Title:
METHODS OF ASSESSMENT OF DRUG METABOLIZING ENZYMES
Document Type and Number:
WIPO Patent Application WO2004069189
Kind Code:
A3
Abstract:
The invention provides a method for assessing drug metabolizing enzyme expression levels in whole blood. The invention enables prediction of the effectiveness or safety of a drug therapy by providing a measure of the drug metabolizing capability of the patient. The invention provides a method for detecting and quantifying CYP2D6 mRNA in biological samples, a multiplex assay for detecting SNPs of CYP2D6 gene, and a multiplex assay for detecting SNPs of NAT 1 and NAT2.
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Inventors:
BRANCH ROBERT A (US)
ROMKES MARJORIE (US)
ROMKES MARJORIE (US)
Application Number:
PCT/US2004/002941
Publication Date:
July 28, 2005
Filing Date:
February 04, 2004
Export Citation:
Assignee:
INNOVACEUTICALS INC (US)
BRANCH ROBERT A (US)
ROMKES MARJORIE (US)
BRANCH ROBERT A (US)
ROMKES MARJORIE (US)
International Classes:
C07H21/04; C12N9/02; C12Q1/68; G01N33/53; A61K; (IPC1-7): C12Q1/68
Domestic Patent References:
| WO2003008647A2 | 2003-01-30 | |||
| WO2000039332A1 | 2000-07-06 | |||
| WO2002099118A2 | 2002-12-12 | |||
| WO2000018800A1 | 2000-04-06 | |||
| WO2001049883A2 | 2001-07-12 | |||
| WO2002038589A2 | 2002-05-16 | |||
| WO2002057410A2 | 2002-07-25 | |||
| WO2004009760A2 | 2004-01-29 | |||
| WO2000024926A1 | 2000-05-04 | |||
| WO2002052044A2 | 2002-07-04 | |||
| WO2001079551A1 | 2001-10-25 |
Foreign References:
| EP0644267A2 | 1995-03-22 | |||
| EP1281755A2 | 2003-02-05 | |||
| US5844108A | 1998-12-01 | |||
| US20020128215A1 | 2002-09-12 | |||
| US20010034023A1 | 2001-10-25 |
Other References:
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; 1994, HAYASHI SHIN-ICHI ET AL: "Interindividual difference in expression of human Ah receptor and related P450 genes", XP002296569, Database accession no. PREV199497330207
LIN PINPIN ET AL: "Correlation between gene expression of aryl hydrocarbon receptor (AhR), hydrocarbon receptor nuclear translocator (Arnt), cytochromes P4501A1 (CYP1A1) and 1B1 (CYP1B1), and inducibility of CYP1A1 and CYP1B1 in human lymphocytes.", TOXICOLOGICAL SCIENCES, vol. 71, no. 1, January 2003 (2003-01-01), pages 20 - 26, XP002295844, ISSN: 1096-6080
MEYER U A ET AL: "MOLECULAR MECHANISMS OF GENETIC POLYMORPHISMS OF DRUG METABOLISM", ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, ANNUAL REVIEW INC., PALO ALTO, CA, US, vol. 37, 1997, pages 269 - 296, XP001073468, ISSN: 0362-1642
RAINEN L ET AL: "Stabilization of mRNA Expression in Whole Blood Samples", CLINICAL CHEMISTRY, AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY. WINSTON, US, vol. 48, no. 11, November 2002 (2002-11-01), pages 1883 - 1890, XP002273125, ISSN: 0009-9147
ENDRIZZI KARIN ET AL: "Discriminative quantification of cytochrome P4502D6 and 2D7/8 pseudogene expression by TaqMan real-time reverse transcriptase polymerase chain reaction", ANALYTICAL BIOCHEMISTRY, vol. 300, no. 2, 15 January 2002 (2002-01-15), pages 121 - 131, XP002318859, ISSN: 0003-2697
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; 2001, BERTINO J S: "Overview of the pharmacogenetics of drug disposition", XP002296570, Database accession no. PREV200200555700
CARCILLO JOSEPH A ET AL: "CYP2D6 mRNA expression in circulating peripheral blood mononuclear cells correlates with in vivo debrisoquine hydroxylase activity in extensive metabolizers", RESEARCH COMMUNICATIONS IN MOLECULAR PATHOLOGY AND PHARMACOLOGY, vol. 91, no. 2, 1996, pages 149 - 159, XP008043428, ISSN: 1078-0297
GERHOLD DAVID ET AL: "Monitoring expression of genes involved in drug metabolism and toxicology using DNA microarrays", PHYSIOLOGICAL GENOMICS, vol. 5, June 2001 (2001-06-01), pages 161 - 170, XP002318860, ISSN: 1094-8341
