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1. (WO2018127920) THERAPEUTIC REGIMEN FOR THE TREATMENT OF FABRY USING STABILIZED ALPHA-GALACTOSIDASE
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Pub. No.: WO/2018/127920 International Application No.: PCT/IL2018/050018
Publication Date: 12.07.2018 International Filing Date: 05.01.2018
IPC:
A61K 38/47 (2006.01) ,C12N 9/24 (2006.01)
Applicants: PROTALIX LTD.[IL/IL]; 2 Snunit Street Science Park 2010000 Carmiel, IL
Inventors: ALMON, Einat; IL
CHERTKOFF, Raul; IL
ALON, Sari; IL
SHAALTIEL, Yoseph; IL
Agent: EHRLICH, Gal; G. E. EHRLICH (1995) LTD. 11 Menachem Begin Road 5268104 Ramat Gan, IL
EHRLICH, Gal; IL
WATERMAN, Hadassa; IL
MELNICK, Geoffrey, L.; IL
Priority Data:
62/442,53705.01.2017US
Title (EN) THERAPEUTIC REGIMEN FOR THE TREATMENT OF FABRY USING STABILIZED ALPHA-GALACTOSIDASE
(FR) RÉGIME THÉRAPEUTIQUE POUR LE TRAITEMENT DE LA MALADIE DE FABRY À L'AIDE D'UNE ALPHA-GALACTOSIDASE STABILISÉE
Abstract: front page image
(EN) Methods of treating Fabry disease via administration of stabilized plant recombinant human alpha galactosidase protein comprising at least two alpha-galactosidase monomers being covalently linked to one another via a linking moiety, and unit dosages of protein are disclosed herein. The disclosed protocols are safe, have greater than 2 week intervals between administrations and exhibit important improvement in patient's disease parameters, in terms of reduced Gb3 accumulation, pain and GI parameters, kidney and cardiac stabilization in the clinical setting.
(FR) L'invention concerne des méthodes de traitement de la maladie de Fabry par administration d'une protéine alpha-galactosidase humaine recombinée stabilisée comprenant au moins deux monomères alpha-galactosidase liés l'un à l'autre par covalence par l'intermédiaire d'un fragment de liaison, et des doses unitaires de protéine. Les protocoles décrits sont sans danger, ont des intervalles d'administration de plus de 2 semaines et sont à l'origine d'une amélioration importante des paramètres pathologiques du patient, en termes de réduction de l'accumulation de Gb3, de douleur et paramètres GI, et de stabilisation des fonctions rénale et cardiaque dans le cadre clinique.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)