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https://www.readbyqxmd.com/read/27911357/characterization-of-metabolic-status-in-nonhuman-primates-with-the-intravenous-glucose-tolerance-test
#1
Michael Staup, George Aoyagi, TeQuana Bayless, Yixin Wang, Keefe Chng
The intravenous glucose tolerance test (IVGTT) plays a key role in the characterization of glucose homeostasis. When taken together with serum biochemical profiles, inclusive of blood glucose levels in both the fed and fasted state, HbA1c, insulin levels, clinical history of diet, body composition, and body weight status, an assessment of normal and abnormal glycemic control can be made. Interpretation of an IVGTT is done through measurement of changes in glucose and insulin levels over time in relation to the dextrose challenge...
November 13, 2016: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/27910264/vaccination-against-h9n2-avian-influenza-virus-reduces-bronchus-associated-lymphoid-tissue-formation-in-cynomolgus-macaques-after-intranasal-virus-challenge-infection
#2
Misako Nakayama, Hiroichi Ozaki, Yasushi Itoh, Kosuke Soda, Hirohito Ishigaki, Masatoshi Okamatsu, Yoshihiro Sakoda, Chun-Ho Park, Hideaki Tsuchiya, Hiroshi Kida, Kazumasa Ogasawara
H9N2 avian influenza virus causes sporadic human infection. Since humans do not possess acquired immunity specific to this virus, we examined the pathogenicity of an H9N2 virus isolated from a human and then analyzed protective effects of a vaccine in cynomolgus macaques. After intranasal challenge with A/Hong Kong/1073/1999 (H9N2) (HK1073) isolated from a human patient, viruses were isolated from nasal and tracheal swabs in unvaccinated macaques with mild fever and body weight loss. A formalin-inactivated H9N2 whole particle vaccine derived from our virus library was subcutaneously inoculated to macaques...
December 2016: Pathology International
https://www.readbyqxmd.com/read/27908992/first-complete-genome-sequence-of-a-simian-foamy-virus-isolate-from-a-cynomolgus-macaque
#3
Koji Sakai, Yasushi Ami, Yuriko Suzaki, Tetsuro Matano
We report here the first complete proviral genome sequence (DDBJ/ENA/GenBank accession no. LC094267) of a simian foamy virus, SFVmfa/Cy5061, isolated from a cynomolgus macaque (Macaca fascicularis). This proviral genome consists of 12,965 nucleotides and has five open reading frames, gag, pol, env, tas, and bet, as with other foamy viruses.
December 1, 2016: Genome Announcements
https://www.readbyqxmd.com/read/27902767/towards-a-non-human-primate-model-of-alpha-synucleinopathy-for-development-of-therapeutics-for-parkinson-s-disease-optimization-of-aav1-2-delivery-parameters-to-drive-sustained-expression-of-alpha-synuclein-and-dopaminergic-degeneration-in-macaque
#4
James B Koprich, Tom H Johnston, Gabriela Reyes, Vanessa Omana, Jonathan M Brotchie
Recent failures in clinical trials for disease modification in Parkinson's disease have highlighted the need for a non-human primate model of the synucleinopathy underpinning dopaminergic neuron degeneration. The present study was defined to begin the development of such a model in cynomolgus macaque. We have validated surgical and vector parameters to define a means to provide a robust over-expression of alpha-synuclein which is associated with Lewy-like pathology and robust degeneration of the nigrostriatal pathway...
2016: PloS One
https://www.readbyqxmd.com/read/27902330/simian-immunodeficiency-virus-sivmac239-infection-and-simian-human-immunodeficiency-virus-shiv89-6p-infection-result-in-progression-to-aids-in-cynomolgus-macaques-from-asian-country-origin
#5
Tomotaka Okamura, Yusuke Tsujimura, Shogo Soma, Ichiro Takahashi, Kazuhiro Matsuo, Yasuhiro Yasutomi
Simian immunodeficiency virus (SIV) infection models in cynomolgus macaques are important for analysis of the pathogenesis of immunodeficiency virus and for studies on the efficacy of new vaccine candidates. However, very little is known about the pathogenesis of SIV or simian human immunodeficiency virus (SHIV) in cynomolgus macaques from different Asian country origins. In the present study, we analyzed the infectivity and pathogenicity of CCR5-tropic SIVmac and those of dual-tropic SHIV89.6P inoculated in cynomolgus macaques of Indonesia, Malaysia or Philippines origin...
