UK company Atomising Systems Ltd has completed construction of a cleanroom facility at its plant in Sheffeld, UK, that will be used to produce a delivery vehicle used in Brachysil, a candidate drug for liver cancer.
ASL has a partnership to produce the drug delivery vehicle, called BioSilicon, with nanotechnology company pSivida. The completion of the plant 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, and 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 new facility "forms one piece of the overall process for getting this product through clinical trials to market and scale-up production once regulatory approval is received."
BrachySil has recently shown promising results in Phase II clinical trials as a radiotherapy for the treatment of inoperable primary liver cancer, where it is delivered directly into tumours 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 tumours. The trial also demonstrated that BrachySil remains at the injection site and does not spread through the body, preventing the exposure of healthy tissues to the radiotherapy.
pSivida said it expects to begin both a dose-profiling study and pivotal registration trials during 2005, with a marketing application scheduled for 2007 as an approved treatment for primary liver cancer. A Phase IIa clinical trial is scheduled to commence for a second cancer indication within the next year.
The brachytherapy market is currently valued at over $600 million (€463m) per annum and is expected to exceed $1 billion within the next few years, according to market research firm Bio-Tech Systems.