Baxter completes patient enrollment in phase III trial of BAX 855, extended half-life rFVIII to treat haemophilia A

Baxter International Inc. has completed enrollment in its phase III clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) treatment for haemophilia A. The ongoing trial is aimed at assessing the efficacy of the compound in reducing annualized bleed rates (ABR) in both prophylaxis and on-demand treatment schedules, and will also evaluate its safety and pharmacokinetic profile.BAX 855 was designed based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product with 10 years of real-world experience. The BAX 855 molecule was modified with PEGylation technology designed to extend its duration of activity in the body."The BAX 855 development programme is a priority for Baxter as we evaluate the potential to provide an efficacious and safe treatment with an extended half-life for patients with hemophilia," said Anders Ullman, MD, Ph.D., vice president of global research and development in Baxter's BioScience business. "We are focused first and foremost on strategies to address optimal efficacy and minimize patients' bleeding episodes, while at the same time delivering on the convenience of less frequent dosing for this population with severe disease."The phase II/III multi-centre, open-label study called PROLONG-ATE is evaluating BAX 855 among 146 adult patients with previously-treated severe haemophilia A. Patients participating in PROLONG-ATE receive treatment twice weekly (45 IU/kg)...
Source: Medical Hemostat - Category: Technology Consultants Authors: Source Type: blogs