Nordion announces additional TheraSphere Phase III trial for HCC
Published on April 24, 2012 at 2:43 AM
Nordion Inc. (TSX: NDN) (NYSE: NDZ), a
leading provider of products and services for the prevention, diagnosis
and treatment of disease, today announced an additional randomized,
multi-centre Phase III clinical trial for TheraSphere®, Nordion's yttrium-90 (Y-90) glass microsphere treatment for liver cancer.
The YES-P trial will be focused primarily in Europe, with additional
locations to be identified globally, and is targeting enrolment of
about 350 patients at approximately 24 sites. The trial will further
evaluate the safety and efficacy of TheraSphere® in the treatment of patients with portal vein thrombosis (PVT)
associated with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
PVT, a complication in which a clot forms in one of the blood vessels
feeding the liver, occurs in approximately 30 to 40% of HCC cases. The
presence of PVT is a contraindication for most embolic therapies, but
TheraSphere® represents a safe alternative.
"Nordion is excited to directly address the important question of
whether TheraSphere® can extend the lives of this sub-group of HCC patients, where typical
life expectancy remains unacceptably low," said Mason Ross, MD,
Nordion's Vice President of Medical Affairs. "YES-P is our first major
clinical trial that will be primarily conducted in Europe, thus
supporting our commitment to increase our global clinical research
footprint while building on the knowledge of how TheraSphere® may improve survival compared to sorafenib."
The trial will follow a two-armed design. In one arm, patients will
undergo Y-90 radioembolization treatment with TheraSphere®, while patients in the other arm will receive sorafenib.
In the last 13 months, Nordion has also announced two additional Phase
III clinical trials for TheraSphere®: STOP-HCC, involving patients with HCC, and EPOCH, involving patients
with colorectal cancer whose disease has metastasized to the liver.