pSivida Reaches Milestone in Production Scale-up Process for BrachySil(tm) Cancer Therapy

New facility will provide ultra-pure BioSilicon(tm) microparticles for future BrachySil(tm) production

04-Apr-2005

pSivida Limited announced that it's UK manufacturing partner, Atomising Systems Ltd ("ASL"), has reached a key milestone in the manufacture of BrachySil(tm), 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.

The milestone achieved will enable pSivida to increase BrachySil(tm) 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(tm) microparticles doped with phosphorus. These microparticles are created using a specially developed melting process and water atomisation. Following this process, the BioSilicon(tm) microparticles are activated to become BrachySil(tm), i.e. the integral phosphorus is converted into its radioisotope form - 32-P - at AEA Technology QSA's Auriga Medical(tm) facility in Germany.

BrachySil(tm) 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(tm) to remain at the injection site is another significant outcome of the trial.

https://www.bionity.com/en/news/44805/psivida-reaches-milestone-in-production-scale-up-process-for-brachysil-tm-cancer-therapy.html