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https://www.readbyqxmd.com/read/28734646/quantitative-prediction-of-therapeutic-antibody-pharmacokinetics-after-intravenous-and-subcutaneous-injection-in-human
#1
Kenta Haraya, Tatsuhiko Tachibana, Junichi Nezu
Prediction of the plasma/serum mAb concentration-time profile in human is important to determine the required dose regime. This study proposes an approach for predicting the plasma/serum mAb concentration-time profile after intravenous and subcutaneous injection in human based on comprehensive analysis of reported pharmacokinetic data. Optimal scaling exponents from cynomolgus monkey to human for CL, Q, Vc, and Vp were estimated as 0.8, 0.75, 1.0, and 0.95, respectively. The estimated exponents were used to predict plasma/serum mAb concentration-time profile in human from pharmacokinetic data in cynomolgus monkey, and the results had reasonable accuracy with symmetric variability of prediction...
May 29, 2017: Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28731212/cross-validation-of-commercial-enzyme-linked-immunosorbent-assay-and-radioimmunoassay-for-porcine-c-peptide-concentration-measurements-in-non-human-primate-serum
#2
Sarah C Gresch, Lucas A Mutch, Jody L Janecek, Rebecca L Hegstad-Davies, Melanie L Graham
BACKGROUND: C-peptide concentration is widely used as a marker of insulin secretion and is especially relevant in evaluating islet graft function following transplantation, because its measurement is not confounded by the presence of exogenous insulin. To address the shortage of human islet donors, the use of porcine islets has been proposed as a possible solution and the stringent pig-to-non-human primate (NHP) model is often the most relevant for pre-clinical evaluation of the potential for diabetes reversal resulting from an islet xenograft...
July 21, 2017: Xenotransplantation
https://www.readbyqxmd.com/read/28728590/chikungunya-virus-infection-in-cynomolgus-macaques-following-intradermal-and-aerosol-exposure
#3
Chris M Cirimotich, Eric M Vela, Jennifer Garver, Roy E Barnewall, Brian D Miller, Gabriel T Meister, James V Rogers
BACKGROUND: Chikungunya virus (CHIKV) is transmitted via mosquito bite and potentially by aerosol, causing chikungunya fever and arthritic disease in humans. There are currently no licensed vaccines or antiviral therapeutics to protect against CHIKV infection in humans. Animal models recapitulating human disease, especially for transmission by aerosol, are needed for licensure of such medical countermeasures. METHODS: Cynomolgus macaques (CMs) were challenged by intradermal (ID) inoculation or exposure to an aerosol containing CHIKV Ross strain at different target infectious doses (10(3)-10(7) plaque forming units (PFU))...
July 20, 2017: Virology Journal
https://www.readbyqxmd.com/read/28719653/isolation-of-a-monoclonal-antibody-from-a-phage-display-library-binding-the-rhesus-macaque-mhc-class-i-allomorph-mamu-a1-001
#4
Nathan Holman, Jason T Weinfurter, Trevor R Harsla, Roger W Wiseman, Aaron J Belli, Anthony J Michaels, Keith A Reimann, Robert I DeMars, Matthew R Reynolds
Monoclonal antibodies that bind to human leukocyte antigen (HLA) are useful tools for HLA-typing, tracking donor-recipient chimerisms after bone marrow transplants, and characterizing specific major histocompatibility complexes (MHC) on cell surfaces. Unfortunately, equivalent reagents are not available for rhesus macaques, which are commonly used animal as models in organ transplant and infectious disease research. To address this deficiency, we isolated an antibody that recognizes the common Indian rhesus macaque MHC class I molecule, Mamu-A1*001...
2017: PloS One
https://www.readbyqxmd.com/read/28717098/evaluation-of-drug-induced-hematotoxicity-using-novel-in-vitro-monkey-cfu-gm-and-bfu-e-colony-assays
#5
Koichi Goto, Mayumi Goto, Masako Ando-Imaoka, Kiyonori Kai, Kazuhiko Mori
In order to evaluate drug-induced hematotoxicity in monkey cells in vitro, colony-forming unit-granulocyte, macrophage (CFU-GM), and burst-forming unit-erythroid (BFU-E) colony assays were established using mononuclear cells in the bone marrow collected from male cynomolgus monkeys. Furthermore, the effects of doxorubicin, chloramphenicol, and linezolid on CFU-GM and BFU-E colony formation were investigated using established monkey CFU-GM and BFU-E colony assays in comparison with those on human CFU-GM and BFU-E colonies acquired from human umbilical cord blood cells...