October 21, 2016: Journal of General Virology
https://www.readbyqxmd.com/read/27900576/time-course-behavioral-safety-and-protective-efficacy-of-centrally-active-reversible-acetylcholinesterase-inhibitors-in-cynomolgus-macaques
#6
Lindsey R Hamilton, Steven C Schachter, Todd M Myers
Galantamine hydrobromide and (-)huperzine A, centrally active reversible acetylcholinesterase inhibitors, are potentially superior to the current standard, pyridostigmine bromide, as a pretreatment for organophosphorus chemical warfare nerve agent intoxication. Galantamine, huperzine, and pyridostigmine were compared for time course of acetylcholinesterase inhibition in 12 cynomolgus macaques. Although both galantamine and huperzine shared a similar time course profile for acetylcholinesterase inhibition, huperzine was 88 times more potent than galantamine...
November 30, 2016: Neurochemical Research
https://www.readbyqxmd.com/read/27899229/development-of-novel-replication-defective-lymphocytic-choriomeningitis-virus-vectors-expressing-siv-antigens
#7
Pablo Penaloza MacMaster, Jennifer L Shields, Quazim A Alayo, Crystal Cabral, Jessica Jimenez, Jade Mondesir, Abishek Chandrashekar, Joseph M Cabral, Matthew Lim, M Justin Iampietro, Nicholas M Provine, Christine A Bricault, Michael Seaman, Klaus Orlinger, Andreas Aspoeck, Gerhard Fuhrmann, Anders E Lilja, Thomas Monath, Bastien Mangeat, Daniel D Pinschewer, Dan H Barouch
An important focus in vaccine research is the design of vaccine vectors with low seroprevalence and high immunogenicity. Replication-incompetent lymphocytic choriomeningitis virus (rLCMV) vectors do not elicit vector-neutralizing antibody responses, and homologous prime-boost regimens with rLCMV vectors induce boostable and protective T cell responses to model antigens in mice. However, cellular and humoral immune responses following homologous rLCMV vaccine regimens have not been rigorously evaluated in non-human primates (NHPs)...
November 26, 2016: Vaccine
https://www.readbyqxmd.com/read/27889562/systematic-evaluation-of-monoclonal-antibodies-and-immunoassays-for-the-detection-of-interferon-%C3%AE-and-interleukin-2-in-old-and-new-world-non-human-primates
#8
Ankie Höglind, Irene Areström, Cecilia Ehrnfelt, Khosro Masjedi, Bartek Zuber, Luis Giavedoni, Niklas Ahlborg
Non-human primates (NHP) provide important animal models for studies on immune responses to infections and vaccines. When assessing cellular immunity in NHP, cytokines are almost exclusively analyzed utilizing cross-reactive anti-human antibodies. The functionality of antibodies has to be empirically established for each assay/application as well as NHP species. A rational approach was employed to identify monoclonal antibodies (mAb) cross-reactive with many NHP species. Panels of new and established mAbs against human Interferon (IFN)-γ and Interleukin (IL)-2 were assessed for reactivity with eukaryotically expressed recombinant IFN-γ and IL-2, respectively, from Old (rhesus, cynomolgus and pigtail macaques, African green monkey, sooty mangabey and baboon) and New World NHP (Ma's night monkey, squirrel monkey and common marmoset)...
November 23, 2016: Journal of Immunological Methods
https://www.readbyqxmd.com/read/27886524/effects-of-ethanol-on-cocaine-self-administration-in-monkeys-responding-under-a-second-order-schedule-of-reinforcement
#9
William S John, Michael A Nader
BACKGROUND: Concurrent alcohol use among cocaine abusers is common but the behavioral variables that promote co-abuse are not well understood. The present study examined the effects of intragastric (i.g.) ethanol (EtOH) administration in monkeys responding under a schedule of cocaine reinforcement in which extensive drug seeking was maintained by conditioned stimuli. METHODS: Four adult male cynomolgus monkeys (Macaca fascicularis) were trained to respond under a second-order fixed-interval (FI) 600s (fixed-ratio (FR) 30:S) schedule of cocaine (0...
November 10, 2016: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/27884079/bypassing-nonparallelism-of-a-monoclonal-antibody-ligand-binding-assay-by-employment-of-alternative-assay-formats
#10
Stefan Kiesgen, Armin Schröder, Thomas Schwarz, Oliver Czupalla, Manuela Braun, Mark Jean Gnoth, Joanna Grudzinska-Goebel
Determination of concentration-time profiles in cynomolgus monkeys of a therapeutic monoclonal antibody against a soluble target revealed a substantial discrepancy between a generic anti-human IgG capture/detection and target bridging assay with the target bridging assay leading to dose- and time-dependent underquantification of drug concentrations, lack of parallelism and subsequently different pharmacokinetic parameters. In contrast, plasma levels derived from a target capture and an anti-idiotypic antibody bridging assay were in close concordance with the generic assay and demonstrated parallelism with high precision across several dilutions...
