SR Pharma Establishes GMP Production with Partners for RNAi Therapeutic Product
News Jun 16, 2006
SR Pharma plc has announced that its operating subsidiary Atugen AG, has established collaborations with Genzyme, BioSpring and OctoPlus to manufacture and formulate its lead RNAi therapeutic product Atu027 to GMP standards.
Atu027 is a siRNA based anti-cancer drug, that is on track to enter initial clinical trials in the first half of 2007.
In combination, these suppliers will provide product for the forthcoming pharmacokinetic and toxicology studies as well as the planned clinical studies.
Completion of the pre-clinical trials of Atu027 later this year will provide the basis for the Company to progress third party out-licensing deals for the general RNAi delivery system (AtuPLEX) used in Atu027 as well as permitting SR Pharma to start the first phase I clinical trial of Atu027 during the first half of 2007.
Iain Ross, Executive Chairman of SR Pharma, stated, "Atugen is rapidly moving forward towards testing the clinical applications of Atu027 and towards delivering some potential commercial out-licensing applications for its drug delivery system AtuPLEX."
"Consultation with the German regulatory agency for drug approval (BfArM) will be held shortly to define the final steps before entering the clinic with Atu027."