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https://www.readbyqxmd.com/read/28399519/pharmacokinetic-and-pharmacodynamic-modeling-of-mod-4023-a-long-acting-human-growth-hormone-in-growth-hormone-deficiency-children
#1
Dennis M Fisher, Ron G Rosenfeld, Michal Jaron-Mendelson, Leanne Amitzi, Ronit Koren, Gili Hart
BACKGROUND/AIMS: MOD-4023 is a long-acting human growth hormone (hGH) in clinical trials for the treatment of growth hormone deficiency (GHD). A key goal is maintenance of serum concentrations of insulin-like growth factor (IGF) 1 within normal range throughout GH dosing. The study aimed to develop a pharmacokinetic model for MOD-4023 and a pharmacodynamic model for the effect of MOD-4023 on IGF-1 to allow estimation of peak and mean IGF-1 and to identify the optimal IGF-1 sampling day...
April 11, 2017: Hormone Research in Pædiatrics
https://www.readbyqxmd.com/read/28323965/long-acting-ctp-modified-hgh-mod-4023-results-of-a-safety-and-dose-finding-study-in-ghd-children
#2
Nataliya Zelinska, Violeta Iotova, Julia Skorodok, Oleg Malievsky, Valentina Peterkova, Lubov Samsonova, Ron G Rosenfeld, Zvi Zadik, Michal Jaron-Mendelson, Ronit Koren, Leanne Amitzi, Dmitri Raduk, Oren Hershkovitz, Gili Hart
Context: Daily injections are required for growth hormone replacement therapy, which may cause low compliance as a result of inconvenience and distress in patients. Objective: CTP-modified human growth hormone (MOD-4023) is developed for once-a-week dosing regimen in GH-deficient (GHD) adults and children. The present trial was a safety and dose-finding study for weekly MOD-4023 in GHD children. Design: a multi-center, open-label, randomized, controlled Phase 2 study in children with GHD, evaluating the safety, tolerability, PK/PD and efficacy of 3 different weekly MOD-4023 doses, compared to daily r-hGH...
January 31, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28321676/transdermal-delivery-of-human-growth-hormone-via-laser-generated-micropores
#3
Yang Song, Karishma Hemmady, Ashana Puri, Ajay K Banga
The epidermal skin barrier plays an important role in protecting underlying structures. It allows the passage of low molecular weight lipophilic molecules, but restricts the passage of hydrophilic molecules and macromolecules. The objective of this study was to investigate the feasibility of transdermal delivery of human growth hormone (hGH) through laser-microporated dermatomed porcine ear skin. The permeation of hGH was evaluated at different laser fluences and micropore densities. In vitro permeation studies were performed on vertical Franz diffusion cells using dermatomed porcine ear skin treated with ablative laser (2940 nm; P...
March 20, 2017: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/28253515/growth-promotion-ethics-and-the-challenge-to-resist-cosmetic-endocrinology%C3%A2
#4
David B Allen
The advancement of "human growth hormone (hGH)-for-height" - increasing height attainment in children short for reasons other than GH deficiency - arose from intuitive, deep-seated assumptions about the disability of short stature, its improvement with hGH-mediated height gain, and the safety of escalating dosages of hGH in healthy children. Evidence challenging these assumptions now strengthens criticism of hGH-for-height as cosmetic endocrinology. To counter this characterization, collective acceptance of guidelines is needed that advise nontreatment of the vast majority of short children, support strategies that minimize treatment duration and dosage, and restrain enhancement of normal adult stature...
2017: Hormone Research in Pædiatrics
https://www.readbyqxmd.com/read/28099130/epidermal-growth-factor-receptor-egfr-involvement-in-successful-growth-hormone-gh-signaling-in-gh-transduction-defect
#5
Eirini Kostopoulou, Andrea Paola Rojas-Gil, Alexia Karvela, Bessie E Spiliotis
BACKGROUND: Growth hormone (GH) transduction defect (GHTD) is a growth disorder with impaired signal transducer and activator of transcription 3 (STAT3) phosphorylation mediated by overexpression of cytokine-inducible SH2-containing protein (CIS), which causes increased growth hormone receptor (GHR) degradation. This study investigated the role of epidermal growth factor (EGF) in the restoration of normal GH signaling in GHTD. METHODS: Protein expression, cellular localization and physical contact of proteins of the GH and EGF signaling pathways were studied by Western immunoblotting, immunofluorescence and co-immunoprecipitation, respectively...