2017: Journal of Toxicological Sciences
https://www.readbyqxmd.com/read/28689458/marmoset-pulmonary-cytochrome-p450-2f1-oxidizes-biphenyl-and-7-ethoxycoumarin-and-hepatic-human-p450-substrates
#6
Shotaro Uehara, Yasuhiro Uno, Toru Oshio, Takashi Inoue, Erika Sasaki, Hiroshi Yamazaki
1. A potentially useful animal model for preclinical studies is the common marmoset (Callithrix jacchus). In this study, using reverse-transcription polymerase chain reaction from marmoset livers, we identified a novel cytochrome P450 (P450) 2F1 cDNA with an open reading frame of 1473 bp. 2. High sequence identities of 92-94% with primate P450 2F amino acid sequences were indicated by deduced amino acid sequences of P450 2F1 cDNA. Phylogenetic analysis indicates that marmoset P450 2F1 is more congruent with primate P450 2F forms than those of other species such as rodents...
July 8, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28682477/preclinical-safety-and-efficacy-of-andexanet-alfa-in-animal-models
#7
G Lu, S J Hollenbach, D C Baker, S Tan, A Hutchaleelaha, J T Curnutte, P B Conley
BACKGROUND: Andexanet is a recombinant modified form of factor Xa (FXa), designed to bind to and reverse the anticoagulant activity of FXa inhibitors. OBJECTIVES: To evaluate the ability of andexanet to reverse the anticoagulant activity of rivaroxaban, and assess its pharmacokinetics (PK) and toxicity in animal models. METHODS: The effects of andexanet on blood loss, anti-FXa activity, rivaroxaban unbound plasma concentrations, and other coagulation parameters were assessed in a rabbit liver laceration 'treatment' model...
July 6, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28674309/pathogenic-analysis-of-the-pandemic-2009-h1n1-influenza-a-viruses-in-ferrets
#8
Yoshimi Tsuda, Carla Weisend, Cynthia Martellaro, Friederike Feldmann, Elaine Haddock
The pandemic 2009 H1N1 influenza A virus emerged in humans and caused the first influenza pandemic of the 21st century. Mexican isolates, A/Mexico/4108/2009 (H1N1) (Mex4108) and A/Mexico/InDRE4478/2009 (H1N1) (Mex4487) derived from a mild case and from a cluster of severe cases, showed heterogeneity in virulence in a cynomolgus macaque model. To compare the more pathogenic differences, we generated recombinant viruses and compared their virulence in ferrets. Ferrets infected with recombinant Mex4487 displayed a slightly higher rate of viral replication and severe pneumonia in the early stage of infection...
July 3, 2017: Journal of Veterinary Medical Science
https://www.readbyqxmd.com/read/28671847/identification-and-optimization-of-pyrrolo-3-2-d-pyrimidine-toll-like-receptor-7-tlr7-selective-agonists-for-the-treatment-of-hepatitis-b
#9
David Craig McGowan, Florence Herschke, Frederik Pauwels, Bart Stoops, Ilham Smyej, Stefaan Last, Serge Pieters, Werner Embrechts, Mourad Daoubi Khamlichi, Tine Thoné, Bertrand Van Schoubroeck, Wendy Mostmans, Debbie Wuyts, Dorien Verstappen, Annick Scholliers, Dorien De Pooter, Deborah Dhuyvetter, Herman Borghys, Marianne Tuefferd, Eric Arnoult, Jin Hong, Gregory Fanning, Jacques Bollekens, Vijay Urmaliya, Ard Teisman, Helen Horton, Tim H M Jonckers, Pierre Jean Marie Bernard Raboisson
Pyrrolo[3,2-d]pyrimidines were identified as a new series of potent and selective TLR7 agonists. Compounds were optimized for their activity and selectivity over TLR8. This presents an advantage over recently described scaffolds that have residual TLR8 activity, which may be detrimental to the tolerability of the candidate drug. Oral administration of the lead compound 54 effectively induced a transient interferon stimulated gene (ISG) response in mice and cynomolgus monkeys. We aimed for a high first pass effect, limiting cytokine induction systemically, and demonstrated the potential for the immunotherapy of viral hepatitis...
July 3, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28664555/hepatic-expression-of-cytochrome-p450-enzymes-in-non-human-primate-species
#10
Shotaro Uehara, Yasuhiro Uno, Hiroshi Yamazaki
Cytochromes P450 (P450) largely remain to be characterized in great apes. Comparative immunochemical detection of drug metabolizing forms of P450s 1A, 2A, 2B, 2C, 2D, 2E, 2J, 3A, 4A, and 4F in liver microsomes from chimpanzees, gorillas, orangutans, gibbons, cynomolgus and rhesus macaques, and common marmosets were carried out.
