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https://www.readbyqxmd.com/read/28444973/in-depth-comparative-phenotyping-of-blood-innate-myeloid-leukocytes-from-healthy-humans-and-macaques-using-mass-cytometry
#1
Jamila Elhmouzi-Younes, Jean-Louis Palgen, Nicolas Tchitchek, Simon Delandre, Inana Namet, Caroline L Bodinham, Kathleen Pizzoferro, David J M Lewis, Roger Le Grand, Antonio Cosma, Anne-Sophie Beignon
Comparative immune-profiling of innate responses in humans and non-human primates is important to understand the pathogenesis of infectious and chronic inflammatory diseases as well as for the preclinical development of vaccines and immune therapies. However, direct comparisons of the two species are rare and were never performed using mass cytometry. Here, whole-blood-derived leukocytes from healthy humans and cynomolgus macaques were analyzed with mass cytometry. Two similar panels of around 30 monoclonal antibodies targeting human markers associated with innate myeloid cells to stain fixed human and macaque leukocytes were constructed...
April 26, 2017: Cytometry. Part A: the Journal of the International Society for Analytical Cytology
https://www.readbyqxmd.com/read/28443538/iohexol-clearance-for-determination-of-glomerular-filtration-rate-in-cynomolgus-monkeys-macaca-fascicularis
#2
Changqing Zhang, Shanshan Ding, Yupeng Fang, Li Zhang, Weimin Hu, Jinlian Lu, Tao Jing, Yi Tao, Xin Zhang
The purpose of this study was to validate a method for determine the glomerular filtration rate (GFR) in healthy cynomolgus monkeys by using iohexol. Eighteen healthy cynomolgus macaque monkeys (age, 4 to 6 y [mean, 5 y]; weight, 2 to 6 kg [mean, 4 kg]) were randomly entered into 3 different doses groups (3 male and 3 female macaques per group) of 30, 60, 90 mg I/kg to receive an intravenous bolus injection of iohexol. Serum iohexol concentrations were determined by using liquid chromatography-tandem mass spectrometry, and clearance rate were determined by using WinNonlin software...
April 25, 2017: Journal of the American Association for Laboratory Animal Science: JAALAS
https://www.readbyqxmd.com/read/28439968/effects-of-an-ep2-and-ep3-receptor-dual-agonist-ono-8055-on-a-radical-hysterectomy-induced-underactive-bladder-model-in-monkeys
#3
Hidekazu Matsuya, Noritoshi Sekido, Jun Kida, Hiroko Mashimo, Daisuke Wakamatsu, Hiroki Okada
OBJECTIVES: The objective was to develop an underactive bladder (UAB) model in primates and to evaluate the potential of prostanoid EP2 and EP3 receptor dual agonist ONO-8055 to become a therapeutic agent for UAB. METHODS: A surgical procedure resembling radical hysterectomy was performed on female cynomolgus monkeys. Subsequently, in vitro muscle strip studies were performed using bladder muscle strips from normal monkeys and monkeys that underwent surgery. In addition, uroflowmetric data were obtained at specified days after the surgery...
April 25, 2017: Lower Urinary Tract Symptoms
https://www.readbyqxmd.com/read/28439900/herpes-b-virus-replication-and-viral-lesions-in-the-liver-of-a-cynomolgus-macaque-which-died-from-severe-disease-with-rapid-onset
#4
Stefan Pöhlmann, Michael Suntz, Valerij Akimkin, Martina Bleyer, Artur Kaul
Herpes B virus (BV, Macacine alphaherpesvirus 1) infects macaques asymptomatically, with rare exceptions, but can cause fatal encephalitis in humans. Here, we report disseminated BV infection in a cynomolgus macaque that had died within 12 hour after the onset of unspecific symptoms. Multifocal lesions surrounded by viral antigen were detected in liver while other organs remained inconspicuous, indicating that the liver is a major target. Moreover, high copy numbers of viral DNA were found in feces, underlining the excrements are a potential source of transmission...
