Dr. SÉbastien Lacroix-Desmazes, CNRS (Inserm Team UMRS 872, Immunopathology and Therapeutic Immuno-Intervention), said, "Preventing the immune response to therapeutic proteins upon induction of tolerance is the approach of choice for patients with hemophilia A. To date, the only strategy to induce tolerance to FVIII in patients who have developed anti-FVIII antibodies consists in flooding the immune system with enormous amounts of FVIII every day, for periods that can extend up to several months or years. This obviously faces issues with patients' compliance and treatment costs. Being able to induce FVIII-specific tolerance in hemophilia A patients using low doses of antigen, such as is the case with the Viaskin delivery system, would drastically improve the life of alloimmunized hemophilia A patients and solve a crucial societal burden."
The protective effect conferred by the immunological response induced by epicutaneous immunotherapy using ViaskinŽ will be tested at the humoral level, and is expected to induce tolerance to FVIII in mice with severe hemophilia A. The DBV-Inserm research collaboration will last 12 months. Different mice cohorts will be treated with Viaskin containing the FVIII protein versus placebo for 45 days. After 45 days, all mice will be subject to a protocol of replacement therapy for 4 weeks. The levels of anti-FVIII IgG and of FVIII inhibitors will then be assessed by immunological and functional assays. Various approaches have investigated treatments aimed at inducing tolerance to exogenous FVIII in hemophilic mice. Through the Viaskin platform,
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