WO2017062568A1 - Biomarkers for diagnosing post traumatic stress disorder - Google Patents

Biomarkers for diagnosing post traumatic stress disorder Download PDF

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Publication number
WO2017062568A1
WO2017062568A1 PCT/US2016/055675 US2016055675W WO2017062568A1 WO 2017062568 A1 WO2017062568 A1 WO 2017062568A1 US 2016055675 W US2016055675 W US 2016055675W WO 2017062568 A1 WO2017062568 A1 WO 2017062568A1
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WO
WIPO (PCT)
Prior art keywords
subject
mcp
ptsd
mmr
levels
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English (en)
French (fr)
Inventor
Harvey B. Pollard
Clifton L. DALGARD
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Henry M Jackson Foundation for Advancedment of Military Medicine Inc
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Henry M Jackson Foundation for Advancedment of Military Medicine Inc
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Priority to US15/759,507 priority Critical patent/US11085934B2/en
Priority to AU2016334027A priority patent/AU2016334027A1/en
Priority to CA2998533A priority patent/CA2998533A1/en
Priority to JP2018517730A priority patent/JP2018536152A/ja
Priority to EP16854290.0A priority patent/EP3359969A4/en
Publication of WO2017062568A1 publication Critical patent/WO2017062568A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G01N33/6896—Neurological disorders, e.g. Alzheimer's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/15—Oximes (>C=N—O—); Hydrazines (>N—N<); Hydrazones (>N—N=) ; Imines (C—N=C)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4406—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 3, e.g. zimeldine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4525—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/521—Chemokines
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/30—Psychoses; Psychiatry

Definitions

  • the term TARC means a protein with an amino acid sequence at least about 75%, 80%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% identical to the amino acid sequence of SEQ I D NO:3.
  • the term TARC means a protein with an amino acid sequence at least about 75%, 80%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% identical to the amino acid sequence of SEQ ID NO:4.
  • the term M I P- ⁇ means a protein with an amino acid sequence at least about 75%, 80%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% identical to the amino acid sequence of SEQ I D NO:6 (mature CCL4).
  • the term M I P- ⁇ means a protein with an amino acid sequence at least about 75%, 80%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% identical to the amino acid sequence of SEQ ID NO:7 ( ⁇ ⁇ -1 ⁇ ).
  • identity is a measure of the identity of nucleotide sequences or amino acid sequences compared to a reference nucleotide or amino acid sequence. In general, the sequences are aligned so that the highest order match is obtained. "Identity” per se has an art-recognized meaning and can be calculated using published techniques. ⁇ See, e.g., Computational Molecular Biology, Lesk, A. M., ed., Oxford University Press, New York (1988); Biocomputing: Informatics And Genome Projects, Smith, D. W., ed., Academic Press, New York (1993); Computer Analysis of Sequence Data, Part I, Griffin, A. M., and Griffin, H.
  • the terms “correspond(s) to” and “corresponding to,” as they relate to sequence alignment, are intended to mean enumerated positions within the reference protein, e.g., wild-type MCP-1, and those positions in a mutant or related MCP-1 that align with the positions on the reference protein.
  • the amino acid sequence of a subject peptide is aligned with the amino acid sequence of a reference MCP-1, e.g., SEQ I D NO:2
  • the amino acids in the subject sequence that "correspond to" certain enumerated positions of the reference sequence are those that align with these positions of the reference sequence, e.g., SEQ I D NO:2, but are not necessarily in these exact numerical positions of the reference sequence.
  • embodiments of the present invention comprise detecting or determining levels (or ratios thereof) of biomarkers, with the biomarkers corresponding to MCP-1, MCP-4, TARC and/or ⁇ ⁇ ⁇ -1 ⁇ .
  • the attributable risk can also be used to express an increased risk.
  • the AR describes the proportion of individuals in a population exhibiting PTSD due to a specific member of the M MR or TARC levels and/or M IP- ⁇ levels .
  • AR may also be important in quantifying the role of individual components (specific member, e.g., MCP-4 or MCP-1) in condition etiology and in terms of the public health impact of the individual marker.
  • the public health relevance of the AR measurement lies in estimating the proportion of cases of PTSD in the population that could be prevented if the MM R, TARC levels and/or M I P- ⁇ levels or individual component were considered normal.
  • levels of individual components of the M M R, TARC levels and/or ⁇ ⁇ -1 ⁇ levels from test samples are well known to the skilled technician, and the invention is not limited by the means by which the components are assessed.
  • levels of the individual components of the M MR, TARC levels and/or MI P- ⁇ levels are assessed using mass spectrometry in conjunction with ultra-performance liquid chromatography (U PLC), high-performance liquid chromatography (H PLC), and UPLC to name a few.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2016/055675 2015-10-08 2016-10-06 Biomarkers for diagnosing post traumatic stress disorder Ceased WO2017062568A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US15/759,507 US11085934B2 (en) 2015-10-08 2016-10-06 Biomarkers for diagnosing post traumatic stress disorder
AU2016334027A AU2016334027A1 (en) 2015-10-08 2016-10-06 Biomarkers for diagnosing post traumatic stress disorder
CA2998533A CA2998533A1 (en) 2015-10-08 2016-10-06 Biomarkers for diagnosing post traumatic stress disorder
JP2018517730A JP2018536152A (ja) 2015-10-08 2016-10-06 心的外傷後ストレス障害を診断するためのバイオマーカー
EP16854290.0A EP3359969A4 (en) 2015-10-08 2016-10-06 METHOD FOR DIAGNOSIS OF POST-AUTOMATIC LOAD FAULTS

