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  1. Article ; Online: Exploring structure/property relationships to health and environmental hazards of polymeric polyisocyanate prepolymer substances-2. Dermal sensitization potential in the mouse local lymph node assay.

    West, Robert J / Burleson, Stefanie / Gulledge, Travis / Miller, Jason W / Chappelle, Anne H / Krieger, Shannon / Graham, Cynthia / Snyder, Stephanie / Simon, Glenn / Plehiers, Patrick M

    Toxicology and industrial health

    2022  Volume 38, Issue 9, Page(s) 556–577

    Abstract: The sensitization potencies of twenty custom-designed monomer-depleted polymeric polyisocyanate prepolymer substances and their associated toluene diisocyanate (TDI), methylene diphenyl diisocyanate (MDI), hexamethylene diisocyanate (HDI), and isophorone ...

    Abstract The sensitization potencies of twenty custom-designed monomer-depleted polymeric polyisocyanate prepolymer substances and their associated toluene diisocyanate (TDI), methylene diphenyl diisocyanate (MDI), hexamethylene diisocyanate (HDI), and isophorone diisocyanate (IPDI) monomer precursors were investigated by means of the mouse Local Lymph Node Assay (LLNA). These polymeric prepolymers were designed to represent the structural features and physical-chemical properties exhibited by a broad range of commercial polymeric polyisocyanate prepolymers that are produced from the reaction of aromatic and aliphatic diisocyanate monomers with aliphatic polyether and polyester polyols. The normalization of LLNA responses to the applied (15-45-135 mM) concentrations showed that the skin sensitization potency of polymeric polyisocyanate prepolymers is at least 300 times less than that of the diisocyanate monomers from which they are derived. The sensitization potency of the prepolymers was shown to be mainly governed by their hydrophobicity (as expressed by the calculated octanol-water partition coefficient, log K
    MeSH term(s) Animals ; Isocyanates/toxicity ; Local Lymph Node Assay ; Mice ; Polyurethanes/toxicity ; Respiratory System ; Toluene 2,4-Diisocyanate/toxicity
    Chemical Substances Isocyanates ; Polyurethanes ; Toluene 2,4-Diisocyanate (17X7AFZ1GH)
    Language English
    Publishing date 2022-05-27
    Publishing country England
    Document type Journal Article
    ZDB-ID 56831-4
    ISSN 1477-0393 ; 0748-2337
    ISSN (online) 1477-0393
    ISSN 0748-2337
    DOI 10.1177/07482337221089587
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 2268: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    ab Jg. 2022: Lesesaal (EG)

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  2. Article: In Vivo Assessment of Antibody-Dependent Enhancement of Influenza B Infection

    Rao, Gautham K / Prell, Rodney A / Laing, Steven T / Burleson, Stefanie C M / Nguyen, Allen / McBride, Jacqueline M / Zhang, Crystal / Sheinson, Daniel / Halpern, Wendy G

    Toxicological sciences. 2019 June 01, v. 169, no. 2

    2019  

    Abstract: A theoretical safety concern proposed in the influenza literature is that therapeutic antiviral antibodies could have the potential for antibody-dependent enhancement (ADE) of infection and disease. ADE may occur when virus-specific antibodies at ... ...

    Abstract A theoretical safety concern proposed in the influenza literature is that therapeutic antiviral antibodies could have the potential for antibody-dependent enhancement (ADE) of infection and disease. ADE may occur when virus-specific antibodies at subtherapeutic, nonneutralizing concentrations facilitate virus uptake and, in some cases, enhance replication, which can lead to an exacerbation of virus-mediated disease. Alternatively, ADE may occur due to antibody-dependent complement activation exacerbating virus-mediated disease in the absence of increased replication. As a result of this theoretical safety concern, safety assessment of anti-influenza antibodies may include an in vivo evaluation of ADE of infection and/or disease. These studies were conducted to investigate the potential of MHAB5553A, a broadly specific, neutralizing therapeutic anti-influenza B antibody, to elicit ADE of infection and disease in mouse models of influenza B infection. In parallel studies, female DBA/2J mice were infected with either influenza B/Victoria/504/2000 or influenza B/Brisbane/60/2008 representing distinct lineages. Assessment of ADE was based on an integration of results from multiple endpoints, including infectious lung viral titers and genomes, body weight, mortality, lung weight, and histopathology. In these studies, the high dose of 15 mg/kg MHAB5553A resulted in substantial attenuation of influenza pneumonia, with more modest effects at 1.5 mg/kg; whereas MHAB5553A treatment at 0.15 or 0.015 mg/kg was generally comparable to vehicle-treated controls. Our results demonstrate that MHAB5553A across a broad range of doses did not enhance primary influenza B infection or disease in this model, and represent a nonclinical de-risking of the ADE potential with this antibody.
    Keywords Influenza B virus ; antibodies ; body weight ; complement ; females ; genome ; histopathology ; human influenza ; in vivo studies ; lungs ; mortality ; neutralization ; pneumonia ; safety assessment ; therapeutics ; viral load ; viruses
    Language English
    Dates of publication 2019-0601
    Size p. 409-421.
    Publishing place Oxford University Press
    Document type Article
    ZDB-ID 1420885-4
    ISSN 1096-0929 ; 1096-6080
    ISSN (online) 1096-0929
    ISSN 1096-6080
    DOI 10.1093/toxsci/kfz053
    Database NAL-Catalogue (AGRICOLA)

