04 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Australia-based CSL Behring achieved improved pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) over octocog alfa (the comparator). It also demonstrated a safety and efficacy profile that supports advancement to late-stage clinical development.
CSL Behring, in collaboration with its parent company, CSL, is developing rVIII-SingleChain for the treatment of hemophilia A as part of the Affinity clinical trial program.
"These data are promising and suggest that the recombinant single-chain design for Factor VIII may help address the need for a hemophilia A treatment with a longer half-life," said Professor Ingrid Pabinger-Fasching of the Medical University of Vienna, Austria. "A treatment with an improved half-life has the potential to increase the quality of life for those with severe hemophilia A by reducing the number of factor VIII protein infusions required to restore normal blood clotting."
The CSL Behring rVIII-SingleChain design uses a strong, covalent bond shown to improve the stability and half-life of factor VIII (FVIII). The investigational treatment is currently being studied in a phase III trial.
"As part of our commitment to developing effective therapies to treat hemophilia, we sought to develop a novel recombinant single-chain Factor VIII design that improves the stability and half-life of factor VIII," said Dr Russell Basser, senior VP, Global Clinical R&D, CSL. "We are encouraged by these clinical results and very pleased that our investigation of rVIII-SingleChain molecule has progressed to phase III."