April 25, 2017: Journal of Medical Primatology
https://www.readbyqxmd.com/read/28439081/long-lasting-neutralization-of-c5-by-sky59-a-novel-recycling-antibody-is-a-potential-therapy-for-complement-mediated-diseases
#5
Taku Fukuzawa, Zenjiro Sampei, Kenta Haraya, Yoshinao Ruike, Meiri Shida-Kawazoe, Yuichiro Shimizu, Siok Wan Gan, Machiko Irie, Yoshinori Tsuboi, Hitoshi Tai, Tetsushi Sakiyama, Akihisa Sakamoto, Shinya Ishii, Atsuhiko Maeda, Yuki Iwayanagi, Norihito Shibahara, Mitsuko Shibuya, Genki Nakamura, Takeru Nambu, Akira Hayasaka, Futa Mimoto, Yuu Okura, Yuji Hori, Kiyoshi Habu, Manabu Wada, Takaaki Miura, Tatsuhiko Tachibana, Kiyofumi Honda, Hiroyuki Tsunoda, Takehisa Kitazawa, Yoshiki Kawabe, Tomoyuki Igawa, Kunihiro Hattori, Junichi Nezu
Dysregulation of the complement system is linked to the pathogenesis of a variety of hematological disorders. Eculizumab, an anti-complement C5 monoclonal antibody, is the current standard of care for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). However, because of high levels of C5 in plasma, eculizumab has to be administered biweekly by intravenous infusion. By applying recycling technology through pH-dependent binding to C5, we generated a novel humanized antibody against C5, SKY59, which has long-lasting neutralization of C5...
April 24, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28436281/terfenadine-t-butyl-hydroxylation-catalyzed-by-human-and-marmoset-cytochrome-p450-3a-and-4f-enzymes-in-livers-and-small-intestines
#6
Shotaro Uehara, Yukako Yuki, Yasuhiro Uno, Takashi Inoue, Erika Sasaki, Hiroshi Yamazaki
1. Roles of human cytochrome P450 (P450) 3A4 in oxidation of an antihistaminic drug terfenadine have been previously investigated in association with terfenadine-ketoconazole interaction. Several antihistamine drugs have been recently identified as substrates for multiple P450 enzymes. In this study, overall roles of P450 3A4, 2J2, and 4F12 enzymes in terfenadine t-butyl hydroxylation were investigated in small intestines and livers from humans, marmosets, and/or cynomolgus monkeys. 2. Human liver microsomes and liver and small intestine microsomes from marmosets and cynomolgus monkeys effectively mediated terfenadine t-butyl hydroxylation...
April 22, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28433587/pharmacokinetic-and-toxicology-comparator-testing-of-biosimilar-drugs-assessing-need
#7
Paul Baldrick
A key element in the development of a biosimilar molecule is the comparability of the biological activity/nonclinical similarity to the innovator drug. Although some regulatory guidelines are encouraging little or no in vivo testing, currently a common practice is to perform at least one toxicology and/or one pharmacokinetic (PK) study to assess if any different findings occur for in-life, clinical pathology and histopathological parameters or in exposure. An exercise was performed in which the results of such testing were evaluated...
April 20, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28431929/effects-of-naturally-occurring-charged-mutations-on-the-structure-stability-and-binding-of-the-pin1-ww-domain
#8
Xiaoya Qiao, Ying Liu, Liting Luo, Lei Chen, Caixian Zhao, Xuanjun Ai
Pin1 is a peptidyl-prolyl cis-trans isomerase, whose WW domain specifically recognizes the pSer/Thr-Pro motif. Pin1 is involved in multiple phosphorylation events that regulate the activities of various substrates, and Pin1 deregulation has been reported in various diseases, including cancer and Alzheimer's disease. The WW domain of Pin1 has been used as a small model protein to investigate the folding mechanisms of the β-sheet structure by studying the effect of mutations or its naturally occurring variants...
