first patient implanted pancreatic cancer study

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First Patient Implanted in pSivida European Pancreatic Cancer Study

Last Update: 8:01 AM ET Oct 9, 2006

BOSTON & PERTH, Australia, Oct 09, 2006 (BUSINESS WIRE) -- Global bio-nanotech company pSivida

Limited (PSDV :
psivida ltd sponsored adr


9:33am 10/09/2006

PSDV2.40, +0.20, +9.1% ) (ASX:PSD)(Xetra:PSI) today announced that the first patient has been implanted with BrachySil™ for the treatment of inoperable pancreatic cancer at Guys and St Thomas' NHS Foundation Trust Hospital in London, a major center for cancer therapy in the United Kingdom.

The treatment delivers BrachySil™ directly to a tumor in the pancreas via endoscopic ultrasound (used to assist in locating the delivery point). BrachySil™ is a novel oncology product that is comprised of a combination of BioSilicon™ and the isotope 32Phosphorus, a proven anti-cancer therapeutic. The targeted and localized nature of the product could potentially provide oncologists with an effective and user-friendly treatment for this disease which has a high unmet clinical need.

Pancreatic cancer has one of the lowest cancer survival rates (five year relative survival rate of approximately 5%) with 85-90% of patients being diagnosed with the inoperable form of the disease. There is significant clinical and market demand for effective therapies to treat this aggressive form of cancer. According to (a)GLOBOCAN, there were over 230,000 new cases and nearly as many deaths from pancreatic cancer worldwide in 2002. Approximately 50% of these new cases were in North America and Europe.

The primary objective of the six-month clinical study is to determine the safety of the image-guided implantation of BrachySil™. Efficacy, as determined by computerized tomography scanning of the tumor size and overall survival, will be secondary endpoints. The trial is being conducted in both Europe and Asia with a second clinical center at the Singapore General Hospital and the National Cancer Center Singapore. The findings will provide a platform for further multicenter efficacy and safety trials.

Pancreatic cancer is the second clinical indication for BrachySil™, currently in Phase IIb clinical trials for the treatment of inoperable primary liver cancer. A Phase IIa study in inoperable primary liver cancer was completed in July 2005 and showed BrachySil™ to be well tolerated. All patients experienced a decrease in the size of their tumors, with some experiencing complete tumor regression.

"We believe that the first trial in man of BrachySil™ for the treatment of inoperable pancreatic cancer represents a significant next step to bringing an effective treatment for an aggressive cancer that presently has a very low survival rate," said Dr. Roger Brimblecombe, CEO and Executive Chairman of pSivida Limited. "This trial expands our clinical development program for BrachySil™, our novel oncology product, into an additional solid tumor indication for which current therapies are very inadequate".