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Enrollment Complete for Baxter’s PROLONG-ATE Study

Last month, Baxter International, Inc., announced the completion of enrollment in its ongoing clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) therapy for treatment of patients with hemophilia A. The trial is 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 pharmacokinetics.


PROLONG-ATE is Baxter’s phase 3 multi-center study evaluating BAX 855 in 146 adult patients with previously-treated severe hemophilia A. Study subjects receive twice weekly infusions for six months. The primary endpoint of the study is the ABR during the treatment period. The study is also evaluating the safety and immunogenicity (capacity to trigger an inhibitor response) of the therapy when administered for prophylaxis or on-demand treatment regimens. Other outcome measures include number of infusions needed to treat bleeding episodes, time intervals between these episodes, pharmacokinetics and patient-reported outcomes. To date, no inhibitors or safety issues have been reported in the study.


“The BAX 855 development program 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, PhD, 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.”


Source: Baxter press release dated November 13, 2013