April 19, 2017: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/28429751/preclinical-study-of-raav2-strail-pharmaceutical-efficacy-biodistribution-and-safety-in-animals
#9
Q Ru, W Li, X Wang, S Zhang, L Chen, Y Zhang, Y Ge, Y Zu, Y Liu, D Zheng
The recombinant sTRAIL has been in clinical trial for various human malignancies. However, the half-life time of sTRAIL is very short, which might be an important factor influencing its clinical efficacy for cancer therapy. We previously reported the recombinant adeno-associated virus (AAV)-encoding sTRAIL95-281-mediated sTRAIL expression in vivo up to 8 months and suppressed tumor growth markedly in mouse xenografts. In the present study, we further evaluated the clinical potency for cancer gene therapy and the safety in mouse and non-human primates...
April 21, 2017: Cancer Gene Therapy
https://www.readbyqxmd.com/read/28428078/kinetic-reconstruction-reveals-time-dependent-effects-of-romosozumab-on-bone-formation-and-osteoblast-function-in-vertebral-cancellous-and-cortical-bone-in-cynomolgus-monkeys
#10
Rogely Waite Boyce, Qing-Tian Niu, Michael S Ominsky
Romosozumab, a humanized monoclonal sclerostin antibody under development for the treatment of osteoporosis, has a unique mechanism of action on bone-increasing bone formation and decreasing bone resorption. The effects on bone formation are transient, eliciting a rapid increase in bone formation that attenuates with continued treatment. Although bone formation attenuates, bone mineral density (BMD) continues to increase. To explore potential tissue-level mechanisms that could contribute to a progressive increase in spine BMD, we used kinetic reconstruction techniques to examine the effects of romosozumab on modeling and remodeling units in vertebral cancellous bone from adult cynomolgus monkeys administered romosozumab for 10 and 28weeks...
April 18, 2017: Bone
https://www.readbyqxmd.com/read/28421387/pharmacokinetics-of-monoclonal-antibodies-and-fc-fusion-proteins
#11
REVIEW
Liming Liu
There are many factors that can influence the pharmacokinetics (PK) of a mAb or Fc-fusion molecule with the primary determinant being FcRn-mediated recycling. Through Fab or Fc engineering, IgG-FcRn interaction can be used to generate a variety of therapeutic antibodies with significantly enhanced half-life or ability to remove unwanted antigen from circulation. Glycosylation of a mAb or Fc-fusion protein can have a significant impact on the PK of these molecules. mAb charge can be important and variants with pI values of 1-2 unit difference are likely to impact PK with lower pI values being favorable for a longer half-life...
April 19, 2017: Protein & Cell
https://www.readbyqxmd.com/read/28416413/evaluation-of-the-physiotel%C3%A2-digital-m11-cardiovascular-telemetry-implant-in-socially-housed-cynomolgus-monkeys-up-to-16weeks-after-surgery
#12
Ninette K Andersen, Olivier Meyer, Alys Bradley, Nils Dragsted, Anders B Lassen, Ingrid Sjögren, Julie M Larsen, Warren Harvey, Rastislav Bator, Aileen Milne
INTRODUCTION: The novel PhysioTel™ Digital M11 telemetry implant was evaluated in socially housed monkeys with respect to both safety pharmacological cardiovascular (arterial blood pressure (BP), heart rate (HR) and electrocardiogram (ECG)) and toxicological (clinical pathology and histopathology) endpoints. METHODS: Telemetry and clinical pathology data were obtained repeatedly up to 16weeks after surgery in four female cynomolgus monkeys, followed by necropsy...