DEY APARAJITA ET AL: "Cytochrome P450 1A1 (CYP1A1) in blood lymphocytes: Evidence for catalytic activity and mRNA expression", LIFE SCIENCES, vol. 69, no. 4, 15 June 2001 (2001-06-15), pages 383 - 393, XP002318861, ISSN: 0024-3205
NGUYEN LINH T ET AL: "Detection of cytochrome P450 and other drug-metabolizing enzyme mRNAs in peripheral blood mononuclear cells using DNA arrays", DRUG METABOLISM AND DISPOSITION, vol. 28, no. 8, August 2000 (2000-08-01), pages 987 - 993, XP002318862, ISSN: 0090-9556
JANARDAN SRINIVAS K ET AL: "Selective expression of CYP3A5 and not CYP3A4 in human blood", PHARMACOGENETICS, vol. 6, no. 5, 1996, pages 379 - 385, XP008043370, ISSN: 0960-314X
LABUDA D ET AL: "RAPID DETECTION OF CYP1A1, CYP2D6, AND NAT VARIANTS BY MULTIPLEX POLYMERASE CHAIN REACTION AND ALLELE-SPECIFIC OLIGONUCLEOTIDE ASSAY", ANALYTICAL BIOCHEMISTRY, ACADEMIC PRESS, SAN DIEGO, CA, US, vol. 275, no. 1, 1 November 1999 (1999-11-01), pages 84 - 92, XP000884956, ISSN: 0003-2697
SEKINE AKIHIRO ET AL: "Identification of single-nucleotide polymorphisms (SNPs) of human N-acetyltransferase genes NAT1, NAT2, AANAT, ARD1, and L1CAM in the Japanese population", JOURNAL OF HUMAN GENETICS, vol. 46, no. 6, 2001, pages 314 - 319, XP002318863, ISSN: 1434-5161
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; July 2002 (2002-07-01), HIRATSUKA MASAHIRO: "Development of simplified and rapid detection assay for genetic polymorphisms influencing drug response and its clinical applications", XP002318867, Database accession no. PREV200200480046
FRETLAND ADRIAN J ET AL: "Functional characterization of human N-acetyltransferase 2 (NAT2) single nucleotide polymorphisms", PHARMACOGENETICS, vol. 11, no. 3, April 2001 (2001-04-01), pages 207 - 215, XP008043638, ISSN: 0960-314X
KITA T ET AL: "N-ACETYLTRANSFERAS 2 GENOTYPE CORRELATES WITH SULFASARAZINE PHARMACOKINETICS AFTER MULTIPLE DOSING IN HEALTHY JAPANESE SUBJECTS", BIOLOGICAL & PHARMACEUTICAL BULLETIN (OF JAPAN), PHARMACEUTICAL SOCIETY OF JAPAN, JP, vol. 24, no. 10, October 2001 (2001-10-01), pages 1176 - 1180, XP002951851, ISSN: 0918-6158
MEISEL P ET AL: "Prediction of metabolic activity from genotype: The gene-dose effect of N-acetyltransferase", THERAPEUTIC DRUG MONITORING, NEW YORK, NY, US, vol. 23, no. 1, February 2001 (2001-02-01), pages 9 - 14, XP009019868, ISSN: 0163-4356
HIRATSUKA M ET AL: "HIGH THROUGHPUT DETECTION OF DRUG-METABOLIZING ENZYME POLYMORPHISMS BY ALLELE-SPECIFIC FLUOROGENIC 5' NUCLEASE CHAIN REACTION ASSAY", BIOLOGICAL & PHARMACEUTICAL BULLETIN (OF JAPAN), PHARMACEUTICAL SOCIETY OF JAPAN, JP, vol. 23, no. 10, October 2000 (2000-10-01), pages 1131 - 1135, XP008026642, ISSN: 0918-6158
HUANG J X ET AL: "High-throughput genomic and proteomic analysis using microarray technology", CLINICAL CHEMISTRY, AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY. WINSTON, US, vol. 47, no. 10, October 2001 (2001-10-01), pages 1912 - 1916, XP002284875, ISSN: 0009-9147
LIN PINPIN ET AL: "Correlation between gene expression of aryl hydrocarbon receptor (AhR), hydrocarbon receptor nuclear translocator (Arnt), cytochromes P4501A1 (CYP1A1) and 1B1 (CYP1B1), and inducibility of CYP1A1 and CYP1B1 in human lymphocytes.", TOXICOLOGICAL SCIENCES, vol. 71, no. 1, January 2003 (2003-01-01), pages 20 - 26, XP002295844, ISSN: 1096-6080
MEYER U A ET AL: "MOLECULAR MECHANISMS OF GENETIC POLYMORPHISMS OF DRUG METABOLISM", ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, ANNUAL REVIEW INC., PALO ALTO, CA, US, vol. 37, 1997, pages 269 - 296, XP001073468, ISSN: 0362-1642
RAINEN L ET AL: "Stabilization of mRNA Expression in Whole Blood Samples", CLINICAL CHEMISTRY, AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY. WINSTON, US, vol. 48, no. 11, November 2002 (2002-11-01), pages 1883 - 1890, XP002273125, ISSN: 0009-9147
