Nordion Reports TheraSphere(R) Phase II Clinical Trial Results at Society of Interventional Radiology
By Nordion Inc., PRNESunday, March 27, 2011
Preliminary Analysis Shows Treatment is Well-Tolerated and Consistently Delivered to Patients With Metastatic Liver Cancer
OTTAWA, March 28, 2011 - 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.
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.
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 at
www.nordion.com/therasphere.
About Nordion Inc.
Nordion Inc. (TSX: NDN) (NYSE: NDZ) is a global specialty 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 600 highly skilled employees in four locations. Find
out more at www.nordion.com.
Forward Looking Statements
Certain statements contained in this news release constitute
"forward-looking statements". These statements are based on current beliefs
and assumptions of management, however are subject to known and unknown
risks, uncertainties and other factors that may cause actual results to
differ materially from the forward-looking statements in this news release.
For additional information with respect to certain of these beliefs,
assumptions, risks and uncertainties, please refer to Nordion's Annual
Information Form for fiscal 2010 available on SEDAR at www.sedar.com
and on EDGAR on www.sec.gov.
CONTACTS: MEDIA: Shelley MacLean +1(613)592-3400 x. 2414 shelley.maclean@nordion.com Kirsten Fallon Schwartz Communications +1(781)684-0770 Nordion@Schwartzcomm.com INVESTORS: Ana Raman +1(613)595-4580 investor.relations@nordion.com
CONTACTS: MEDIA: Shelley MacLean, +1(613)592-3400 x. 2414, shelley.maclean at nordion.com; Kirsten Fallon, Schwartz Communications, +1(781)684-0770, Nordion at Schwartzcomm.com; INVESTORS: Ana Raman, +1(613)595-4580, investor.relations at nordion.com
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