Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services to the global health science market, today shared results from the first multi-site, Phase II clinical trial to evaluate TheraSphere(R) for treatment of metastatic liver cancer.
The trial evaluated a variety of factors, including safety and tumour response, in patients with liver metastases-cancerous tumours that spread to the liver from other sites in the body. The overall tumour response, including stable disease, was 90% in metastatic neuroendocrine tumours and 69.2% in all treatment groups.
Initial analysis of the trial data led the researchers to suggest that TheraSphere is a safe, well-tolerated treatment for patients with liver metastases. The study yielded remarkably consistent results across all the centres.
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Dr. Riad Salem of Northwestern University in Chicago, IL, presented the findings yesterday at the annual scientific meeting of the Society of Interventional Radiology (SIR) in Chicago. The Global Principal Investigator was Dr. Al Benson III of Northwestern. The trial ran from 2007 to 2011 and involved 151 patients at the following five institutions:
* Northwestern University, Chicago, IL
* Albany Medical Center, Albany, NY
* Johns Hopkins University, Baltimore, MD
* Mayo Clinic, Rochester, MN
* Medical College of Wisconsin, Milwaukee, WI
"We are extremely pleased with the consistency of the results across all treating institutions," said Dr. Peter Covitz, Nordion's Senior Vice-President of Innovation. "This study will inform future development plans for TheraSphere."
About TheraSphere
TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the main artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood vessels.
TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. TheraSphere, 100% reimbursed by Medicare and many commercial health insurers, is used to treat patients with unresectable hepatocellular carcinoma (HCC) and can be used as a bridge to surgery or transplantation in these patients. It can also be used to treat primary liver cancer patients with portal vein thrombosis. TheraSphere is approved by the U.S Food and Drug Administration (FDA) under a Humanitarian Use Device (HUD) exemption. HUD approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.