December 2016: Bioanalysis
https://www.readbyqxmd.com/read/27881707/a-cd80-biased-ctla4-ig-fusion-protein-with-superior-in-vivo-efficacy-by-simultaneous-engineering-of-affinity-selectivity-stability-and-fcrn-binding
#11
Julie Douthwaite, Jacques Moisan, Cyril Privezentzev, Blagoje Soskic, Shereen Sabbah, Suzanne Cohen, Andie Collinson, Elizabeth England, Catherine Huntington, Ben Kemp, Li Zhuang, Suzanne Hudak, D Gareth Rees, Debbie Goldberg, Chris Barton, Linda Chang, Inna Vainshtein, Meina Liang, Laurie Iciek, Philip Ambery, Mark Peakman, Tristan J Vaughan, Tim I M Tree, David M Sansom, Michael A Bowen, Ralph R Minter, Lutz Jermutus
Affinity- and stability-engineered variants of CTLA4-Ig fusion molecules with enhanced pharmacokinetic profiles could yield improved therapies with the potential of higher efficacy and greater convenience to patients. In this study, to our knowledge, we have, for the first time, used in vitro evolution to simultaneously optimize CTLA4 affinity and stability. We selected for improved binding to both ligands, CD80 and CD86, and screened as dimeric Fc fusions directly in functional assays to identify variants with stronger suppression of in vitro T cell activation...
November 23, 2016: Journal of Immunology: Official Journal of the American Association of Immunologists
https://www.readbyqxmd.com/read/27879438/a-comparison-of-rodent-and-nonrodent-laryngeal-and-tracheal-bifurcation-sensitivities-in-inhalation-toxicity-studies-and-their-relevance-for-human-exposure
#12
Vasanthi Mowat, David J Alexander, Andrew M Pilling
In inhalation toxicity studies, drug-induced lesions are frequently reported in the larynx and sometimes at the tracheal bifurcation (carina) in the rat, but less so in the dog or monkey, bringing into question the relevance of these rodent findings for humans. The rat larynx is widely considered to be more sensitive than that of the dog and monkey in its response to inhaled xenobiotics, although we could find no published data to support this. In this review, data from 52 inhalation studies involving rodent and nonrodent species were collated and reviewed...
November 22, 2016: Toxicologic Pathology
https://www.readbyqxmd.com/read/27879436/cytological-bone-marrow-cell-differential-counts-and-morphologic-findings-in-healthy-cynomolgus-monkeys-macaca-fascicularis-from-nonclinical-toxicology-studies
#13
Caitlyn M Carter, Laura C Cregar, Adam D Aulbach
Cytological bone marrow evaluation is utilized in nonclinical toxicology studies to characterize hematopoietic effects when the combined interpretation of histologic and complete blood count data does not yield sufficient information. Results from cytological bone marrow examination should be interpreted in the context of variability observed in concurrent control animals with consideration of cytologist experience and historical/published data. Cytological bone marrow differential counts and cellular morphologic findings from 130 (66 male, 64 female) healthy control cynomolgus monkeys from nonclinical toxicology studies were retrospectively analyzed...
November 22, 2016: Toxicologic Pathology
https://www.readbyqxmd.com/read/27879435/identification-of-mhc-haplotypes-associated-with-drug-induced-hypersensitivity-reactions-in-cynomolgus-monkeys
#14
Hong Wu, Jessica Whritenour, Jonathan C Sanford, Christopher Houle, Karissa K Adkins
Drug-induced hypersensitivity reactions can significantly impact drug development and use. Studies to understand risk factors for drug-induced hypersensitivity reactions have identified genetic association with specific human leukocyte antigen (HLA) alleles. Interestingly, drug-induced hypersensitivity reactions can occur in nonhuman primates; however, association between drug-induced hypersensitivity reactions and major histocompatibility complex (MHC) alleles has not been described. In this study, tissue samples were collected from 62 cynomolgus monkeys from preclinical studies in which 9 animals had evidence of drug-induced hypersensitivity reactions...
November 22, 2016: Toxicologic Pathology
https://www.readbyqxmd.com/read/27873117/mitigation-of-pre-existing-antibodies-to-a-biotherapeutic-in-non-clinical-species-when-establishing-anti-drug-antibody-assay-cutpoint
#15
Seema C Kumar, Jason A DelCarpini, Qiang Qu, Martin Kane, Boris Gorovits
Biotherapeutics are known for their potential to induce drug specific immune responses, which are commonly evaluated by the detection of anti-drug antibodies (ADAs). For some biotherapeutics, pre-existing ADAs against drug have been observed in drug-naïve matrix. The presence of pre-existing drug specific antibodies may significantly complicate assessment of the screening ADA assay cutpoint value, which is usually established based on the statistical analysis of signal distribution from the drug-naïve individuals...
