SR Pharma plc has announced the completion of initial toxicology studies for its RNAi product candidate Atu027. These studies were conducted in Basel, Switzerland by RCC, an independent contract research organisation.
The results confirmed that there was no local problem at the site of infusion with this systemically administered product.
Atu027 is a reconstituted lyophilised material that was tested in repeated 4-hour and 24-hour continuous intravenous infusions. The drug candidate was given every third day over a period of 15 days.
As a consequence, advanced toxicology programs with this lead product candidate will start at the end of November 2006.
The GMP manufacturing process has already been established and scale-up to provide sufficient material for further pre-clinical and clinical testing is underway.
Iain Ross, Chairman of SR Pharma, said, "The results of these pilot toxicology studies are very encouraging and confirm that we are well on track with the pre-clinical programme for our systemically delivered RNAi product candidate, Atu027. Human clinical trials with Atu027 in oncology indications are now expected to commence in mid 2007."