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Volumn 31, Issue 4, 2012, Pages 303-316

Preclinical safety, pharmacokinetics, and pharmacodynamics of recombinant human interleukin-21 in cynomolgus macaques (macaca fascicularis)

Author keywords

cynomolgus monkey; IL 21; pathology; pharmacokinetics; preclinical safety; toxicology

Indexed keywords

ALANINE DEHYDROGENASE; ALBUMIN; BILIRUBIN; FIBRINOGEN; GAMMA INTERFERON; INTERLEUKIN 1BETA; INTERLEUKIN 21; INTERLEUKIN 6; LACTATE DEHYDROGENASE; RECOMBINANT INTERLEUKIN 21; STAT3 PROTEIN; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

EID: 84865040840     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1177/1091581812449661     Document Type: Article
Times cited : (13)

References (35)
  • 1
    • 0034597789 scopus 로고    scopus 로고
    • Interleukin 21 and its receptor are involved in NK cell expansion and regulation of lymphocyte function
    • Parrish-Novak J, Dillon SR, Nelson A, et al. Interleukin 21 and its receptor are involved in NK cell expansion and regulation of lymphocyte function. Nature. 2000 ; 408 (6808). 57-63
    • (2000) Nature , vol.408 , Issue.6808 , pp. 57-63
    • Parrish-Novak, J.1    Dillon, S.R.2    Nelson, A.3
  • 2
    • 0036852893 scopus 로고    scopus 로고
    • Interleukin-21 and the IL-21 receptor: Novel effectors of NK and T cell responses
    • Parrish-Novak J, Foster DC, Holly RD, Clegg CH. Interleukin-21 and the IL-21 receptor: novel effectors of NK and T cell responses. J Leukoc Biol. 2002 ; 72 (5). 856-863 (Pubitemid 35365159)
    • (2002) Journal of Leukocyte Biology , vol.72 , Issue.5 , pp. 856-863
    • Parrish-Novak, J.1    Foster, D.C.2    Holly, R.D.3    Clegg, C.H.4
  • 4
    • 2542595794 scopus 로고    scopus 로고
    • + T cell responses to achieve durable tumor immunity: Comparative evaluation of IL-2, IL-15, and IL-21
    • Moroz A, Eppolito C, Li Q, Tao J, Clegg CH, Shrikant PA. IL-21 enhances and sustains CD8+ T cell responses to achieve durable tumor immunity: comparative evaluation of IL-2, IL-15, and IL-21. J Immunol.. 2004 ; 173 (2). 900-909 (Pubitemid 38924263)
    • (2004) Journal of Immunology , vol.173 , Issue.2 , pp. 900-909
    • Moroz, A.1    Eppolito, C.2    Li, Q.3    Tao, J.4    Clegg, C.H.5    Shrikant, P.A.6
  • 5
    • 0842278642 scopus 로고    scopus 로고
    • IL-21 Induces the Functional Maturation of Murine NK Cells
    • Brady J, Hayakawa Y, Smyth MJ, Nutt SL. IL-21 induces the functional maturation of murine NK cells. J Immunol. 2004 ; 172 (4). 2048-2058 (Pubitemid 38182350)
    • (2004) Journal of Immunology , vol.172 , Issue.4 , pp. 2048-2058
    • Brady, J.1    Hayakawa, Y.2    Smyth, M.J.3    Nutt, S.L.4
  • 8
    • 84872489871 scopus 로고    scopus 로고
    • S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
    • International Conference on Harmonisation. Guidance for Industry. S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; 1997. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM074957.pdfaccessed 4 May 2012.
    • (1997) International Conference on Harmonisation. Guidance for Industry
  • 11
    • 0037093609 scopus 로고    scopus 로고
    • Nonclinical evaluation of therapeutic cytokines: Immunotoxicologic issues
    • DOI 10.1016/S0300-483X(02)00054-9, PII S0300483X02000549
    • Thomas P. Nonclinical evaluation of therapeutic cytokines: immunotoxicologic issues. Toxicology. 2002 ; 174 (1). 27-35 (Pubitemid 34327824)
    • (2002) Toxicology , vol.174 , Issue.1 , pp. 27-35
    • Thomas, P.T.1
  • 13
    • 0141563862 scopus 로고    scopus 로고
    • Preclinical safety of recombinant human interleukin-18
    • DOI 10.1080/01926230309794
    • Herzyk DJ, Bugelski PJ, Hart TK, Wier PJ. Preclinical safety of recombinant human interleukin-18. Toxicol Pathol. 2003 ; 31 (5). 554-561 (Pubitemid 37151428)
    • (2003) Toxicologic Pathology , vol.31 , Issue.5 , pp. 554-561
    • Herzyk, D.J.1    Bugelski, P.J.2    Hart, T.K.3    Wier, P.J.4