Applications Claiming Priority (2)

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US201562239004P 2015-10-08 2015-10-08
US62/239,004 2015-10-08

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WO2017062568A1 true WO2017062568A1 (en) 2017-04-13

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US (1) US11085934B2 (enExample)
EP (1) EP3359969A4 (enExample)
JP (1) JP2018536152A (enExample)
AU (1) AU2016334027A1 (enExample)
CA (1) CA2998533A1 (enExample)
WO (1) WO2017062568A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11529054B2 (en) * 2018-07-25 2022-12-20 The Charles Stark Draper Laboratory, Inc. Method and system for post-traumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) diagnosis using magnetic resonance spectroscopy
WO2025154785A1 (ja) * 2024-01-18 2025-07-24 国立研究開発法人産業技術総合研究所 心的外傷後ストレス障害（ｐｔｓｄ）または急性ストレス障害（ａｓｄ）の客観的評価方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140220019A1 (en) * 2010-08-03 2014-08-07 Abbvie, Inc. Dual variable domain immunoglobulins and uses thereof
US20150259740A1 (en) * 2011-09-14 2015-09-17 Harvey Pollard Processes and kits to detect and monitor for diagnostic biomarkers for post traumatic stress disorder (ptsd) and to differentiate between suicidal and non-suicidal form of the disorder
WO2016057775A1 (en) * 2014-10-08 2016-04-14 The Henry M. Jackson Foundation For The Advancement Of Military Medicine, Inc. Biomarkers for diagnosing post traumatic stress disorder

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY151424A (en) * 2006-02-17 2014-05-30 Sekiyama Atsuo Biological load indicator and method of measuring biological load

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140220019A1 (en) * 2010-08-03 2014-08-07 Abbvie, Inc. Dual variable domain immunoglobulins and uses thereof
US20150259740A1 (en) * 2011-09-14 2015-09-17 Harvey Pollard Processes and kits to detect and monitor for diagnostic biomarkers for post traumatic stress disorder (ptsd) and to differentiate between suicidal and non-suicidal form of the disorder
WO2016057775A1 (en) * 2014-10-08 2016-04-14 The Henry M. Jackson Foundation For The Advancement Of Military Medicine, Inc. Biomarkers for diagnosing post traumatic stress disorder

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
EBIOSCIENCE.COM: "AntiHuman CCL4 (MIP1beta);", WEBPAGE, 6 April 2015 (2015-04-06), pages 1, XP009509601, Retrieved from the Internet <URL:http://www.ebioscience.com/human-ccl4-antibody-apc-fl34z31.htm> *
INVITROGEN.COM: "TARC/CCL17 ABfinity? Recombinant Rabbit Monoclonal Antibody - Purified.", WEBPAGE, 10 January 2011 (2011-01-10), pages 1, XP055376182, Retrieved from the Internet <URL:https://tools.thermofisher.com/content/sfs/manuals/700655_rb_x_TARC_mab.pdf> *
POLLARD, H.B. ET AL.: "Uncovering Novel Biomarkers for Early Diagnosis of PostTraumatic Stress Disorder (PTSD);", WEBPAGE, 26 February 2014 (2014-02-26), XP055522227, Retrieved from the Internet <URL:http://cdmrp.army.mil/phtbi/research_highlights/15pollard_highlight> *
See also references of EP3359969A4 *
THERMOFISHER.COM: "SAFETY DATA SHEET.", WEBPAGE, 30 April 2014 (2014-04-30), pages 1, XP055376179, Retrieved from the Internet <URL:https://tools.thermofisher.com/content/sfs/msds/2015/RF8937_MTR-NARF_EN.pdf> *

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AU2016334027A1 (en) 2018-04-05
EP3359969A4 (en) 2019-05-22
JP2018536152A (ja) 2018-12-06
US20190113526A1 (en) 2019-04-18
US11085934B2 (en) 2021-08-10
CA2998533A1 (en) 2017-04-13
EP3359969A1 (en) 2018-08-15

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