February 1, 2017: Journal of Pediatric Endocrinology & Metabolism: JPEM
https://www.readbyqxmd.com/read/27923197/single-chain-fc-dimer-human-growth-hormone-fusion-protein-for-improved-drug-delivery
#6
Li Zhou, Hsuan-Yao Wang, Shanshan Tong, Curtis T Okamoto, Wei-Chiang Shen, Jennica L Zaro
Fc fusion protein technology has been successfully used to generate long-acting forms of several protein therapeutics. In this study, a novel Fc-based drug carrier, single chain Fc-dimer (sc(Fc)2), was designed to contain two Fc domains recombinantly linked via a flexible linker. Since the Fc dimeric structure is maintained through the flexible linker, the hinge region was omitted to further stabilize it against proteolysis and reduce FcγR-related effector functions. The resultant sc(Fc)2 candidate preserved the neonatal Fc receptor (FcRn) binding...
February 2017: Biomaterials
https://www.readbyqxmd.com/read/27920886/evaluation-of-recombinant-human-growth-hormone-secretion-in-e-coli-using-the-l-asparaginase-ii-signal-peptide
#7
Mozhdeh Zamani, Navid Nezafat, Younes Ghasemi
BACKGROUND: In the recent years, there has been an increasing interest in secretory production of recombinant proteins, due to its various advantages compared with intracellular expression. Signal peptides play a critical role in prosperous secretion of recombinant proteins. Accordingly, different signal peptides have been assessed for their ability to produce secretory proteins by trial-and-error experiments. The aim of this study was to evaluate the effect of L-asparaginase II signal peptide on the recombinant human Growth Hormone (hGH) protein secretion in the Escherichia coli (E...
October 2016: Avicenna Journal of Medical Biotechnology
https://www.readbyqxmd.com/read/27713394/effect-of-growth-hormone-and-igg-aggregates-on-dendritic-cells-activation-and-t-cells-polarization
#8
Yann Gallais, Natacha Szely, François-Xavier Legrand, Arnaud Leroy, Marc Pallardy, Isabelle Turbica
Patients treated with therapeutic biological products (BP) frequently develop anti-drug antibodies (ADA) with potential neutralizing capacities leading to loss of clinical response or serious side effects. BP aggregates have been suggested to promote immunogenicity, thus enhancing ADA production. Dendritic cells (DC) are key effectors in T-cell and B-cell fates, and the subsequent generation of immunogenicity. The objective of this work was to determine if BP aggregates can participate to DC maturation and T-cell activation...
March 2017: Immunology and Cell Biology
https://www.readbyqxmd.com/read/27670405/unexpected-effects-of-the-mip-creer-transgene-and-tamoxifen-on-%C3%AE-cell-growth-in-c57bl6-j-male-mice
#9
Bethany A Carboneau, Thao D V Le, Jennifer C Dunn, Maureen Gannon
Transgenic mouse models have been fundamental in the discovery of factors that regulate β-cell development, mass, and function. Several groups have recently shown that some of these models display previously uncharacterized phenotypes due to the transgenic system itself. These include impaired islet function and increased β-cell mass due to the presence of a human growth hormone (hGH) minigene as well as impaired β-cell proliferation in response to tamoxifen (TM) administration. We aimed to determine how these systems impact β-cell mass and proliferation during high fat diet (HFD)...
September 2016: Physiological Reports
https://www.readbyqxmd.com/read/27665368/preparation-of-soluble-isotopically-labeled-human-growth-hormone-produced-in-escherichia-coli
#10
Jin-Hee Lee, Ji-Seon Jeong, Sook-Kyung Kim, Jimyeong Song, Ji Youn Lee, Soyun Baek, Jun-Hyuk Choi
Isotopically labeled proteins have been used as internal standards for mass spectrometry (MS)-based absolute protein quantification. Although this approach can provide highly accurate analyses of proteins of interest within a complex mixture, one of the major limitations of this method is the difficulty in preparing uniformly labeled standards. Human growth hormone (hGH) is one of the most important hormones that circulate throughout the body, and its measurement is primarily of interest in the diagnosis and treatment of growth disorders...