June 29, 2017: Journal of Medical Primatology
https://www.readbyqxmd.com/read/28649393/single-cell-transcriptome-of-early-embryos-and-cultured-embryonic-stem-cells-of-cynomolgus-monkeys
#11
Tomonori Nakamura, Yukihiro Yabuta, Ikuhiro Okamoto, Kotaro Sasaki, Chizuru Iwatani, Hideaki Tsuchiya, Mitinori Saitou
In mammals, the development of pluripotency and specification of primordial germ cells (PGCs) have been studied predominantly using mice as a model organism. However, divergences among mammalian species for such processes have begun to be recognized. Between humans and mice, pre-implantation development appears relatively similar, but the manner and morphology of post-implantation development are significantly different. Nevertheless, the embryogenesis just after implantation in primates, including the specification of PGCs, has been unexplored due to the difficulties in analyzing the embryos at relevant developmental stages...
2017: Scientific Data
https://www.readbyqxmd.com/read/28642489/post-exposure-treatment-of-non-human-primates-lethally-infected-with-ebola-virus-with-ebotab-a-purified-ovine-igg-product
#12
Stuart D Dowall, Frédéric Jacquot, John Landon, Emma Rayner, Graham Hall, Caroline Carbonnelle, Hervé Raoul, Delphine Pannetier, Ian Cameron, Ruth Coxon, Ibrahim Al Abdulla, Roger Hewson, Miles W Carroll
Despite sporadic outbreaks of Ebola virus (EBOV) over the last 4 decades and the recent public health emergency in West Africa, there are still no approved vaccines or therapeutics for the treatment of acute EBOV disease (EVD). In response to the 2014 outbreak, an ovine immunoglobulin therapy was developed, termed EBOTAb. After promising results in the guinea pig model of EBOV infection, EBOTAb was tested in the cynomolgus macaque non-human primate model of lethal EBOV infection. To ensure stringent therapeutic testing conditions to replicate likely clinical usage, EBOTAb was first delivered 1, 2 or 3 days post-challenge with a lethal dose of EBOV...
June 22, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28625601/role-of-social-interaction-exercise-diet-and-age-on-developing-and-untreated-diabetes-in-cynomolgus-monkeys
#13
Feng Yue, Guodong Zhang, Jorge E Quintero, Don M Gash, Zhiming Zhang
Type 2 diabetes mellitus is the most common form of diabetes that occurs in both human and nonhuman primates. Although spontaneously diabetic nonhuman primates are used extensively in diabetic related research and are a proven valuable tool for the study of the natural history of diabetes, little is known about the key factors that can cause this metabolic disorder and the preventative measures that could be employed to minimize the consequences of diabetes. Using a model of developing and untreated diabetes, this study describes the effects of housing arrangement (socially group- versus individually single-housed), exercise, diet, age, and sex on fasting plasma glucose, key lipids associated with diabetes, and bodyweight in two large cohorts of nonhuman primates...
June 15, 2017: Experimental Gerontology
https://www.readbyqxmd.com/read/28624430/comparative-assessment-of-immune-complex-mediated-hypersensitivity-reactions-with-biotherapeutics-in-the-non-human-primate-critical-parameters-safety-and-lessons-for-future-studies
#14
Sven Kronenberg, Elisabeth Husar, Christine Schubert, Christian Freichel, Thomas Emrich, Martin Lechmann, Anna Maria Giusti, Franziska Regenass
With the emergence of novel biotherapeutic formats and immunostimulatory biotherapeutics in cancer immunotherapy, an understanding of immune-complex (IC) mediated hypersensitivity reactions in toxicology studies - and their differentiation from pharmacology - remains key to the preclinical evaluation of these drugs. In this review we provide an in-depth evaluation and comparison of case examples where IC-mediated hypersensitivity reactions were observed in cynomolgus monkeys. We provide details of the parameters evaluated in each study to substantiate and guide the interpretation of these findings...
June 15, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28619366/bpi-3016-a-novel-long-acting-hglp-1-analogue-for-the-treatment-of-type-2-diabetes-mellitus
#15
Lieming Ding, Sisi Lu, Yanping Wang, Haibo Chen, Wei Long, Cunbo Ma, Erlong He, Dan Yan, Fenlai Tan
Glucagon-like peptide-1 (GLP-1) analogues have been commonly used as add-on medications for patients with Type 2 diabetes mellitus (T2DM). Currently, the development of long-acting GLP-1 analogues which allow the freedom and flexibility of once-weekly injections while maintaining their potency for a relatively long period has become the mainstream. Here, we successfully developed a long-acting human GLP-1(7-37) analogue (BPI-3016) with significantly extended half-life and increased resistance to dipeptidyl peptidase IV (DPP-IV) cleavage by structural modifications of human GLP-1...