April 14, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28402755/distribution-of-fcrn-across-species-and-tissues
#13
Sari Latvala, Bjoern Jacobsen, Michael B Otteneder, Annika Herrmann, Sven Kronenberg
The neonatal Fc receptor (FcRn) is a major histocompatibility complex class I type molecule that binds to, transports, and recycles immunoglobulin G (IgG) and albumin, thereby protecting them from lysosomal degradation. Therefore, besides the knowledge of FcRn affinity, FcRn protein expression is critical in understanding the pharmacokinetic behavior of Fc-containing biotherapeutics such as monoclonal antibodies. The goal of this investigation was to achieve for the first time a comparative assessment of FcRn distribution across a variety of tissues and species...
April 1, 2017: Journal of Histochemistry and Cytochemistry: Official Journal of the Histochemistry Society
https://www.readbyqxmd.com/read/28396527/leveraging-of-rifampicin-dosed-cynomolgus-monkeys-to-identify-bile-acid-3-o-sulfate-conjugates-as-potential-novel-biomarkers-for-organic-anion-transporting-polypeptides
#14
Rhishikesh Thakare, Hongying Gao, Rachel E Kosa, Yi-An Bi, Manthena V S Varma, Matthew Cerny, Raman Sharma, Max Kuhn, Bingshou Huang, Yiping Liu, Aijia Yu, Gregory S Walker, Mark Niosi, Larry M Tremaine, Yazen Alnouti, A David Rodrigues
In the search for novel bile acid (BA) biomarkers of liver organic anion-transporting polypeptides (OATPs), cynomolgus monkeys received oral rifampicin (RIF) at four dose levels (1, 3, 10 and 30 mg/kg) that generated plasma free Cmax values (0.06, 0.66, 2.57 and 7.79 μM, respectively) that covered the reported in vitro IC50s for OATP1B1 and OATP1B3 (≤ 1.7 μM). As expected, the area under the plasma concentration-time curve (AUC) of an OATP probe drug (intravenous (2)H4-pitavastatin, 0.2 mg/kg) was increased 1...
April 10, 2017: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/28387635/identification-of-human-igg1-variant-with-enhanced-fcrn-binding-and-without-increased-binding-to-rheumatoid-factor-autoantibody
#15
Atsuhiko Maeda, Yuki Iwayanagi, Kenta Haraya, Tatsuhiko Tachibana, Genki Nakamura, Takeru Nambu, Keiko Esaki, Kunihiro Hattori, Tomoyuki Igawa
Various studies have demonstrated that Fc engineering to enhance neonatal Fc receptor (FcRn) binding is effective for elongating half-life or increasing cellular uptake of IgG. A previous study has shown that a N434H mutation to enhance FcRn binding resulted in increased binding to rheumatoid factor (RF) autoantibody, which is not desirable for therapeutic use in autoimmune disease. In this study, we first showed that all the existing Fc variants with enhanced FcRn binding also show increased RF binding, and then identified specific mutations that could be introduced to those Fc variants to reduce the RF binding...
April 7, 2017: MAbs
https://www.readbyqxmd.com/read/28381665/establishment-of-reference-values-for-complete-blood-count-and-blood-gases-in-cynomolgus-monkeys-macaca-fascicularis
#16
Shunya Nakayama, Hiroshi Koie, Kiichi Kanayama, Yuko Katakai, Yasuyo Ito-Fujishiro, Tadashi Sankai, Yasuhiro Yasutomi, Naohide Ageyama
Cynomolgus monkeys are closely related to humans phylogenetically, and this has resulted in their widespread use as a preclinical model. Hematological data with regard to these monkeys are thus important. Although reference values for blood components and sex hormones have been established for cynomolgus monkeys, those for arterial blood gases have not. The arterial blood gases quickly reflect respiratory and circulatory dynamics, and are thus useful for animal management and safe general anesthesia and surgical operations...
