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1. (WO2008031051) CLINICAL DIAGNOSIS OF HEPATIC FIBROSIS USING A NOVEL PANEL OF HUMAN SERUM PROTEIN BIOMARKERS
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2008/031051 International Application No.: PCT/US2007/077911
Publication Date: 13.03.2008 International Filing Date: 07.09.2007
IPC:
G01N 33/68 (2006.01) ,G01N 33/576 (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
68
involving proteins, peptides or amino acids
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
576
for hepatitis
Applicants:
UNITED THERAPEUTICS CORPORATION [US/US]; 1110 Spring Street Silver Spring, MD 20910, US (AllExceptUS)
GANGADHARAN, Bevin [GB/GB]; GB (UsOnly)
ZITZMANN, Nicole [DE/GB]; US (UsOnly)
DWEK, Raymond, A. [GB/GB]; US (UsOnly)
Inventors:
GANGADHARAN, Bevin; GB
ZITZMANN, Nicole; US
DWEK, Raymond, A.; US
Agent:
MAEBIUS, Stephen, B. ; Foley & Lardner LLP Washington Harbor 3000 K St, NW Suite 500 Washington, DC 20007, US
Priority Data:
60/842,98008.09.2006US
Title (EN) CLINICAL DIAGNOSIS OF HEPATIC FIBROSIS USING A NOVEL PANEL OF HUMAN SERUM PROTEIN BIOMARKERS
(FR) DIAGNOSTIC CLINIQUE D'UNE FIBROSE HÉPATIQUE EN UTILISANT UNE NOUVELLE NUMÉRATION GLOBULAIRE DE BIOMARQUEURS DE PROTÉINES DU SÉRUM HUMAIN
Abstract:
(EN) The inventors have proposed a novel panel of human serum protein biomarkers for diagnosing hepatic fibrosis and cirrhosis. Presently there is no reliable non-invasive way of assessing liver fibrosis. A 2D-P AGE based proteomics study was used to identify potential fibrosis biomarkers. Serum from patients with varying degrees of hepatic scarring induced by infection with the hepatitis C virus (HCV) was analysed. Several proteins associated with liver scarring and/or viral infection were identified. These proteins include the inter-α-trypsin inhibitor heavy chain H4 fragments, complement factor H-related protein 1, CD5L, Apo Ll, and β2GPI. Increased and decreased thiolester cleavage of a2M and Complement C3, respectively, was also detected. The concentrations of these novel biomarkers can be determined using an immunoassay where the concentrations would reflect the extent of fibrosis. A fibrosis scoring scale for each of the novel biomarkers is proposed. The additive result from the scores of all the novel biomarkers would give a more reliable indication of the degree of fibrosis rather than examining individual biomarkers.
(FR) L'invention concerne une nouvelle numération globulaire de biomarqueurs de protéines du sérum humain pour diagnostiquer une fibrose hépatique et une cirrhose. Actuellement, il n'y a pas de manière non invasive fiable pour évaluer une fibrose du foie. Une étude protéomique basée sur 2D-PAGE a été utilisée pour identifier des biomarqueurs de fibrose potentiels. Du sérum provenant de patients ayant des degrés variables de cicatrisation hépatique induite par infection avec le virus de l'hépatite C (HCV) a été analysé. Plusieurs protéines associées à une cicatrisation du foie et/ou une infection virale ont été identifiées. Ces protéines comprennent les fragments H4 de la chaîne lourde de l'inhibiteur de la trypsine inter-a, une protéine en rapport avec le facteur H de protéine 1, CD5L, Apo L1 et b2GPI. On a également détecté un clivage de thiolester augmenté et diminué de a2M et du complément C3, respectivement. Les concentrations de ces nouveaux biomarqueurs peuvent être déterminées en utilisant un immunoessai où les concentrations vont refléter l'étendue de la fibrose. Une échelle de quantification de fibrose pour chacun des nouveaux biomarqueurs est proposée. Le résultat supplémentaire provenant des scores de tous les nouveaux biomarqueurs va donner une indication plus fiable du degré de fibrose plutôt que d'examiner des biomarqueurs individuels.
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Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, 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, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, MT, NL, PL, PT, RO, SE, SI, SK, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)