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Feasibility


For the development of a new concept for the treatment of severe persistent food allergies based on recombinant hypo-allergens and to be successful within the time frame offered by FP7, the chosen approach should be simple. Some foods have at least three major allergens. This is true for most severe allergies to peanut and tree nuts and in these cases multiple recombinant allergens would be needed. The best prospects for reaching clinical testing at Phase II level are treatments targeting food allergies that are dominated by a single major allergen.



In the context of this proposal we focus on IgE-mediated food hypersensitivity, hereafter referred to as food allergy. The only available treatment for food allergy is avoidance, in conjunction with rescue medication in case of accidental exposure. Hidden allergens in composite foods or unwanted contaminations and occasional poor adherence to dietary restrictions make avoidance difficult and ineffective. Most food allergies are chronic life-long diseases that are potentially life-threatening. It is the main cause of emergency hospital ward visits for anaphylaxis. Food allergy is estimated to affect around 10 million EU citizens, and the threat of severe anaphylaxis has great impact on the quality of life of patients and their relatives. A curative treatment for food allergy is the only way to change this situation. Allergen-specific immunotherapy (SIT) is the only treatment available that comes close to a cure by targeting the immunological basis of the disease. During classical SIT allergic patients receive monthly injections with allergen extract for three to five years. It is a successful treatment for insect venom allergies and for respiratory allergies like rhino-conjunctivitis to pollen and house dust mite. Despite that almost 95% of the market for treatment of allergic diseases is covered by symptomatic drugs. The burden of monthly injections for prolonged periods and the variable quality of products based on biological extracts provide the basis for the current niche position of SIT. For food allergy, SIT is not used at all. Attempts to treat food allergies by SIT have failed because anaphylactic side-effects were too numerous and severe.