Nordion Awards Contract for Phase III Clinical Trials to Theorem Clinical Research
By Nordion Inc., PRNEWednesday, June 15, 2011
OTTAWA, June 16, 2011 -
Experienced CRO Provides
Implementation Services for TheraSphere® Clinical
Trials
Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of
products and services to the global health science market, today
announced that Theorem Clinical Research, previously Omnicare
Clinical Research, a full service Contract Research Organization
(CRO) has been awarded the contract to conduct Nordion’s recently
announced TheraSphere Phase III clinical trials for the treatment
of primary and metastatic liver cancers - STOP-HCC and
EPOCH.
During the multi-year contract, Theorem Clinical Research will
provide clinical trial implementation services which include
clinical data management, statistical analysis, monitoring, and
administrative expertise to support the conduct of the
studies. The trials are designed to evaluate the safety and
effectiveness of TheraSphere.
In March 2011, the U.S. Food and Drug Administration approved
Nordion’s clinical trial applications for both primary and
secondary liver cancer. The trial for primary liver cancer
currently envisages approximately 400 patients at up to 40 sites
around the world. The secondary liver cancer trial is
expected to include approximately 350 patients at up to 30 sites
worldwide.
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 is approved by the U.S Food and Drug Administration
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.
TheraSphere treatment can generally be administered on an
outpatient basis and does not usually require an overnight hospital
stay. TheraSphere, reimbursed by Medicare and a number of major
commercial health insurers in the U.S., 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.
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
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 500 highly skilled employees in three
locations. Find out more at
About Theorem Clinical Research
(previously Omnicare Clinical Research)
Theorem Clinical Research is a leading global, full-service
contract research organization (CRO) headquartered in King of
Prussia, Pennsylvania. With office locations in 32 countries, the
firm has relationships with customers all across the globe
comprised of some of the world’s leading pharmaceutical, biotech
and medical device companies. Theorem’s core CRO services are Early
Phase, Phase II/III and Late Phase and the company features
specialized Business Units focused on medical device, technical
services and pharmaceutics. For more information on Theorem, visit:
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
on www.sec.gov.
For further information:
MEDIA:
Shelley Maclean
+1-(613)-592-3400 x.2414
INVESTORS:
Ana Raman
+1-(613)-595-4580
.
Tags: canada, June 16, Nordion Inc., Ottawa