ENDRIZZI KARIN ET AL: "Discriminative quantification of cytochrome P4502D6 and 2D7/8 pseudogene expression by TaqMan real-time reverse transcriptase polymerase chain reaction", ANALYTICAL BIOCHEMISTRY, vol. 300, no. 2, 15 January 2002 (2002-01-15), pages 121 - 131, XP002318859, ISSN: 0003-2697
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; 2001, BERTINO J S: "Overview of the pharmacogenetics of drug disposition", XP002296570, Database accession no. PREV200200555700
CARCILLO JOSEPH A ET AL: "CYP2D6 mRNA expression in circulating peripheral blood mononuclear cells correlates with in vivo debrisoquine hydroxylase activity in extensive metabolizers", RESEARCH COMMUNICATIONS IN MOLECULAR PATHOLOGY AND PHARMACOLOGY, vol. 91, no. 2, 1996, pages 149 - 159, XP008043428, ISSN: 1078-0297
GERHOLD DAVID ET AL: "Monitoring expression of genes involved in drug metabolism and toxicology using DNA microarrays", PHYSIOLOGICAL GENOMICS, vol. 5, June 2001 (2001-06-01), pages 161 - 170, XP002318860, ISSN: 1094-8341
DEY APARAJITA ET AL: "Cytochrome P450 1A1 (CYP1A1) in blood lymphocytes: Evidence for catalytic activity and mRNA expression", LIFE SCIENCES, vol. 69, no. 4, 15 June 2001 (2001-06-15), pages 383 - 393, XP002318861, ISSN: 0024-3205
NGUYEN LINH T ET AL: "Detection of cytochrome P450 and other drug-metabolizing enzyme mRNAs in peripheral blood mononuclear cells using DNA arrays", DRUG METABOLISM AND DISPOSITION, vol. 28, no. 8, August 2000 (2000-08-01), pages 987 - 993, XP002318862, ISSN: 0090-9556
JANARDAN SRINIVAS K ET AL: "Selective expression of CYP3A5 and not CYP3A4 in human blood", PHARMACOGENETICS, vol. 6, no. 5, 1996, pages 379 - 385, XP008043370, ISSN: 0960-314X
LABUDA D ET AL: "RAPID DETECTION OF CYP1A1, CYP2D6, AND NAT VARIANTS BY MULTIPLEX POLYMERASE CHAIN REACTION AND ALLELE-SPECIFIC OLIGONUCLEOTIDE ASSAY", ANALYTICAL BIOCHEMISTRY, ACADEMIC PRESS, SAN DIEGO, CA, US, vol. 275, no. 1, 1 November 1999 (1999-11-01), pages 84 - 92, XP000884956, ISSN: 0003-2697
SEKINE AKIHIRO ET AL: "Identification of single-nucleotide polymorphisms (SNPs) of human N-acetyltransferase genes NAT1, NAT2, AANAT, ARD1, and L1CAM in the Japanese population", JOURNAL OF HUMAN GENETICS, vol. 46, no. 6, 2001, pages 314 - 319, XP002318863, ISSN: 1434-5161
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; July 2002 (2002-07-01), HIRATSUKA MASAHIRO: "Development of simplified and rapid detection assay for genetic polymorphisms influencing drug response and its clinical applications", XP002318867, Database accession no. PREV200200480046
FRETLAND ADRIAN J ET AL: "Functional characterization of human N-acetyltransferase 2 (NAT2) single nucleotide polymorphisms", PHARMACOGENETICS, vol. 11, no. 3, April 2001 (2001-04-01), pages 207 - 215, XP008043638, ISSN: 0960-314X
KITA T ET AL: "N-ACETYLTRANSFERAS 2 GENOTYPE CORRELATES WITH SULFASARAZINE PHARMACOKINETICS AFTER MULTIPLE DOSING IN HEALTHY JAPANESE SUBJECTS", BIOLOGICAL & PHARMACEUTICAL BULLETIN (OF JAPAN), PHARMACEUTICAL SOCIETY OF JAPAN, JP, vol. 24, no. 10, October 2001 (2001-10-01), pages 1176 - 1180, XP002951851, ISSN: 0918-6158
MEISEL P ET AL: "Prediction of metabolic activity from genotype: The gene-dose effect of N-acetyltransferase", THERAPEUTIC DRUG MONITORING, NEW YORK, NY, US, vol. 23, no. 1, February 2001 (2001-02-01), pages 9 - 14, XP009019868, ISSN: 0163-4356
HIRATSUKA M ET AL: "HIGH THROUGHPUT DETECTION OF DRUG-METABOLIZING ENZYME POLYMORPHISMS BY ALLELE-SPECIFIC FLUOROGENIC 5' NUCLEASE CHAIN REACTION ASSAY", BIOLOGICAL & PHARMACEUTICAL BULLETIN (OF JAPAN), PHARMACEUTICAL SOCIETY OF JAPAN, JP, vol. 23, no. 10, October 2000 (2000-10-01), pages 1131 - 1135, XP008026642, ISSN: 0918-6158
HUANG J X ET AL: "High-throughput genomic and proteomic analysis using microarray technology", CLINICAL CHEMISTRY, AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY. WINSTON, US, vol. 47, no. 10, October 2001 (2001-10-01), pages 1912 - 1916, XP002284875, ISSN: 0009-9147
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