Presentation and Publication of Research at AAAAI Demonstrates EPITTM's Ability to rebalance the Immune System
and Induce a Disease-Modifying Effect
BAGNEUX, France, March 4, 2014 - DBV Technologies (Euronext: DBV - ISIN: FR0010417345), creator of Viaskin®, a new paradigm for the treatment of allergies, today announced that further preclinical data supporting Epicutaneous Immunotherapy's (EPITTM) immune-modulating long-lasting and protective effect were presented at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) and recently published in the Journal of Allergy and Clinical Immunology ("State of the art on food allergen immunotherapy: oral, sublingual, and epicutaneous"; Stacie M. Jones, A. Wesley Burks, and Christophe Dupont; JACI, February 2014, Volume 133, Number 2).
Pierre-Henri Benhamou, Chairman & CEO of DBV Technologies, said: "DBV is developing Viaskin, a first-in-class treatment for IgE-mediated allergies, which will probably revolutionize the way allergic diseases are currently treated. Viaskin's excellent acceptability, efficacy and safety profile, which does not require oral intake of the offending allergen will help to treat food allergic patients with a pharmaceutical treatment that is safe even for the most vulnerable and the youngest patients. Dr. Benhamou concluded "In our effort to continue expanding our understanding of EPIT's mechanism of action, these new data will extend our knowledge on the long term efficacy and tolerance induction process. We are especially proud of the Dr. Mondoulet's findings on epigenetic level and of the report from Dr. Cecilia Berin, worldwide recognize searcher in allergy from Mount Sinai Hospital, NY, who brings new evidence of the long term efficacy of Viaskin."
Summary from AAAAI 2014 Presentations and Recent Scientific Publications
Epicutaneous immunotherapy (EPIT) will allow to treat safely life-threatening allergies in highly sensitive patient population, such as the pediatric patients. Recent preclinical data and scientific publications suggest:
EPITTM delivers a powerful and long lasting immune-modulating and protective effect, directly in the genome evidenced through epigenetic changes observed by Dr. Mondoulet. This mechanism results to a long term protection and prevent new sensitization via a T cell regulatory (Treg) in an animal model. Compared to SLIT (sublingual immune therapy), EPIT induces a larger and stronger expression of T cell regulatory (Treg). In another study presented at San Diego, Tregs induced by EPIT have a digestive tropism explaining the effectiveness of EPIT in food allergy.
A recent scientific publication in the Journal of Allergy and Clinical Immunology (JACI), "State of the art on food allergen immunotherapy: Oral, sublingual, and epicutaneous", also recently underlined the novel and differentiated cellular mechanism of EPITTM in comparison with the other methods of desensitization.
While the clinical program is ongoing, DBV continues to support its scientific research in order to fully elucidate the underlying immune mechanisms of food allergy and of tolerance induction.
About DBV Technologies
DBV Technologies is opening up a decisive new approach to the treatment of allergy - a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people and thus constitute a major unmet medical need. DBV Technologies has developed a unique, proprietary, worldwide-patented technology for administering an allergen to intact skin and avoiding massive transfer to the blood. The Viaskin® technology combines efficacy and safety as part of a treatment that seeks to improve the patient's tolerability of peanut and thus considerably lower the risk of a systemic, allergic reaction in the event of accidental exposure to the allergen. The company's significant development program has taken this revolutionary method through to the industrial stage in Europe, initially. The product's clinically proven safety of use enables the application of effective desensitization techniques (the efficacy of which is acknowledged worldwide) in the most severe forms of the allergy. DBV Technologies is focusing on food allergies (milk and peanut) for which there are currently no effective treatments. It has developed two products: Viaskin® Peanut and Viaskin® Milk. The clinical development program for Viaskin® Peanut has received Fast Track designation from the US Food and Drug Administration. The company will subsequently develop a Viaskin® patch for young children with house dust mite allergy - a true public health issue because this pathology is one of the main risk factors for childhood asthma. DBV Technologies shares are traded on segment C of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345).
For more information on DBV Technologies, please visit our website: www.dbv-technologies.com
CAUTION: Viaskin® is not approved for sale in the USA.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Company's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Company may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Company cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. DBV technologies' business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.
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