Phase I/III study of rVIII-SingleChain (CSL Behring) for Haemophilia A begins - 26-Feb-2012

Screening has begun in the AFFINITY clinical trial program for rVIII-SingleChain (rFVIII or recombinant coagulation single-chain factor VIII), from CSL Behring. The rVIII-SingleChain is a novel molecule being studied for the treatment of Haemophilia A. This Phase I/III study examines the crossover safety, efficacy and pharmacokinetics of rVIII-SingleChain compared with recombinant human antihemophilic factor VIII (octocog alpha). In Part 1 of the study, subjects will receive a single infusion of 50 IU/kg of octocog alpha followed by a single infusion of 50 IU/kg. In Parts 2 and 3 of the study, subjects will receive infusions of rVIII-SingleChain to prevent and treat bleeding, at a dose and frequency determined by their study doctor based on the subject's underlying bleeding phenotype. Recombinant single-chain factor VIII consists of two linked protein chains – a heavy one and a light one, which can dissociate. The rVIII-SingleChain uses a strong, covalent bond that connects the light and heavy chains, increasing molecular integrity, resulting in a product that is more stable than currently available FVIII products. This should also play an important role in the physiological activity and clearance of FVIII and has been shown to have an influence on the presentation of FVIII to the immune system.