  • 14
    • 0029586795 scopus 로고    scopus 로고
    • Fatal vascular leak syndrome with extensive hemorrhage, peripheral neuropathy and reactive erythrophagocytosis: An unusual complication of recombinant IL-3 therapy
    • Hurwitz N, Probst A, Zufferey G, et al. Fatal vascular leak syndrome with extensive hemorrhage, peripheral neuropathy and reactive erythrophagocytosis: an unusual complication of recombinant IL-3 therapy. Leuk Lymphoma. 1996 ; 20 (3-4). 337-340 (Pubitemid 126714890)
    • (1996) Leukemia and Lymphoma , vol.20 , Issue.3-4 , pp. 337-340
    • Hurwitz, N.1    Probst, A.2    Zufferey, G.3    Tichell, A.4    Pless, M.5    Kappos, L.6    Speck, B.7    Gratwohl, A.8
  • 16
    • 0026475205 scopus 로고
    • Clinical toxicity of interleukin-2
    • Vial T, Descotes J. Clinical toxicity of interleukin-2. Drug Saf. 1992 ; 7 (6). 417-33
    • (1992) Drug Saf , vol.7 , Issue.6 , pp. 417-433
    • Vial, T.1    Descotes, J.2
  • 18
    • 0035135745 scopus 로고    scopus 로고
    • Agranulocytosis and hemolytic anemia in patients with renal cell cancer treated with interleukin-12
    • DOI 10.1097/00002371-200101000-00011
    • Gollob JA, Veenstra KG, Mier JW, Atkins MB. Agranulocytosis and hemolytic anemia in patients with renal cell cancer treated with interleukin-12. J Immunother. 2001 ; 24 (1). 91-98 (Pubitemid 32101971)
    • (2001) Journal of Immunotherapy , vol.24 , Issue.1 , pp. 91-98
    • Gollob, J.A.1    Veenstra, K.G.2    Mier, J.W.3    Atkins, M.B.4
  • 19
    • 0029112458 scopus 로고
    • Interleukin-6-associated anemia: Determination of the underlying mechanism
    • Atkins MB, Kappler K, Mier JW, Isaacs RE, Berkman EM. Interleukin-6-associated anemia: determination of the underlying mechanism. Blood. 1995 ; 86 (4). 1288-1291
    • (1995) Blood , vol.86 , Issue.4 , pp. 1288-1291
    • Atkins, M.B.1    Kappler, K.2    Mier, J.W.3    Isaacs, R.E.4    Berkman, E.M.5
  • 21
    • 0034606359 scopus 로고    scopus 로고
    • Follicular B helper T cells express CXC chemokine receptor 5, localize to B cell follicles, and support immunoglobulin production
    • Breitfeld D, Ohl L, Kremmer E, et al. Follicular B helper T cells express CXC chemokine receptor 5, localize to B cell follicles, and support immunoglobulin production. J Exp Med. 2000 ; 192 (11). 1545-1551
    • (2000) J Exp Med , vol.192 , Issue.11 , pp. 1545-1551
    • Breitfeld, D.1    Ohl, L.2    Kremmer, E.3
  • 22
  • 23
    • 33750475605 scopus 로고    scopus 로고
    • Normal structure, function and histology of the thymus
    • DOI 10.1080/01926230600865549, PII J53G89G90G5N6764
    • Pearse G. Normal structure, function, and histology of the thymus. Toxicol Pathol. 2006 ; 34 (5). 504-514 (Pubitemid 44652215)
    • (2006) Toxicologic Pathology , vol.34 , Issue.5 , pp. 504-514
    • Pearse, G.1
  • 24
    • 0029550774 scopus 로고
    • Mechanism of insulin and IGF-I receptor activation and signal transduction specificity. Receptor dimer cross-linking, bell-shaped curves, and sustained versus transient signaling
    • DOI 10.1111/j.1749-6632.1995.tb26688.x
    • De Meyts P, Urso B, Christoffersen CT, et al. Mechanism of insulin and IGF-1 receptor activation and signal transduction specificity. Receptor dimer cross-linking, bell-shaped curves, and sustained versus transient signaling. Ann N Y Acad Sci. 1995 ; 766: 388-401 (Pubitemid 26169119)
    • (1995) Annals of the New York Academy of Sciences , vol.766 , pp. 388-401
    • De Meyts, P.1    Urso, B.2    Christoffersen, C.T.3    Shymko, R.M.4
  • 26
    • 26844443905 scopus 로고    scopus 로고
    • Immunogenicity of tissue plasminogen activators in rhesus monkeys: Antibody formation and effects on blood level and enzymatic activity
    • Zwickl CM, Hughes BL, Piroozi KS, Smith HW, Wierda D. Immunogenicity of tissue plasminogen activators in rhesus monkeys: antibody formation and effects on blood level and enzymatic activity. Fundam Appl Toxicol. 1996 ; 30 (2). 243-254