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    Zs.A 1709: Show issues Location:
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  3. Article ; Online: Host Resistance Assays.

    Burleson, Stefanie C M / Freebern, Wendy Jo / Burleson, Florence G / Burleson, Gary R / Johnson, Victor J / Luebke, Robert W

    Methods in molecular biology (Clifton, N.J.)

    2018  Volume 1803, Page(s) 117–145

    Abstract: The goal of immunotoxicity testing is to obtain data useful for immunotoxicity safety assessment. Guidance in the performance of immunotoxicity safety evaluations is provided in documents from the US EPA for chemicals and the ICH S8 document for ... ...

    Abstract The goal of immunotoxicity testing is to obtain data useful for immunotoxicity safety assessment. Guidance in the performance of immunotoxicity safety evaluations is provided in documents from the US EPA for chemicals and the ICH S8 document for pharmaceuticals. The ICH S8 document outlines a tiered approach that includes (1) standard toxicity studies with associated hematology, immune system organ weights, and histopathology data; (2) functional assays, such as cytotoxic T lymphocyte (CTL) assays, natural killer (NK) cell assays, respiratory burst, phagocytosis, and T-cell-dependent antibody response (TDAR) assays; and (3) host resistance assays. Host resistance assays are considered the gold standard in immunotoxicity testing and provide a critical overview of the extent to which innate, adaptive, and homeostatic regulatory immune functions are integrated to protect the host. Both comprehensive and targeted host resistance assays are available, each with distinct advantages. This chapter serves to provide a general overview of the various assays that may be used, as well as a summary of procedures.
    MeSH term(s) Animals ; Bacteria/immunology ; Biological Assay/methods ; Disease Models, Animal ; Disease Resistance/immunology ; Humans ; Parasites/immunology ; Toxicity Tests/methods ; Viruses/immunology
    Language English
    Publishing date 2018-06-07
    Publishing country United States
    Document type Journal Article ; Review
    ISSN 1940-6029
    ISSN (online) 1940-6029
    DOI 10.1007/978-1-4939-8549-4_9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: In Vivo Assessment of Antibody-Dependent Enhancement of Influenza B Infection.

    Rao, Gautham K / Prell, Rodney A / Laing, Steven T / Burleson, Stefanie C M / Nguyen, Allen / McBride, Jacqueline M / Zhang, Crystal / Sheinson, Daniel / Halpern, Wendy G

    Toxicological sciences : an official journal of the Society of Toxicology

    2019  Volume 169, Issue 2, Page(s) 409–421

    Abstract: A theoretical safety concern proposed in the influenza literature is that therapeutic antiviral antibodies could have the potential for antibody-dependent enhancement (ADE) of infection and disease. ADE may occur when virus-specific antibodies at ... ...

    Abstract A theoretical safety concern proposed in the influenza literature is that therapeutic antiviral antibodies could have the potential for antibody-dependent enhancement (ADE) of infection and disease. ADE may occur when virus-specific antibodies at subtherapeutic, nonneutralizing concentrations facilitate virus uptake and, in some cases, enhance replication, which can lead to an exacerbation of virus-mediated disease. Alternatively, ADE may occur due to antibody-dependent complement activation exacerbating virus-mediated disease in the absence of increased replication. As a result of this theoretical safety concern, safety assessment of anti-influenza antibodies may include an in vivo evaluation of ADE of infection and/or disease. These studies were conducted to investigate the potential of MHAB5553A, a broadly specific, neutralizing therapeutic anti-influenza B antibody, to elicit ADE of infection and disease in mouse models of influenza B infection. In parallel studies, female DBA/2J mice were infected with either influenza B/Victoria/504/2000 or influenza B/Brisbane/60/2008 representing distinct lineages. Assessment of ADE was based on an integration of results from multiple endpoints, including infectious lung viral titers and genomes, body weight, mortality, lung weight, and histopathology. In these studies, the high dose of 15 mg/kg MHAB5553A resulted in substantial attenuation of influenza pneumonia, with more modest effects at 1.5 mg/kg; whereas MHAB5553A treatment at 0.15 or 0.015 mg/kg was generally comparable to vehicle-treated controls. Our results demonstrate that MHAB5553A across a broad range of doses did not enhance primary influenza B infection or disease in this model, and represent a nonclinical de-risking of the ADE potential with this antibody.
    MeSH term(s) Animals ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibody-Dependent Enhancement ; Body Weight ; Dose-Response Relationship, Drug ; Female ; Genome, Viral ; Influenza B virus/immunology ; Lung/pathology ; Lung/virology ; Mice ; Mice, Inbred DBA ; Orthomyxoviridae Infections/drug therapy ; Orthomyxoviridae Infections/pathology ; Orthomyxoviridae Infections/virology
    Chemical Substances Antibodies, Monoclonal, Humanized ; lesofavumab (J8O0SI025W)
    Language English
    Publishing date 2019-02-22
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1420885-4
    ISSN 1096-0929 ; 1096-6080
    ISSN (online) 1096-0929
    ISSN 1096-6080
    DOI 10.1093/toxsci/kfz053
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1709: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  5. Article ; Online: Nonclinical Profile of BLZ-100, a Tumor-Targeting Fluorescent Imaging Agent.

