pSivida completes manufacturing infrastructure for BrachySil cancer therapy
Global nanotechnology company pSivida has announced that it's manufacturing partner QSA has completed the construction and validation of a state-of-the-art cleanroom facility, dedicated to the supply of pSivida's lead cancer therapy BrachySil, at QSA's Auriga Medical facility in Braunschweig, Germany.
Global nanotechnology company pSivida has announced that it's manufacturing partner QSA has completed the construction and validation of a state-of-the-art cleanroom facility, dedicated to the supply of pSivida's lead cancer therapy BrachySil, at QSA's Auriga Medical facility in Braunschweig, Germany.
This cGMP facility will fulfil the final process in the manufacture of BrachySil for future clinical and commercial use, and represents the crucial final stage in establishing the manufacturing and supply infrastructure to support BrachySil as it advances through clinical trials towards the market.
BrachySil (32-P BioSilicon) has shown good results in Phase IIa clinical trials as a radiotherapy for the treatment of inoperable primary liver cancer, where it is delivered directly into the tumors without surgery, a procedure known as brachytherapy. pSivida is currently preparing to begin Phase IIb dose-profiling studies with BrachySil in this indication and expects to treat its first patient before the end of 2005.
The company is also planning Phase IIa trials with BrachySil to evaluate its safety and efficacy in patients suffering from pancreatic cancer. This trial is also on schedule to begin in late 2005.
pSivida and QSA entered into an extendable three-year manufacturing agreement for BrachySil in March 2004. Under the terms of the agreement, QSA's specialist brachytherapy and radioimmunotherapy business Auriga Medical was to design and construct a dedicated facility, optimised for the processing of BrachySil (32-P BioSilicon). Auriga Medical will also manage the supply logistics for clinical and commercial use.
'The completion of this facility marks a significant step forward towards commercialising BrachySil,' said pSivida's managing director, Gavin Rezos. 'All key steps and facilities involved in the BrachySil manufacturing process are now operating to the essential GMP requirements necessary for regulatory approval. We are now in a very good position to rapidly advance our clinical development and commercialisation programme.'