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DBV Technologies Forms Research Collaboration With Inserm To Develop Viaskin(R) For Refractory Hemophilia A Disease

BAGNEUX, France, Oct. 22, 2013 (GLOBE NEWSWIRE) -- DBV Technologies (Euronext:DBV) (ISIN: FR0010417345), creator of Viaskin®, a new standard in the treatment of allergies, announced today that it has entered into a research collaboration with Institut national de la Santé et de la recherche médicale, Inserm and Inserm Transfert, to investigate the effect of epicutaneous delivery of recombinant Factor VIII (FVIII) protein via Viaskin in an animal model of hemophilia A. DBV and Inserm are teaming up to combine the Viaskin® technology and a world-class expertise in hemophilia A to develop a potential standard of care for refractory hemophilia A patients, by providing a cost-effective, and non-invasive treatment.

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."

Dr. Pierre-Henri Benhamou, Chairman and CEO of DBV Technologies, said, " The establishment of a partnership with Dr. Sebastien Lacroix-Desmazes and Inserm, with their extensive expertise in Hemophilia A, can potentially open a new path for Viaskin to become the future of hemophilia A treatment as a non-invasive, prophylactic alternative against an alloimmune response to therapeutic Factor VIII." Dr. Pierre-Henri Benhamou concluded: " This research should reinforce the relevance of the Viaskin® platform, as a technology enabling deep and durable modulation of inappropriate immune responses."

The protective effect conferred by the immunological response induced by epicutaneous immunotherapy using Viaskin® 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, DBV Technologies has developed a first-in-class approach to deliver antigens of choice to immuno-sensitized organisms as a method to induce antigen-specific tolerance, and in this case, tolerance to therapeutic FVIII in hemophilia A.

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