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Preclinical, Journal: Evaluation of factor VIII polysialylation: Identification of a longer-acting experimental therapy in mice and monkeys. (Pubmed Central) - Apr 22, 2020
The favorable profile and mechanism of this novel experimental therapeutic demonstrated all the requirements for an EHL-rFVIII candidate, and thus BAX 826 was entered into clinical assessment for the treatment of hemophilia A. SIGNIFICANCE STATEMENT: Prolongation of FVIII half-life aims to reduce the burden of prophylaxis and to improve treatment outcomes in patients with hemophilia. This study shows that polysialylation of PSArFVIII resulted in prolongations of rFVIII circulation time and procoagulant activity, together with a favorable non-clinical safety profile of the experimental therapeutic.
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Trial completion: BAX 826 Dose-Escalation Safety Study (clinicaltrials.gov) - Apr 19, 2017
P1, N=40, Completed,
This study shows that polysialylation of PSArFVIII resulted in prolongations of rFVIII circulation time and procoagulant activity, together with a favorable non-clinical safety profile of the experimental therapeutic. Recruiting --> Completed
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