April 1, 2017: Journal of Veterinary Medical Science
https://www.readbyqxmd.com/read/28365864/long-term-blood-glucose-monitoring-with-implanted-telemetry-device-in-conscious-and-stress-free-cynomolgus-monkeys
#17
B Wang, G Sun, W Qiao, Y Liu, J Qiao, W Ye, H Wang, X Wang, R Lindquist, Y Wang, Y-F Xiao
AIMS: Continuous blood glucose monitoring, especially long-term and remote, in diabetic patients or research is very challenging. Nonhuman primate (NHP) is an excellent model for metabolic research, because NHPs can naturally develop Type 2 diabetes mellitus (T2DM) similarly to humans. This study was to investigate blood glucose changes in conscious, moving-free cynomolgus monkeys (Macaca fascicularis) during circadian, meal, stress and drug exposure. MATERIALS AND METHODS: Blood glucose, body temperature and physical activities were continuously and simultaneously recorded by implanted HD-XG telemetry device for up to 10 weeks...
April 1, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28363269/establishing-a-large-animal-model-for-in-vivo-reprogramming-of-bile-duct-cells-into-insulin-secreting-cells-to-treat-diabetes
#18
Caitlin Marie Hill, Anannya Banga, Juan E Abrahante, Ce Yuan, Lucas A Mutch, Jody Janecek, Timothy O'Brien, Melanie L Graham, James Dutton
Type I diabetes manifests in autoimmune destruction of beta cells requiring metabolic management with an exogenous replacement source of insulin, either by repeated injection of recombinant insulin or by transplantation of allogenic islets from cadaveric donors. Both of these approaches have severe limitations. Repeated insulin injection requires intensive blood glucose monitoring, is expensive, and is associated with decreased quality of life measures. Islet transplant, while highly effective, is severely limited by shortage of donor organs...
March 31, 2017: Human Gene Therapy. Clinical Development
https://www.readbyqxmd.com/read/28356537/pathogenic-events-in-a-nonhuman-primate-model-of-oral-poliovirus-infection-leading-to-paralytic-poliomyelitis
#19
Ling Shen, Crystal Y Chen, Dan Huang, Richard Wang, Meihong Zhang, Lixia Qian, Yanfen Zhu, Alvin Zhuoran Zhang, Enzhuo Yang, Arwa Qaqish, Konstantin Chumakov, Diana Kouiavskaia, Marco Vignuzzi, Neal Nathanson, Andrew J Macadam, Raul Andino, Olen Kew, Junfa Xu, Zheng W Chen
Despite a great deal of prior research, the early pathogenic events in natural oral poliovirus infection remain poorly defined. To establish a model for study, we infected 39 macaques by feeding single high doses of the virulent Mahoney strain of wild type 1 poliovirus. Doses ranging from10(7)-10(9) TCID50 consistently infected all animals, and most monkeys receiving 10(8) or 10(9) TCID50 developed paralysis. There was no apparent difference in the susceptibility of the three macaque species (rhesus, cynomolgus, and bonnet) used...
March 29, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28349944/discrimination-of-stem-cell-status-after-subjecting-cynomolgus-monkey-pluripotent-stem-cells-to-na%C3%A3-ve-conversion
#20
Arata Honda, Yoshihiro Kawano, Haruna Izu, Narantsog Choijookhuu, Kimiko Honsho, Tomonori Nakamura, Yukihiro Yabuta, Takuya Yamamoto, Yasuhiro Takashima, Michiko Hirose, Tadashi Sankai, Yoshitaka Hishikawa, Atsuo Ogura, Mitinori Saitou
Experimental animal models have played an indispensable role in the development of human induced pluripotent stem cell (iPSC) research. The derivation of high-quality (so-called "true naïve state") iPSCs of non-human primates enhances their application and safety for human regenerative medicine. Although several attempts have been made to convert human and non-human primate PSCs into a truly naïve state, it is unclear which evaluation methods can discriminate them as being truly naïve. Here we attempted to derive naïve cynomolgus monkey (Cm) (Macaca fascicularis) embryonic stem cells (ESCs) and iPSCs...
March 28, 2017: Scientific Reports
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