November 1, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27659863/biophysical-evaluation-of-hybrid-fc-fusion-protein-of-hgh-to-achieve-basal-buffer-system
#11
Nam Ah Kim, In Bok An, Hye Seong Lim, Sang In Yang, Seong Hoon Jeong
A newly developed hybrid Fc (hyFc) is a non-immunogenic and non-cytolytic Fc with intact Ig structure derived from human IgD and IgG4. It is fused with the human growth hormone (GXD-9) and was evaluated by various biophysical techniques. Two thermal transitions were evident by DSC, reflecting the unfolding of IgG4 and the conjugated protein. The highest Tm of the initial GXD-9 was 68.17°C and the Tm of the two domains were around 66°C and 70°C. Although Tm increased with decreasing concentration, which reflects increasing conformational stability, aggregation issues were still observed by DLS...
November 20, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27507700/determination-of-recent-growth-hormone-abuse-using-a-single-dried-blood-spot
#12
Gemma Reverter-Branchat, Jaume Bosch, Jessica Vall, Magí Farré, Esther Papaseit, Simona Pichini, Jordi Segura
BACKGROUND: Although it is being increasingly applied, blood collection for drug testing in sport presents some logistic issues that complicate full applicability on a large scale. The use of dried blood spots (DBS) could benefit compliant blood testing considerably owing to its simplicity, minimal invasiveness, analyte stability, and reduced costs. The aim of this study was to evaluate the applicability of DBS to the methodology approved by the World Anti-Doping Agency (WADA) for detection of doping by recombinant human growth hormone (rhGH) in serum...
October 2016: Clinical Chemistry
https://www.readbyqxmd.com/read/27464380/cephalometric-analysis-of-adults-with-turner-syndrome
#13
Christina Svanberg, Lars-Inge Norevall, Bertil Ekman, Jeanette Wahlberg, Mats Bågesund
Turner syndrome (TS) is a genetic disorder of females with a prevalence of 1/2000-3000 live female births. The aim of this study was to compare cephalometric variables from adult women diagnosed with TS to a standardized reference group of 31-year old healthy women, and to evaluate the possible effects of human growth hormone (hGH) therapy in women with TS. Registered TS subjects in the Southeast region of Sweden were invited to take part in the study. Twenty-one women aged 36 ± 13(18-57) years accepted participation...
2016: Swedish Dental Journal
https://www.readbyqxmd.com/read/27454394/relationship-between-changes-in-workplace-bullying-status-and-the-reporting-of-personality-characteristics
#14
Roger Persson, Annie Høgh, Matias Brødsgaard Grynderup, Morten Vejs Willert, Maria Gullander, Åse Marie Hansen, Henrik Albert Kolstad, Ole Mors, Eva Gemzøe Mikkelsen, Ann Suhl Kristensen, Linda Kaerlev, Reiner Rugulies, Jens Peter Ellekilde Bonde
OBJECTIVE: To examine whether a shift in work-related bullying status, from being non-bullied to being bullied or vice versa, was associated with changes in reporting of personality characteristics. METHODS: Data on bullying and personality (neuroticism, extraversion, and sense of coherence) were collected in three waves approximately 2 years apart (N = 4947). Using a within-subjects design, personality change scores that followed altered bullying status were evaluated with one-sample t tests...
September 2016: Journal of Occupational and Environmental Medicine
https://www.readbyqxmd.com/read/27406716/adherence-in-children-with-growth-hormone-deficiency-treated-with-r-hgh-and-the-easypod%C3%A2-device
#15
S Loche, M Salerno, P Garofalo, G M Cardinale, M R Licenziati, G Citro, M Caruso Nicoletti, M Cappa, S Longobardi, M Maghnie, R Perrone
PURPOSE: Poor adherence to recombinant human growth hormone (r-hGH) therapy is associated with reduced growth velocity in children with growth hormone deficiency (GHD). This twelve-month observational study was to assess adherence in r-hGH patients treated with the easypod(™), an electronic, fully automated injection device designed to track the time, date and dose administered. METHODS: Ninety-seven prepubertal patients receiving r-hGH therapy were included in the study from ten Italian clinical sites and 88 completed the study...
