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FAST towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies.doc

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FAST towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies

Zuidmeer-Jongejanetal.ClinicalandTranslationalAllergy2012,2:5 /content/2/1/5 REVIEW OpenAccess FAST:towardssafeandeffectivesubcutaneous immunotherapyofpersistentlife-threatening foodallergies LaurianZuidmeer-Jongejan1,18*,MontserratFernandez-Rivas2,LarsKPoulsen3,AngelaNeubauer4,JuanAsturias5, LarsBlom3,JoyceBoye6,CarstenBindslev-Jensen7,MichaelClausen8,RosaFerrara9,PaulaGarosi10,HansHuber4, BettinaMJensen3,StefKoppelman11,MarekLKowalski12,AnnaLewandowska-Polak12,BirgitLinhart13, BernardMaillere14,AdrianoMari9,AlbertoMartinez5,ClareENMills10,15,ClaudioNicoletti10,Dirk-JanOpstelten11, NikosGPapadopoulos16,AntonioPortoles2,NeilRigby10,EnricoScala9,HeidiJSchnoor3, SigurveigTSigurdardottir8,GeorgeStavroulakis16,FrankStolz4,InesSwoboda13,RudolfValenta13, RobvandenHout11,SergeAVersteeg1,MarianneWitten3andRonaldvanRee1,17 Abstract TheFASTproject(FoodAllergySpecificImmunotherapy)aimsatthedevelopmentofsafeandeffectivetreatment offoodallergies,targetingprevalent,persistentandsevereallergytofishandpeach.Classicalallergen-specific immunotherapy(SIT),usingsubcutaneousinjectionswithaqueousfoodextractsmaybeeffectivebuthasproven tobeaccompaniedbytoomanyanaphylacticside-effects.FASTaimstodevelopasafealternativebyreplacing foodextractswithhypoallergenicrecombinantmajorallergensastheactiveingredientsofSIT.Bothseverefishand peachallergyarecausedbyasinglemajorallergen,parvalbumin(Cypc1)andlipidtransferprotein(Prup3), respectively.Twoapproachesarebeingevaluatedforachievinghypoallergenicity,i.e.site-directedmutagenesisand chemicalmodification.ThemostpromisinghypoallergenswillbeproducedunderGMPconditions.Afterpre- clinicaltesting(toxicologytestingandefficacyinmousemodels),SCITwithalum-absorbedhypoallergenswillbe evaluatedinphaseI/IIaandIIbrandomizeddouble-blindplacebo-controlled(DBPC)clinicaltrials,withtheDBPC foodchallengeasprimaryread-out.Tounderstandtheunderlyingimmunemechanismsindepthserologicaland cellularimmuneanalyseswillbeperformed,allowingidentificationofnovelbiomarkersformonitor