August 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28610792/quantitative-and-qualitative-inkt-repertoire-associations-with-disease-susceptibility-and-outcome-in-macaque-tuberculosis-infection
#16
Andrew Chancellor, Andrew White, Anna S Tocheva, Joe R Fenn, Mike Dennis, Liku Tezera, Akul Singhania, Tim Elliott, Marc Tebruegge, Paul Elkington, Stephan Gadola, Sally Sharpe, Salah Mansour
Correlates of immune protection that reliably predict vaccine efficacy against Mycobacterium tuberculosis (Mtb) infection are urgently needed. Invariant NKT cells (iNKTs) are CD1d-dependent innate T cells that augment host antimicrobial immunity through production of cytokines, including interferon (IFN)-γ and tumour necrosis factor (TNF)-α. We determined peripheral blood iNKT numbers, their proliferative responses and iNKT subset proportions after in vitro antigen expansion by α-galactosylceramide (αGC) in a large cohort of mycobacteria-naïve non-human primates, and macaques from Bacillus Calmette-Guerin (BCG) vaccine and Mtb challenge studies...
July 2017: Tuberculosis
https://www.readbyqxmd.com/read/28609387/long-term-sertraline-treatment-and-depression-effects-on-carotid-artery-atherosclerosis-in-premenopausal-female-primates
#17
Marnie G Silverstein-Metzler, Jamie N Justice, Susan E Appt, Leanne Groban, Dalane W Kitzman, John Jeffrey Carr, Thomas C Register, Carol A Shively
OBJECTIVE: Atherosclerosis developed during premenopausal years predicts postmenopausal atherosclerosis burden. Selective serotonin reuptake inhibitor (SSRI) antidepressants, recently approved for hot flushes, have been associated with increased ischemic stroke risk in several observational studies; however, effects on carotid artery atherosclerosis, a strong predictor of future vascular events, are unknown. METHODS: The effects of chronic administration of a commonly prescribed SSRI, sertraline HCl, on atherosclerosis in the carotid artery was assessed in a placebo-controlled, longitudinal, randomized study of premeonopausal depressed and nondepressed cynomolgus monkeys (Macaca fascicularis; n = 42)...
June 12, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28608515/efavirenz-clearances-in-vitro-and-in-vivo-in-six-cynomolgus-monkeys-associated-with-polymorphic-cytochrome-p450-2c9-and-simulated-by-individual-physiologically-based-pharmacokinetic-models
#18
Masahiro Utoh, Tomonori Miura, Takashi Kusama, Shotaro Uehara, Makiko Shimizu, Yasuhiro Uno, Hiroshi Yamazaki
Cynomolgus monkey cytochrome P450 2C9 (formerly known as P450 2C43) variation was reportedly associated with metabolic clearance of the antiretroviral drug efavirenz in vivo (of three wild-type, one heterozygote, and two homozygote animals), being unlikely in the case of human P450 2B6-dependent efavirenz clearance. In this study, the liver microsomal elimination rates of efavirenz for the same individual animals previously treated with intravenous/oral administrations of efavirenz showed significant reductions associated with the P450 2C9 p...
June 13, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28608008/effects-of-social-reorganization-on-dopamine-d2-d3-receptor-availability-and-cocaine-self-administration-in-male-cynomolgus-monkeys
#19
P W Czoty, R W Gould, H D Gage, M A Nader
RATIONALE: Studies have demonstrated that brain dopamine D2/D3 receptors (D2/D3R) and the reinforcing effects of cocaine can be influenced by a monkey's position in the social dominance hierarchy. OBJECTIVE: In this study, we manipulated the social ranks of monkeys by reorganizing social groups and assessed effects on D2/D3R availability and cocaine self-administration. METHODS: Male cynomolgus monkeys (N = 12) had been trained to self-administer cocaine under a concurrent cocaine-food reinforcement schedule...
June 12, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28601605/rapid-focal-cooling-attenuates-cortical-seizures-in-a-primate-epilepsy-model
#20
Guoping Ren, Jiaqing Yan, Guoxian Tao, Yunmeng Gan, Donghong Li, Xi Yan, Yongjuan Fu, Leiming Wang, Weimin Wang, Zhiming Zhang, Feng Yue, Xiaofeng Yang
Rapid focal cooling is an attractive nondestructive strategy to control and possibly prevent focal seizures. However, the temperature threshold necessary to abort seizures in primates is still unknown. Here, we explored this issue in a primate epilepsy model and observed the effect of rapid cooling on different electroencephalogram frequency bands, aiming at providing necessary experimental data for future clinical translational studies and exploring the mechanism of focal cooling in terminating seizures. We induced focal neocortical seizures using microinjection of 4-aminopyridine into premotor cortex in five anesthetized cynomolgus monkeys...
June 7, 2017: Experimental Neurology
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