Overview of the marmoset as a model in nonclinical development of pharmaceutical products

Regulatory Toxicology and Pharmacology - Tập 59 Số 1 - Trang 19-27 - 2011
Antonia Orsi1, Daryl Rees1, Isabella Andreini2, Silvana Venturella2, Serena Cinelli2, Germano Oberto2
1Salupont Consulting Ltd., Kent Science Park, 940 Cornforth Drive, Sittingbourne, Kent, ME9 8PX, UK.
2Research Toxicology Centre S.p.A, Via Tito Speri, 12/14 00040 Pomezia, RM, Italy

Tóm tắt

Từ khóa


Tài liệu tham khảo

Abbott, 2003, Aspects of common marmoset basic biology and life history important for biomedical research, Comp. Med., 53, 12

Badihi, 2007, The effects of increased space, complexity, and choice, together with their loss, on the behavior of a family group of Callithrix jacchus: a case study, Lab. Prim. Newslett., 46, 1

Barrett, 2007, The testosterone test: phthalate inhibits leydig cell aggregation, Environ. Health Perspect., 115, A153, 10.1289/ehp.115-a153a

Barton, 1984, Binding of human lymphocyte-specific monoclonal antibodies to common marmoset lymphoid cells, Cell. Immunol., 84, 446, 10.1016/0008-8749(84)90119-9

Baskerville, 1999, Old World monkeys, 611

Boon, 2001, Prevention of experimental autoimmune encephalomyelitis in the common marmoset (Callithrix jacchus) using a chimeric antagonist monoclonal antibody against human CD40 is associated with altered B cell responses, J. Immunol., 167, 2942, 10.4049/jimmunol.167.5.2942

Boretius, 2006, Monitoring of EAE onset and progression in the common marmoset monkey by sequential high-resolution 3D MRI, NMR Biomed., 19, 41, 10.1002/nbm.999

Broadmeadow, 2005, The common marmoset (Callithrix jacchus) in preclinical research and development of new pharmaceutical products, J. Toxicol. Sci., 30, S123

Brysch, 1990, The topology of the thalamo-cortical projections in the marmoset monkey (Callithrix jacchus), Exp. Brain Res., 81, 1, 10.1007/BF00230095

Bullock, 1995, Induction of liver microsomal cytochrome P450 in cynomolgus monkeys, Drug Metab. Dispos., 23, 736

Butler, 1989, Metabolic oxidation of the carcinogens 4-aminobiphenyl and 4,4′-methylene-bis(2-chloroaniline) by human hepatic microsomes and by purified rat hepatic cytochrome P-450 monooxygenases, Cancer Res., 49, 25

Cilia, 2001, Clozapine enhances breakpoint in common marmosets responding on a progressive ratio schedule, Psychopharmacology (Berl.), 155, 135, 10.1007/s002130100682

Cline, 2007, Assessing the mammary gland of nonhuman primates: effects of endogenous hormones and exogenous hormonal agents and growth factors, Birth Defects Res. B Dev. Reprod. Toxicol., 80, 126, 10.1002/bdrb.20112

Commision of the European Communities, E., 2007. Fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union. p. 277.

Cyranoski, 2009, Marmoset model takes centre stage, Nature, 459, 492, 10.1038/459492a

Datson, 2007, Development of the first marmoset-specific DNA microarray (EUMAMA): a new genetic tool for large-scale expression profiling in a non-human primate, BMC Genomics, 8, 190, 10.1186/1471-2164-8-190

Datson, 2009, A molecular blueprint of gene expression in hippocampal subregions CA1, CA3, and DG is conserved in the brain of the common marmoset, Hippocampus, 19, 739, 10.1002/hipo.20555

Davy, 1984, Reference intervals for some clinical chemical parameters in the marmoset (Callithrix jacchus): effect of age and sex, Lab. Anim., 18, 135, 10.1258/002367784780891217

Dawson, 2002, Neuroprotective and neurorestorative strategies for Parkinson’s disease, Nat. Neurosci., 5, 1058, 10.1038/nn941

