pSivida commences human trials of cancer treatment

Perth-based nanotechnology company pSivida Ltd has announced the first human trial of their pancreatic cancer treatment BrachySil, the first step in a six-month clinical study.

The company, which is now effectively run from Boston, reported a loss of $31.4 million for the year to June 2006, reflecting an increase in research and development, spending and sales and administration expenses.

The full text of a company announcement is pasted below

Global bio-nanotech company pSivida Ltd is pleased to announce 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 centre for cancer therapy in the United Kingdom.

The treatment delivers BrachySil directly to a tumour in the pancreas via endoscopic ultrasound (used to assist in locating the delivery point). BrachySil is a novel oncology product which comprises a combination of BioSilicon and the isotope 32Phosphorus, a proven anti-cancer therapeutic. The targeted and localised 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 *GLOBOCAN, there were over 230,000 new cases and nearly as many deaths from pancreatic cancer worldwide in 2002. Approximately 50 per cent 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 computerised Tomography scanning of the tumour size and overall survival, will be secondary endpoints. The trial is being conducted in both Europe and Asia with a second clinical centre at the Singapore General Hospital and the National Cancer Centre Singapore. The findings will provide a platform for further multicentre efficacy and safety trials.

Pancreatic cancer is the second clinical indication for BrachySil, currently in Phase 2b clinical trials for the treatment of inoperable primary liver cancer. A Phase 2a study in inoperable primary liver cancer was completed in July 2005 and showed BrachySilto be well tolerated. All patients experienced a decrease in the size of their tumours, with some experiencing complete tumour 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 CEO and Executive Chairman of pSivida Ltd, Dr Roger Brimblecombe.

"This trial expands our clinical development program for BrachySil our novel oncology product, into an additional solid tumour indication for which current therapies are very inadequate".

*GLOBOCAN is a worldwide database of cancer incidence and mortality rates.