International Agency for Research on Cancer, primary liver cancer is the third most common cause of death from cancer. The majority of cases occur in people aged 45 or older. The overall five-year survival rate following diagnosis is low, highlighting an unmet medical need in treating this disease.

"Nordion is committed to working with the medical community to collect data to determine whether TheraSphere provides significant added benefit to HCC patients being treated with standard kinase inhibitor therapy," said Dr. Peter Covitz, Nordion's Senior Vice-President of Innovation. "This Phase III trial will advance our understanding of clinical applications for TheraSphere, and will evaluate its potential benefit in this setting."