Diem, 2008, Autoimmune optic neuritis in the common marmoset monkey: comparison of visual evoked potentials with MRI and histopathology, Invest. Ophthalmol. Vis. Sci., 49, 3707, 10.1167/iovs.08-1896

Dunbar, 2006, Applications of Luminex xMAP technology for rapid, high-throughput multiplexed nucleic acid detection, Clin. Chim. Acta, 363, 71, 10.1016/j.cccn.2005.06.023

Dutton, 1980

Eason, 1988, Species variation in gastric toxicity following chronic administration of ciprofibrate to rat, mouse, and marmoset, Toxicol. Appl. Pharmacol., 95, 328, 10.1016/0041-008X(88)90169-X

Eden, 1991, Preclinical pharmacology of ropinirole (SK&F 101468-A) a novel dopamine D2 agonist, Pharmacol. Biochem. Behav., 38, 147, 10.1016/0091-3057(91)90603-Y

Edwards, 1994, Contribution of CYP1A1 and CYP1A2 to the activation of heterocyclic amines in monkeys and human, Carcinogenesis, 15, 829, 10.1093/carcin/15.5.829

Eslamboli, 2005, Marmoset monkey models of Parkinson’s disease: which model, when and why?, Brain Res. Bull., 68, 140, 10.1016/j.brainresbull.2005.08.005

Eslamboli, 2007, Long-term consequences of human alpha-synuclein overexpression in the primate ventral midbrain, Brain, 130, 799, 10.1093/brain/awl382

Gaudy, 1987, The effects of cremophor EL in the anaesthetized dog, Can. J. Anaesth., 34, 122, 10.1007/BF03015328

Genain, 1997, Creation of a model for multiple sclerosis in Callithrix jacchus marmosets, J. Mol. Med., 75, 187, 10.1007/s001090050103

Graham, 1994, Lack of peroxisome proliferation in marmoset liver following treatment with ciprofibrate for 3years, Fundam. Appl. Toxicol., 22, 58, 10.1006/faat.1994.1008

Guldin, 1993, Connections from the neocortex to the vestibular brain stem nuclei in the common marmoset, NeuroReport, 5, 113, 10.1097/00001756-199311180-00004

Heger, 1988, Embryotoxic effects of thalidomide derivatives on the non-human primate Callithrix jacchus; 3. Teratogenic potency of the EM 12 enantiomers, Arch. Toxicol., 62, 205, 10.1007/BF00570141

Heger, 1994, Embryotoxic effects of thalidomide derivatives in the non-human primate Callithrix jacchus. IV. Teratogenicity of micrograms/kg doses of the EM12 enantiomers, Teratog. Carcinog. Mutagen., 14, 115, 10.1002/tcm.1770140303

Hillier, 1997, Location and developmental regulation of androgen receptor in primate ovary, Hum. Reprod., 12, 107, 10.1093/humrep/12.1.107

Hoffmann-LaRoche, 2008. Product monograph: Inhibace® (cilazapril).

Hoffmann-LaRoche, 2009. Product monograph: Tamiflu® (oseltamivir phosphate capsule).

Hoffmann-LaRoche, 2009 Product monograph: Invirase® (Saquinavir mesylate).

Hohjoh, 2009, Molecular cloning and characterization of the common marmoset Huntington gene, Gene, 432, 60, 10.1016/j.gene.2008.11.012

Home–Office, 2000. Statistics of Scientific Procedures on Living Animals Great Britain.

Hornung, 1990, Distribution of two morphologically distinct subsets of serotoninergic axons in the cerebral cortex of the marmoset, J. Comp. Neurol., 297, 165, 10.1002/cne.902970202

http://ucscbrowser.genenetwork.org/goldenPath/newsarch.html#030610, 2010. (3 June 2010) – Updated Marmoset Genome Browser Available.

http://www.biomedcentral.com/content/supplementary/1471-2164-8-190-S2.xls, 2007. Overview of 3215 sequences submitted to GenBank and dbEST (Datson et al., 2007).

http://www.sfbr.org/SNPRC/detail.aspx?r=60, 2010. Immunology Core Laboratory.

