Construction will enable pSivida to increase BrachySil production

Global nanotechnology company pSivida Limited has announced that it's UK manufacturing partner, Atomising Systems Ltd ("ASL"), has reached a key milestone in the manufacture of BrachySil, its lead product, by completing construction of a state of the art dedicated cleanroom facility to GMP specifications at its Sheffield plant in the United Kingdom. ASL is a world leader in high temperature atomising technology.

The milestone achievement will enable pSivida to increase BrachySil production in support of both larger clinical trials for advanced liver cancer and new Phase IIa trials in a second cancer indication planned for later this year. For future commercialisation, pSivida will use the dedicated facility to produce ultra-pure nano-structured BioSilicon microparticles doped with phosphorus: These microparticles are created using a specially developed melting process and water atomisation.

Following this process, the BioSilicon microparticles are activated to become BrachySil, i.e. the integral phosphorus is converted into its radioisotope form - 32-P - at AEA Technology QSA's Auriga Medical facility in Germany.

pSivida's Managing Director, Gavin Rezos, said, "The development of this facility is important in the future development of BrachySil as a solid tumor cancer therapy. It forms one piece of the overall process for getting this exciting product through clinical trials to market and scale up production once regulatory approval is received."

BrachySil has recently shown excellent results in Phase II clinical trials as a radiotherapy for the treatment of inoperable primary liver cancer, where it is delivered directly into tumors without surgery, a procedure known as brachytherapy.

The trials have shown no product-related side effects while also demonstrating significant tumor regression; up to 100% in some cases for smaller tumors. The ability of BrachySil to remain at the injection site is another significant outcome of the trial.

pSivida expects to begin a dose-profiling study during 2005 and pivotal registration trials during 2005. These multi-center trials will involve patients in Asia, Europe and the US and will provide data to support planned registration of BrachySil in 2007 as an approved treatment for primary liver cancer.

pSivida also plans to expand the use of BrachySil as a treatment for a wider range of solid tumor indications. A Phase IIa clinical trial is scheduled to commence for a second cancer indication within the next year.

The brachytherapy market is currently over US$600 million per annum and is expected to exceed US$1 billion within the next few years (Bio-Tech Systems). BrachySil has the potential to significantly expand the current market size through its application to other cancers.