RVIII-SingleChain: Phase I data

CSL's CSL Behring subsidiary reported data from 27 patients with severe hemophilia A in the first part of the 3-part, open-label, crossover, international Phase I/III AFFINITY trial showing that rVIII-SingleChain has a longer half-life and lower clearance compared to Advate octocog alfa. CSL Behring said the pharmacokinetic data support twice-weekly dosing for prophylaxis of bleeding in patients with hemophilia A. The compound was well tolerated. Subjects received a single infusion of 50 IU/kg Advate followed by a single infusion of 50 IU/kg rVIII-SingleChain. There was a 4-day minimum washout phase between treatments. Data were presented at the International Society on Thrombosis and Hemostasis meeting in Amsterdam. ...