    Parrish-Novak, Julia / Byrnes-Blake, Kelly / Lalayeva, Narine / Burleson, Stefanie / Fidel, Janean / Gilmore, Rhonda / Gayheart-Walsten, Pamela / Bricker, Gregory A / Crumb, William J / Tarlo, K S / Hansen, Stacey / Wiss, Valorie / Malta, Errol / Dernell, William S / Olson, James M / Miller, Dennis M

    International journal of toxicology

    2017  Volume 36, Issue 2, Page(s) 104–112

    Abstract: BLZ-100 is a single intravenous use, fluorescent imaging agent that labels tumor tissue to enable more complete and precise surgical resection. It is composed of a chlorotoxin peptide covalently bound to the near-infrared fluorophore indocyanine green. ... ...

    Abstract BLZ-100 is a single intravenous use, fluorescent imaging agent that labels tumor tissue to enable more complete and precise surgical resection. It is composed of a chlorotoxin peptide covalently bound to the near-infrared fluorophore indocyanine green. BLZ-100 is in clinical development for intraoperative visualization of human tumors. The nonclinical safety and pharmacokinetic (PK) profile of BLZ-100 was evaluated in mice, rats, canines, and nonhuman primates (NHP). Single bolus intravenous administration of BLZ-100 was well tolerated, and no adverse changes were observed in cardiovascular safety pharmacology, PK, and toxicology studies in rats and NHP. The single-dose no-observed-adverse-effect-levels (NOAELs) were 7 mg (28 mg/kg) in rats and 60 mg (20 mg/kg) in NHP, corresponding to peak concentration values of 89 400 and 436 000 ng/mL and area-under-the-curve exposure values of 130 000 and 1 240 000 h·ng/mL, respectively. Based on a human imaging dose of 3 mg, dose safety margins are >100 for rat and monkey. BLZ-100 produced hypersensitivity reactions in canine imaging studies (lethargy, pruritus, swollen muzzle, etc). The severity of the reactions was not dose related. In a follow-up study in dogs, plasma histamine concentrations were increased 5 to 60 minutes after BLZ-100 injection; this coincided with signs of hypersensitivity, supporting the conclusion that the reactions were histamine based. Hypersensitivity reactions were not observed in other species or in BLZ-100 human clinical studies conducted to date. The combined imaging, safety pharmacology, PK, and toxicology studies contributed to an extensive initial nonclinical profile for BLZ-100, supporting first-in-human clinical trials.
    MeSH term(s) Animals ; Complement System Proteins/analysis ; Dogs ; Drug Hypersensitivity/blood ; Female ; Fluorescent Dyes/pharmacokinetics ; Fluorescent Dyes/toxicity ; HEK293 Cells ; Histamine/blood ; Humans ; Indocyanine Green/analogs & derivatives ; Indocyanine Green/pharmacokinetics ; Indocyanine Green/toxicity ; Macaca fascicularis ; Male ; Mice ; Neoplasms/diagnostic imaging ; Neoplasms/metabolism ; Rats, Sprague-Dawley ; Scorpion Venoms/blood ; Scorpion Venoms/pharmacokinetics ; Scorpion Venoms/toxicity
    Chemical Substances Fluorescent Dyes ; Scorpion Venoms ; Histamine (820484N8I3) ; tozuleristide (835UH424TU) ; Complement System Proteins (9007-36-7) ; Indocyanine Green (IX6J1063HV)
    Language English
    Publishing date 2017-03-17
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1379845-5
    ISSN 1092-874X ; 1091-5818
    ISSN (online) 1092-874X
    ISSN 1091-5818
    DOI 10.1177/1091581817697685
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1870: Show issues Location:
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