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1. WO2008031051 - CLINICAL DIAGNOSIS OF HEPATIC FIBROSIS USING A NOVEL PANEL OF HUMAN SERUM PROTEIN BIOMARKERS

Publication Number WO/2008/031051
Publication Date 13.03.2008
International Application No. PCT/US2007/077911
International Filing Date 07.09.2007
IPC
G01N 33/68 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48Biological material, e.g. blood, urine; Haemocytometers
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
68involving proteins, peptides or amino acids
G01N 33/576 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48Biological material, e.g. blood, urine; Haemocytometers
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
53Immunoassay; Biospecific binding assay; Materials therefor
576for hepatitis
CPC
G01N 2333/775
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
2333Assays involving biological materials from specific organisms or of a specific nature
435from animals; from humans
775Apolipopeptides
G01N 2800/085
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
2800Detection or diagnosis of diseases
08Hepato-biliairy disorders other than hepatitis
085Liver diseases, e.g. portal hypertension, fibrosis, cirrhosis, bilirubin
G01N 33/576
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
48Biological material, e.g. blood, urine
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
53Immunoassay; Biospecific binding assay; Materials therefor
576for hepatitis
G01N 33/5767
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
48Biological material, e.g. blood, urine
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
53Immunoassay; Biospecific binding assay; Materials therefor
576for hepatitis
5767non-A, non-B hepatitis
G01N 33/6893
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
48Biological material, e.g. blood, urine
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
68involving proteins, peptides or amino acids
6893related to diseases not provided for elsewhere
Y10S 436/811
YSECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
10TECHNICAL SUBJECTS COVERED BY FORMER USPC
STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
436Chemistry: analytical and immunological testing
811Test for named disease, body condition or organ function
Applicants
  • UNITED THERAPEUTICS CORPORATION [US]/[US] (AllExceptUS)
  • GANGADHARAN, Bevin [GB]/[GB] (UsOnly)
  • ZITZMANN, Nicole [DE]/[GB] (UsOnly)
  • DWEK, Raymond, A. [GB]/[GB] (UsOnly)
Inventors
  • GANGADHARAN, Bevin
  • ZITZMANN, Nicole
  • DWEK, Raymond, A.
Agents
  • MAEBIUS, Stephen, B.
Priority Data
60/842,98008.09.2006US
Publication Language English (EN)
Filing Language English (EN)
Designated States
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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