November 21, 2016: AAPS Journal
https://www.readbyqxmd.com/read/27872236/preclinical-and-early-clinical-profile-of-a-highly-selective-and-potent-oral-inhibitor-of-aldosterone-synthase-cyp11b2
#16
Katrijn Bogman, Dietmar Schwab, Marie-Laure Delporte, Giuseppe Palermo, Kurt Amrein, Susanne Mohr, Maria Cristina De Vera Mudry, Morris J Brown, Philippe Ferber
Primary hyperaldosteronism is a common cause of resistant hypertension. Aldosterone is produced in the adrenal by aldosterone synthase (AS, encoded by the gene CYP11B2). AS shares 93% homology to 11β-hydroxylase (encoded by the gene CYP11B1), responsible for cortisol production. This homology has hitherto impeded the development of a drug, which selectively suppresses aldosterone but not cortisol production, as a new treatment for primary hyperaldosteronism. We now report the development of RO6836191 as a potent (Ki 13 nmol/L) competitive inhibitor of AS, with in vitro selectivity >100-fold over 11β-hydroxylase...
November 21, 2016: Hypertension
https://www.readbyqxmd.com/read/27865001/romosozumab-improves-bone-mass-and-strength-while-maintaining-bone-quality-in-ovariectomized-cynomolgus-monkeys
#17
Michael S Ominsky, Steven K Boyd, Aurore Varela, Jacquelin Jolette, Melanie Felx, Nancy Doyle, Nacera Mellal, Susan Y Smith, Kathrin Locher, Sabina Buntich, Ian Pyrah, Rogely W Boyce
Romosozumab (Romo), a humanized sclerostin antibody, is a bone-forming agent under development for treatment of osteoporosis. To examine the effects of Romo on bone quality, mature cynomolgus monkeys (cynos) were treated 4 months post-ovariectomy (OVX) with vehicle, 3, or 30 mg/kg Romo for 12 months, or with 30 mg/kg Romo for 6 months followed by vehicle for 6 months (30/0). Serum bone formation markers were increased by Romo during the first 6 months, corresponding to increased cancellous, endocortical, and periosteal bone formation in rib and iliac biopsies at months 3 and 6...
November 10, 2016: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/27864544/investigative-nonclinical-cardiovascular-safety-and-toxicology-studies-with-bms-986094-an-ns5b-rna-dependent-rna-polymerase-inhibitor
#18
M Gill, K Horn, J Hennan, R White, D Bounous, S Clark, J R Megill, E Janovitz, M Davies, T Sanderson, M Graziano
BMS-986094, a 2'-C-methylguanosine prodrug that was in development for treatment of chronic hepatitis C infection was withdrawn from Phase 2 clinical trials because of unexpected cardiac and renal adverse events. Investigative nonclinical studies were conducted to extend the understanding of these findings using more comprehensive endpoints. BMS-986094 was given orally to female CD-1 mice (25 and 150 mg/kg/d) for 2 weeks (53/group) and to cynomolgus monkeys (15 and 30 mg/kg/d) for up to 6 weeks (2-3/sex/group for cardiovascular safety, and 5/sex/group for toxicology)...
November 17, 2016: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/27862363/a-comprehensive-microbiological-safety-approach-for-agarose-encapsulated-porcine-islets-intended-for-clinical-trials
#19
Lawrence S Gazda, James Collins, Archie Lovatt, Robert W Holdcraft, Merribeth J Morin, Daniel Galbraith, Melanie Graham, Melissa A Laramore, Christine Maclean, John Black, Euan W Milne, Douglas G Marthaler, Horatiu V Vinerean, Michelle M Michalak, Deborah Hoffer, Steven Richter, Richard D Hall, Barry H Smith
BACKGROUND: The use of porcine islets to replace insulin-producing islet β-cells, destroyed during the diabetogenic disease process, presents distinct challenges if this option is to become a therapeutic reality for the treatment of type 1 diabetes. These challenges include a thorough evaluation of the microbiological safety of the islets. In this study, we describe a robust porcine islet-screening program that provides a high level of confidence in the microbiological safety of porcine islets suitable for clinical trials...
November 11, 2016: Xenotransplantation
https://www.readbyqxmd.com/read/27861630/correction-preclinical-development-of-ipilimumab-and-nivolumab-combination-immunotherapy-mouse-tumor-models-in-vitro-functional-studies-and-cynomolgus-macaque-toxicology
#20
Mark J Selby, John J Engelhardt, Robert J Johnston, Li-Sheng Lu, Minhua Han, Kent Thudium, Dapeng Yao, Michael Quigley, Jose Valle, Changyu Wang, Bing Chen, Pina M Cardarelli, Diann Blanset, Alan J Korman
[This corrects the article DOI: 10.1371/journal.pone.0161779.].
2016: PloS One
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