Hu, 2007, A rapid, multiplexed new technology xMAP liquid chip for detection and identification of pathogens, Wei Sheng Yan Jiu, 36, 759

Husen, 2001, Mechanisms of estradiol inactivation in primate endometrium, Mol. Cell. Endocrinol., 171, 179, 10.1016/S0303-7207(00)00421-4

ICH-Topic-M3(R2), 2009. Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals.

ICH-Topic-S7A, 2000. Safety Pharmacology Studies for Human Pharmaceuticals.

ICH-Topic-S7B, 2005. The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.

Kametani, 2009, Development of monoclonal antibodies for analyzing immune and hematopoietic systems of common marmoset, Exp. Hematol., 37, 1318, 10.1016/j.exphem.2009.08.003

Kendall, 2000, The influence of excitotoxic basal ganglia lesions on motor performance in the common marmoset, Brain, 123, 1442, 10.1093/brain/123.7.1442

Kendall, 2000, Striatal tissue transplantation in non-human primates, Prog. Brain Res., 127, 381, 10.1016/S0079-6123(00)27018-0

Kendall, 1998, Functional integration of striatal allografts in a primate model of Huntington’s disease, Nat. Med., 4, 727, 10.1038/nm0698-727

Kireta, 2005, Cross-reactivity of anti-human chemokine receptor and anti-TNF family antibodies with common marmoset (Callithrix jacchus) leukocytes, Cell. Immunol., 236, 115, 10.1016/j.cellimm.2005.08.017

Kirik, 2003, Nigrostriatal alpha-synucleinopathy induced by viral vector-mediated overexpression of human alpha-synuclein: a new primate model of Parkinson’s disease, Proc. Natl. Acad. Sci. USA, 100, 2884, 10.1073/pnas.0536383100

Klug, 1994, Embryotoxic effects of thalidomide derivatives in the non-human primate Callithrix jacchus 5 Lack of teratogenic effects of phthalimidophthalmide, Arch. Toxicol., 68, 203, 10.1007/s002040050055

Koehler, 2006, Marmoset CYP3A21, a model for human CYP3A4: protein expression and functional characterization of the promoter, Xenobiotica, 36, 1210, 10.1080/00498250600962831

Kurata, 1997, Four-week repeated inhalation study of HCFC 225ca and HCFC 225cb in the common marmoset, Toxicol. Lett., 92, 209, 10.1016/S0378-4274(97)00059-3

Kuzel, 1990, Screening procedure for assessment of ototoxicity in the common marmoset, J. Pharmacol. Methods, 24, 9, 10.1016/0160-5402(90)90045-M

Luetjens, 2005, Primate spermatogenesis: new insights into comparative testicular organisation, spermatogenic efficiency and endocrine control, Biol. Rev. Camb. Philos. Soc., 80, 475, 10.1017/S1464793105006755

Luetjens, 2008, The fate of paternal mitochondria in marmoset pre-implantation embryos, J. Med. Primatol., 37, 128, 10.1111/j.1600-0684.2007.00252.x

Makowska, 1992, Species differences in ciprofibrate induction of hepatic cytochrome P450 4A1 and peroxisome proliferation, J. Biochem. Toxicol., 7, 183, 10.1002/jbt.2570070308

Mansfield, K., Tardif, S., Eichler, E.E., 2004. White Paper for Complete sequencing of the common marmoset (Callithrix jacchus) genome. http://www.genome.gov/Pages/Research/Sequencing/SeqProposals/MarmosetSeq.pdf.