December 2016: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/27323961/wnt4-mediates-the-autocrine-effects-of-growth-hormone-in-mammary-carcinoma-cells
#16
Cécile M Vouyovitch, Jo K Perry, Dong Xu Liu, Laurent Bezin, Eric Vilain, Jean-Jacques Diaz, Peter E Lobie, Hichem C Mertani
The expression of Wingless and Int-related protein (Wnt) ligands is aberrantly high in human breast cancer. We report here that WNT4 is significantly upregulated at the mRNA and protein level in mammary carcinoma cells expressing autocrine human growth hormone (hGH). Depletion of WNT4 using small interfering (si) RNA markedly decreased the rate of human breast cancer cell proliferation induced by autocrine hGH. Forced expression of WNT4 in the nonmalignant human mammary epithelial cell line MCF-12A stimulated cell proliferation in low and normal serum conditions, enhanced cell survival and promoted anchorage-independent growth and colony formation in soft agar...
July 2016: Endocrine-related Cancer
https://www.readbyqxmd.com/read/27243825/genetic-and-protein-biomarkers-in-blood-for-the-improved-detection-of-gh-abuse
#17
P Ferro, R Ventura, C Pérez-Mañá, M Farré, J Segura
Human Growth Hormone (hGH, somatotropin) is one of the relevant forbidden substances to be detected in sport drug testing. Since the appearance of recombinant hGH (rhGH) in the 80's, its expansion and availability through the black market have increased, so the detection of its abuse continues to be a challenge at present. New techniques or biomarkers that are robust, reliable, sensitive and allowing a large detection time window are welcome. rhGH produces an increase of insulin-like growth factor 1 (IGF-1)...
September 5, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/27242314/in-vivo-residence-duration-of-human-growth-hormone-loaded-in-nanogels-comprising-cinnamoyl-alginate-cinnamoyl-pluronic-f127-and-cinnamoyl-poly-ethylene-glycol
#18
Dong Youl Yoon, Jin-Chul Kim
Cinnamoyl alginate, cinnamoyl Pluronic F127 and cinnamoyl poly(ethylene glycol) were self-assembled into nanogel in aqueous phase. The size of nanogel was 100nm-200nm on TEM photos. When 1ml of human growth hormone (hGH) solution (5mg/ml, pH3.0) was mixed with 4ml of the nanogel suspension (37.5mg/ml, pH3.0), 100% of hGH was loaded in the nanogels (corresponding to specific loading of 3.33% (w hGH/w nanogel)). In the in vivo pharmacokinetics study, the substantial blood level of hGH was maintained during the entire experiment period (two weeks) after one-time injection of hGH-loaded nanogel at 0...
July 25, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27184708/blood-biomarkers-of-endocrine-immune-inflammatory-and-metabolic-systems-in-obstructive-sleep-apnea
#19
MULTICENTER STUDY
Wesley Elon Fleming, Aliya Ferouz-Colborn, Michael K Samoszuk, Armaghan Azad, Jiuliu Lu, John S Riley, Amabelle B Cruz, Susann Podolak, Doni J Clark, Kurtis R Bray, Paula C Southwick
OBJECTIVE/BACKGROUND: Obstructive sleep apnea (OSA) is a common disorder, affecting over 100 million adults. Untreated OSA leads to serious health consequences and perturbations in endocrine, immune, inflammatory, and metabolic systems. Study objectives are to evaluate the association between OSA and biomarkers, and to test the hypothesis that a combination of markers may be useful in screening for OSA. PATIENTS/METHODS: A multicenter trial was conducted enrolling symptomatic male patients with suspected OSA...
August 2016: Clinical Biochemistry
https://www.readbyqxmd.com/read/27158200/growth-hormone-abolishes-the-negative-effects-of-everolimus-on-intestinal-wound-healing
#20
Markus Alexander Küper, Sebastian Trütschel, Jürgen Weinreich, Alfred Königsrainer, Stefan Beckert
AIM: To investigate whether the simultaneous treatment with human growth hormone (hGH) abolishes the negative effects of everolimus on anastomotic healing. METHODS: Forty-eight male Sprague-Dawley-rats were randomized to three groups of 16 animals each (I: vehicle; II: everolimus 3 mg/kg po; III: everolimus 3 mg/kg po + hGH 2.5 mg/kg sc). Animals were pre-treated with hGH and/or everolimus daily for seven days. Then a standard anastomosis was created in the descending colon and treatment was continued for another seven days...
May 7, 2016: World Journal of Gastroenterology: WJG
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