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Baxter International Inc. (NYSE:BAX) today announced it has submitted an Investigational New Drug (IND) application for its investigational hemophilia A treatment BAX 855 with the U.S. Food and Drug Administration, following positive results from a Phase I trial. BAX 855 is a full-length longer-acting recombinant factor VIII (rFVIII) that was developed to increase the half-life of ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] – the most widely chosen rFVIII in the world. Baxter expects to start enrollment of adult patients in its Phase II/III study in the first quarter of 2013.
''With our focus on the needs of the hemophilia patient community, Baxter screened more than 100 molecules over several years and has selected one that has the potential to maintain the safety profile and meaningfully extend the half-life of ADVATE to allow for less frequent dosing. Importantly, BAX 855 is the only longer-acting rFVIII in development that is based on a treatment with nearly a decade of patient experience,'' said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter’s BioScience business.
A Phase I prospective, open-label trial assessing the safety, tolerability and pharmacokinetics of BAX 855 was conducted in 19 previously treated patients age 18 years or older with severe hemophilia A who completed the trial. The half-life (measuring the duration of activity of the drug in the body) of BAX 855 was approximately 1.5-fold higher compared to ADVATE. A longer half-life was achieved in all patients in the study using BAX 855, no patients developed inhibitors to either base molecule, BAX 855 or PEG, and no patients had allergic reactions. Eleven adverse events were reported in eight patients across both treatment arms, but none was serious, treatment-related or resulted in withdrawal from the study.
''Efficacy and safety remain the primary goals for choosing a therapy,'' said David Bevan, M.D., St. Thomas Hospital, London, UK. ''This Phase I study suggests that BAX 855 retains the underlying attributes of ADVATE and has the potential for less frequent dosing, creating a potential new option for hemophilia A patients.''