Marshall, 2003, Functional and histological evidence for the protective effect of NXY-059 in a primate model of stroke when given 4h after occlusion, Stroke, 34, 2228, 10.1161/01.STR.0000087790.79851.A8

Marshall, 2003, Ovarian stimulation of marmoset monkeys (Callithrix jacchus) using recombinant human follicle stimulating hormone, J. Med. Primatol., 32, 57, 10.1034/j.1600-0684.2003.00003.x

Marshall, 1997, Nonsurgical embryo transfer in the common marmoset monkey, J. Med. Primatol., 26, 241, 10.1111/j.1600-0684.1997.tb00218.x

Marshall, 1998, Parthenogenetic activation of marmoset (Callithrix jacchus) oocytes and the development of marmoset parthenogenones in vitro and in vivo, Biol. Reprod., 59, 1491, 10.1095/biolreprod59.6.1491

Matsumoto, K., Ochiai, T., Sekita, K., Kawasaki, Y., Yasuhara, K., Nakaji, Y., Furuya, T., Kurokawa, Y., Tobe, M., 1987. Six-month toxicity study with mitomycin C in marmosets. Jpn. Soc. Toxicol., Tokyo.

McArthur, 2003, Phylogenetic analysis of the cytochrome P450 3 (CYP3) gene family, J. Mol. Evol., 57, 200, 10.1007/s00239-003-2466-x

Merkler, 2006, Myelin oligodendrocyte glycoprotein-induced experimental autoimmune encephalomyelitis in the common marmoset reflects the immunopathology of pattern II multiple sclerosis lesions, Mult. Scler., 12, 369, 10.1191/1352458506ms1290oa

Millar, 2000, Marmoset spermatogenesis: organizational similarities to the human, Int. J. Androl., 23, 266, 10.1046/j.1365-2605.2000.00236.x

Committee for the Update of the Guide for the Care and Use of Laboratory Animals; National Research Council, 2010. Guide for the Care and Use of Laboratory Animals: Eighth Edition. The National Academies Press.

Nelson, 2004, Comparison of cytochrome P450 (CYP) genes from the mouse and human genomes, including nomenclature recommendations for genes, pseudogenes and alternative-splice variants, Pharmacogenetics, 14, 1, 10.1097/00008571-200401000-00001

Neubert, 1996, Cross-reactivity of antihuman monoclonal antibodies with cell surface receptors in the common marmoset, Life Sci., 58, 317, 10.1016/0024-3205(95)02291-0

Neubert, 1996, Down-regulation of adhesion receptors on cells of primate embryos as a probable mechanism of the teratogenic action of thalidomide, Life Sci., 58, 295, 10.1016/0024-3205(95)02290-2

Neubert, 1993, Effects of small doses of dioxins on the immune system of marmosets and rats, Ann. N. Y. Acad. Sci., 685, 662, 10.1111/j.1749-6632.1993.tb35931.x

Niblack, 1977, T-and B-lymphocyte chimerism in the marmoset, Immunology, 32, 257

Oberto, 1990, Evaluation of the toxicity of indomethacin in a 4-week study, by oral route, in the marmoset (Callithrix jacchus), Fundam. Appl. Toxicol., 15, 800, 10.1016/0272-0590(90)90196-Q

OJ-L-197-(vol-50), 2007. Commission Recommendation of 18 June 2007 on guidelines for the accommodation and care of animals used for experimental and other scientific purposes (notified under document number C(2007) 2525).

Owen, 1997, Report on primate supply for biomedical scientific work in the UK. EUPREN UK working party, Lab. Anim., 31, 289, 10.1258/002367797780596149

Pastori, F., Salerno, D., Oberto, G., Villa, S., Ricci, R., Calfapierta, F.R., 2010. Comparison and validation of Dried Blood Spot (DBS) and Solid Phase Extraction (SPE) techniques. In: XII International Congress of Toxicology. Toxicol. Lett. 196S, Barcelona, Spain.

