pSivida moves to full development programme of pancreatic cancer product

pSivida Limited has announced that it has initiated a full development programme of its proprietary BrachySil product in a second key cancer indication. Development has commenced to evaluate the efficacy and safety of this novel brachytherapy product in pancreatic cancer, with the clinical programme scheduled to commence before the end of 2005.

Selection of this second key indication has resulted from significant independent market research and medical opinion leader feedback and therefore represents a judicious, robust and viable development option.

Pancreatic cancer is one of the most prevalent cancers with over 232,000 new cases on a global basis per annum (Globocan 2002 statistics) and approximately 60% of new cases occurring in the developed world. With an average five year survival of 4%, pancreatic cancer represents a significant unmet clinical need.

BrachySil is a micron-sized particle in which the isotope 32-phosphorus is immobilised. pSivida believes that this product is unique in that it demonstrates a very high degree of isotope retention, thus reducing the risk of radioactivity effecting healthy hepatic tissue or entering the circulation and causing systemic toxicity.

The clinical programme currently being conducted in primary liver cancer has provided significant data demonstrating the product’s safety, efficacy (up to 100% tumor regression in some cases for smaller tumors) and the ease of administration via a fine gauge needle injection procedure. The ability of BrachySil to remain at the injection site has been another significant outcome of the trials. Multi-centre pivotal registration trials are scheduled to commence during 2005 to provide data to support registration of BrachySil as an approved treaent for primary liver cancer.