Sunday, April 3, 2011

Nordion reported TheraSphere ® phase II study results at society interventionelle Radiology


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Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services for the global health science to marketing, shared results from the first multi-site, phase II clinical trial of TheraSphere ® for the treatment of metastatic liver evaluated.

The study was tumors that spread from other sites in the body to the liver a variety of factors from, including security and tumor response in patients with cancer liver metastases. The tumor response as a whole, including stable disease, was 90% for patients with metastatic neuroendocrine tumors and 69.2% in all treatment groups.

Initial analysis of the studies data led to the researchers to that TheraSphere is safe, well tolerated treatment of patients with liver metastases. The study showed remarkably consistent results of the centres.

Dr. Riad Salem Northwestern University in Chicago, IL, yesterday presented the findings at the annual scientific meeting of the society of Interventional Radiology (SIR) in Chicago. The global principal investigator was Dr. Al Benson III Northwestern. The trial ran from 2007 to 2011 and 151 patients involved in following five facilities:

-Northwestern University, Chicago, IL

-Albany Medical Center in Albany, NY

--Johns Hopkins University, Baltimore, MD

-Mayo Clinic, Rochester, MN

-Medical College of Wisconsin, Milwaukee, WI

"We very pleased with the consistency of the results of all the institutions", said Dr. Peter Covitz, Nordion's Senior Vice President of innovation. "Plans for the future development for TheraSphere inform this study."

About TheraSphere

TheraSphere is a liver cancer therapy that consists of millions of small beads (20 to 30 microns in diameter), the radioactive yttrium-90 (Y-90). The product will be delivered injected allows the treatment directly to the tumor via blood vessels by doctors in the main artery of liver patients through a catheter.

TheraSphere treatment can be managed on the outpatient basis and usually requires one night hospital. TheraSphere, 100% of Medicare and many commercial health insurance will be reimbursed for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and acts as a bridge to the surgery or transplantation in these patients. It can also be used, for the treatment of patients with Portal vein thrombosis primary liver cancer. TheraSphere exemption approved by the U.S. food and Drug Administration (FDA) is under a humanitarian use device (HUD). HUD permits are based on proven security and probably clinical benefit. However, effectiveness of the indication for the use was not mounted.

Common side effects are mild to moderate fatigue, pain and nausea for about a week. Doctors describe where the flu as similar to these symptoms. Some patients experience some loss of appetite and temporary changes in some blood tests.

Source: Nordion Inc
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