Peretta, 2009, Non-human primate models in neuroscience research, Scand. J. Lab. Anim. Sci., 36, 77

Ramaswamy, 2007, Animal models of Huntington’s disease, ILAR J., 48, 356, 10.1093/ilar.48.4.356

Reddy, 1983, Chemical carcinogens without mutagenic activity: peroxisome proliferators as a prototype, Toxicol. Pathol., 11, 172, 10.1177/019262338301100209

Riecke, 2000, Cross-reactivity of antibodies on thymic epithelial cells from humans and marmosets by flow-cytometry, J. Med. Primatol., 29, 343, 10.1034/j.1600-0684.2000.290506.x

Ross, 2007, Germ-line chimerism and paternal care in marmosets (Callithrix kuhlii), Proc. Natl Acad. Sci. USA, 104, 6278, 10.1073/pnas.0607426104

Ruiz de Elvira, 1986, A backpack system for long-term osmotic minipump infusions into unrestrained marmoset monkeys, Lab. Anim., 20, 329, 10.1258/002367786780808811

Rumrill, 2009, Multiple sclerosis: medical and psychosocial aspects, etiology, incidence, and prevalence, J. Voc. Rehabil., 31, 75, 10.3233/JVR-2009-476

Sakuma, 1997, Marmoset CYP1A2: primary structure and constitutive expression in livers, Carcinogenesis, 18, 1985, 10.1093/carcin/18.10.1985

Sasaki, 2009, Generation of transgenic non-human primates with germline transmission, Nature, 459, 523, 10.1038/nature08090

SCHER, 2009. The need for non human primates for biomedical research, production and testing of products and devices. European Commission. pp. 1–36.

Schnell, 1995, Measurement of blood pressure and heart rate by telemetry in conscious unrestrained marmosets, Lab. Anim., 29, 258, 10.1258/002367795781088180

Sharpe, 2002, Infant feeding with soy formula milk: effects on the testis and on blood testosterone levels in marmoset monkeys during the period of neonatal testicular activity, Hum. Reprod., 17, 1692, 10.1093/humrep/17.7.1692

Shimada, 1994, Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians, J. Pharmacol. Exp. Ther., 270, 414

Smith, 2001, The selection of marmoset monkeys (Callithrix jacchus) in pharmaceutical toxicology, Lab. Anim., 35, 117, 10.1258/0023677011911444

Soars, 2001, Evaluation of the marmoset as a model species for drug glucuronidation, Xenobiotica, 31, 849, 10.1080/00498250110069690

Spencer, 1989, Gastric morphological changes including carcinoid tumors in animals treated with a potent hypolipidemic agent, ciprofibrate, Toxicol. Pathol., 17, 7, 10.1177/01926233890171P102

Summers, 1987, The effects of cryopreservation and transfer on embryonic development in the common marmoset monkey, Callithrix jacchus, J. Reprod. Fertil., 79, 241, 10.1530/jrf.0.0790241

t Hart, 2005, Suppression of ongoing disease in a nonhuman primate model of multiple sclerosis by a human-anti-human IL-12p40 antibody, J. Immunol., 175, 4761, 10.4049/jimmunol.175.7.4761

t Hart, 2009, Clinical, pathological, and immunologic aspects of the multiple sclerosis model in common marmosets (Callithrix jacchus), J. Neuropathol. Exp. Neurol., 68, 341, 10.1097/NEN.0b013e31819f1d24

t Hart, 2000, A new primate model for multiple sclerosis in the common marmoset, Immunol. Today, 21, 290, 10.1016/S0167-5699(00)01627-3

Tan, 2006, Infant feeding with soy formula milk: effects on puberty progression, reproductive function and testicular cell numbers in marmoset monkeys in adulthood, Hum. Reprod., 21, 896, 10.1093/humrep/dei421

Tucker, 1984, A survey of the pathology of marmosets (Callithrix jacchus) under experiment, Lab. Anim., 18, 351, 10.1258/002367784780865397

Wadsworth, 1981, Organ weight data in juvenile and adult marmosets (Callithrix jacchus), Lab. Anim., 15, 385, 10.1258/002367781780952816

Weatherall, 2006

Williams, 2004, Defining relationships between the known members of the cytochrome P450 3A subfamily, including five putative chimpanzee members, Mol. Phylogen. Evol., 33, 300, 10.1016/j.ympev.2004.05.013

Zuhlke, 2003, The common marmoset (Callithrix jacchus) as a model in toxicology, Toxicol. Pathol., 31, 123, 10.1080/01926230390175002