TY - JOUR
T1 - FAST
T2 - Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies
AU - Zuidmeer-Jongejan, Laurian
AU - Fernandez-Rivas, Montserrat
AU - Poulsen, Lars K.
AU - Neubauer, Angela
AU - Asturias, Juan
AU - Blom, Lars
AU - Boye, Joyce
AU - Bindslev-Jensen, Carsten
AU - Clausen, Michael Stellian
AU - Ferrara, Rosa
AU - Garosi, Paula
AU - Huber, Hans
AU - Jensen, Bettina M
AU - Koppelman, Stef
AU - Kowalski, Marek L
AU - Lewandowska-Polak, Anna
AU - Linhart, Birgit
AU - Maillere, Bernard
AU - Mari, Adriano
AU - Martinez, Alberto
AU - Mills, Clare En
AU - Nicoletti, Claudio
AU - Opstelten, Dirk-Jan
AU - Papadopoulos, Nikos G
AU - Portoles, Antonio
AU - Rigby, Neil
AU - Scala, Enrico
AU - Schnoor, Heidi J
AU - Sigursdottir, Sigurveig
AU - Stavroulakis, Georg
AU - Stolz, Frank
AU - Swoboda, Ines
AU - Valenta, Rudolf
AU - van den Hout, Rob
AU - Versteeg, Serge A
AU - Witten, Marianne
AU - van Ree, Ronald
PY - 2012/3/9
Y1 - 2012/3/9
N2 - The FAST project (Food Allergy Specific Immunotherapy) aims at the development of safe and effective treatment of food allergies, targeting prevalent, persistent and severe allergy to fish and peach. Classical allergen-specific immunotherapy (SIT), using subcutaneous injections with aqueous food extracts may be effective but has proven to be accompanied by too many anaphylactic side-effects. FAST aims to develop a safe alternative by replacing food extracts with hypoallergenic recombinant major allergens as the active ingredients of SIT. Both severe fish and peach allergy are caused by a single major allergen, parvalbumin (Cyp c 1) and lipid transfer protein (Pru p 3), respectively. Two approaches are being evaluated for achieving hypoallergenicity, i.e. site-directed mutagenesis and chemical modification. The most promising hypoallergens will be produced under GMP conditions. After preclinical testing (toxicology testing and efficacy in mouse models), SCIT with alum-absorbed hypoallergens will be evaluated in phase I/IIa and IIb randomized double-blind placebo-controlled (DBPC) clinical trials, with the DBPC food challenge as primary read-out. To understand the underlying immune mechanisms in depth serological and cellular immune analyses will be performed, allowing identification of novel biomarkers for monitoring treatment efficacy. FAST aims at improving the quality of life of food allergic patients by providing a safe and effective treatment that will significantly lower their threshold for fish or peach intake, thereby decreasing their anxiety and dependence on rescue medication.
AB - The FAST project (Food Allergy Specific Immunotherapy) aims at the development of safe and effective treatment of food allergies, targeting prevalent, persistent and severe allergy to fish and peach. Classical allergen-specific immunotherapy (SIT), using subcutaneous injections with aqueous food extracts may be effective but has proven to be accompanied by too many anaphylactic side-effects. FAST aims to develop a safe alternative by replacing food extracts with hypoallergenic recombinant major allergens as the active ingredients of SIT. Both severe fish and peach allergy are caused by a single major allergen, parvalbumin (Cyp c 1) and lipid transfer protein (Pru p 3), respectively. Two approaches are being evaluated for achieving hypoallergenicity, i.e. site-directed mutagenesis and chemical modification. The most promising hypoallergens will be produced under GMP conditions. After preclinical testing (toxicology testing and efficacy in mouse models), SCIT with alum-absorbed hypoallergens will be evaluated in phase I/IIa and IIb randomized double-blind placebo-controlled (DBPC) clinical trials, with the DBPC food challenge as primary read-out. To understand the underlying immune mechanisms in depth serological and cellular immune analyses will be performed, allowing identification of novel biomarkers for monitoring treatment efficacy. FAST aims at improving the quality of life of food allergic patients by providing a safe and effective treatment that will significantly lower their threshold for fish or peach intake, thereby decreasing their anxiety and dependence on rescue medication.
U2 - 10.1186/2045-7022-2-5
DO - 10.1186/2045-7022-2-5
M3 - Journal article
C2 - 22409908
SN - 2045-7022
VL - 2
SP - 5
JO - Clinical and Translational Allergy
JF - Clinical and Translational Allergy
IS - 1
ER -