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1. (WO2019050458) IMPROVED IMMUNOTHERAPY
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Pub. No.: WO/2019/050458 International Application No.: PCT/SE2018/050893
Publication Date: 14.03.2019 International Filing Date: 06.09.2018
IPC:
G01N 33/564 (2006.01) ,A61K 31/592 (2006.01) ,A61K 31/593 (2006.01) ,A61K 39/00 (2006.01) ,A61P 3/10 (2006.01) ,A61K 38/51 (2006.01) ,G01N 33/15 (2006.01) ,G01N 33/569 (2006.01)
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33
Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48
Biological material, e.g. blood, urine; Haemocytometers
50
Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
53
Immunoassay; Biospecific binding assay; Materials therefor
564
for pre-existing immune complex or autoimmune disease
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
59
Compounds containing 9,10-seco-cyclopenta[a]hydro- phenanthrene ring systems
592
9,10-Secoergostane derivatives, e.g. ergocalciferol, vitamin D2
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
59
Compounds containing 9,10-seco-cyclopenta[a]hydro- phenanthrene ring systems
593
9,10-Secocholestane derivatives, e.g. cholecalciferol, vitamin D3
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39
Medicinal preparations containing antigens or antibodies
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3
Drugs for disorders of the metabolism
08
for glucose homeostasis
10
for hyperglycaemia, e.g. antidiabetics
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43
Enzymes; Proenzymes; Derivatives thereof
51
Lyases (4)
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33
Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
15
Medicinal preparations
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33
Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48
Biological material, e.g. blood, urine; Haemocytometers
50
Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
53
Immunoassay; Biospecific binding assay; Materials therefor
569
for micro-organisms, e.g. protozoa, bacteria, viruses
Applicants:
DIAMYD MEDICAL AB [SE/SE]; Kungsgatan 29 111 56 Stockholm, SE
Inventors:
LUDVIGSSON, Johnny; SE
CASAS, Rosaura; SE
HANNELIUS, Ulf; SE
LINDQVIST, Anton; SE
ESSEN-MÖLLLER, Anders; SE
Agent:
ZACCO SWEDEN AB; P.O. Box 5581 Valhallavägen 117N 114 85 Stockholm, SE
Priority Data:
1751091-808.09.2017SE
1850017-307.01.2018SE
Title (EN) IMPROVED IMMUNOTHERAPY
(FR) IMMUNOTHÉRAPIE AMÉLIORÉE
Abstract:
(EN) The invention relates to a method for assessing the efficacy of an immunotherapy comprising administration of GAD to a patient, comprising the following steps: measuring at least one of GADA IgG subclass distribution; GADA levels; distribution of cytokines secreted from lymphocytes; and lymphocyte proliferation in presence of GAD or CD3/CD28 beads; in a first blood, plasma or serum sample obtained from said patient at a first point in time and in a second blood, plasma or serum sample obtained from said patient at a later point in time; and comparing the so obtained measurements. The invention also relates to novel administration regimens of GAD in treatment or prevention of type 1 diabetes, that may include administration by injection into a lymph node, oral administration of vitamin D and/or an assessment of efficacy according to the above methodology followed by an adjustment of dosage and/or administration route based on said assessment.
(FR) La présente invention concerne un procédé d’évaluation de l’efficacité d’une immunothérapie comprenant l’administration de GAD à un patient, comprenant les étapes suivantes : mesure de la distribution d’au moins l’un parmi la sous-classe d’IgG GADA ; des taux de GADA ; de la distribution de cytokines sécrétées par des lymphocytes ; et de la prolifération de lymphocytes en présence de billes de GAD ou CD3/CD28 ; dans un premier échantillon de sang, de plasma ou de sérum obtenu à partir dudit patient à un premier temps et dans un deuxième échantillon de sang, de plasma ou de sérum obtenu à partir dudit patient à un temps ultérieur ; et comparaison des mesures obtenues ainsi. L’invention concerne en outre de nouveaux régimes posologiques de GAD dans le traitement ou la prévention du diabète de type 1, qui peuvent comprendre l’administration par injection dans un ganglion lymphatique, l’administration orale de vitamine D et/ou une évaluation de l’efficacité selon la méthodologie ci-dessus suivie d’un ajustement de la dose et/ou de la voie d’administration sur la base de ladite évaluation.
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)