    • (1996) Fundam Appl Toxicol , vol.30 , Issue.2 , pp. 243-254
    • Zwickl, C.M.1    Hughes, B.L.2    Piroozi, K.S.3    Smith, H.W.4    Wierda, D.5
  • 27
    • 0036890997 scopus 로고    scopus 로고
    • Immune responses to therapeutic proteins in humans - Clinical significance, assessment and prediction
    • DOI 10.2174/1389201023378175
    • Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans - clinical significance, assessment and prediction. Curr Pharm Biotechnol. 2002 ; 3 (4). 349-360 (Pubitemid 35364009)
    • (2002) Current Pharmaceutical Biotechnology , vol.3 , Issue.4 , pp. 349-360
    • Koren, E.1    Zuckerman, L.A.2    Mire-Sluis, A.R.3
  • 28
    • 0027345589 scopus 로고
    • Comparative toxicity and pathology associated with administration of recombinant IL-2 to animals
    • Anderson TD, Hayes TJ, Powers GD, Gately MK, Tudor R, Rushton A. Comparative toxicity and pathology associated with administration of recombinant IL-2 to animals. Int Rev Exp Pathol. 1993 ; 34 (pt A). 57-77
    • (1993) Int Rev Exp Pathol , vol.34 , Issue.PART A , pp. 57-77
    • Anderson, T.D.1    Hayes, T.J.2    Powers, G.D.3    Gately, M.K.4    Tudor, R.5    Rushton, A.6
  • 29
    • 0027344034 scopus 로고
    • Pathogenesis of toxicity with human-derived interleukin-2 in experimental animals
    • Harada Y, Yahara I. Pathogenesis of toxicity with human-derived interleukin-2 in experimental animals. Int Rev Exp Pathol. 1993 ; 34 (pt A). 37-55
    • (1993) Int Rev Exp Pathol , vol.34 , Issue.PART A , pp. 37-55
    • Harada, Y.1    Yahara, I.2
  • 30
    • 0030862195 scopus 로고    scopus 로고
    • Vascular leak syndrome: A side effect of immunotherapy
    • DOI 10.1016/S0162-3109(97)00041-6, PII S0162310997000416
    • Baluna R, Vitetta ES. Vascular leak syndrome: a side effect of immunotherapy. Immunopharmacology. 1997 ; 37 (2-3). 117-132 (Pubitemid 27471029)
    • (1997) Immunopharmacology , vol.37 , Issue.2-3 , pp. 117-132
    • Baluna, R.1    Vitetta, E.S.2
  • 31
    • 42949139835 scopus 로고    scopus 로고
    • Phase i study of recombinant interleukin-21 in patients with metastatic melanoma and renal cell carcinoma
    • Thompson JA, Curti BD, Redman BG, et al. Phase I study of recombinant interleukin-21 in patients with metastatic melanoma and renal cell carcinoma. J Clin Oncol. 2008 ; 26 (12). 2034-2039
    • (2008) J Clin Oncol , vol.26 , Issue.12 , pp. 2034-2039
    • Thompson, J.A.1    Curti, B.D.2    Redman, B.G.3
  • 32
    • 63449095686 scopus 로고    scopus 로고
    • Clinical and biological efficacy of recombinant human interleukin-21 in patients with stage IV malignant melanoma without prior treatment: A Phase IIa trial
    • Davis ID, Brady B, Kefford RF, et al. Clinical and biological efficacy of recombinant human interleukin-21 in patients with stage IV malignant melanoma without prior treatment: a Phase IIa trial. Clin Cancer Res. 2009 ; 15 (6). 2123-2129
    • (2009) Clin Cancer Res , vol.15 , Issue.6 , pp. 2123-2129
    • Davis, I.D.1    Brady, B.2    Kefford, R.F.3
  • 34
    • 76049086133 scopus 로고    scopus 로고
    • Acute phase response in animals: A review
    • Cray C, Zaias J, Altman NH. Acute phase response in animals: a review. Comp Med. 2009 ; 59 (6). 517-526
    • (2009) Comp Med , vol.59 , Issue.6 , pp. 517-526
    • Cray, C.1    Zaias, J.2    Altman, N.H.3
  • 35
    • 63949086742 scopus 로고    scopus 로고
    • Immune activation in advanced cancer patients treated with recombinant IL-21: Multianalyte profiling of serum proteins
    • Dodds MG, Fredericksen KS, Skak K, et al. Immune activation in advanced cancer patients treated with recombinant IL-21: multianalyte profiling of serum proteins. Cancer Immunol Immunother. 2009 ; 58 (6). 843-854
    • (2009) Cancer Immunol Immunother , vol.58 , Issue.6 , pp. 843-854
    • Dodds, M.G.1    Fredericksen, K.S.2    Skak, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.