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2015 monoclonal antibodies

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https://www.readbyqxmd.com/read/29136037/safety-pharmacokinetics-and-immunological-activities-of-multiple-intravenous-or-subcutaneous-doses-of-an-anti-hiv-monoclonal-antibody-vrc01-administered-to-hiv-uninfected-adults-results-of-a-phase-1-randomized-trial
#1
Kenneth H Mayer, Kelly E Seaton, Yunda Huang, Nicole Grunenberg, Abby Isaacs, Mary Allen, Julie E Ledgerwood, Ian Frank, Magdalena E Sobieszczyk, Lindsey R Baden, Benigno Rodriguez, Hong Van Tieu, Georgia D Tomaras, Aaron Deal, Derrick Goodman, Robert T Bailer, Guido Ferrari, Ryan Jensen, John Hural, Barney S Graham, John R Mascola, Lawrence Corey, David C Montefiori
BACKGROUND: VRC01 is an HIV-1 CD4 binding site broadly neutralizing antibody (bnAb) that is active against a broad range of HIV-1 primary isolates in vitro and protects against simian-human immunodeficiency virus (SHIV) when delivered parenterally to nonhuman primates. It has been shown to be safe and well tolerated after short-term administration in humans; however, its clinical and functional activity after longer-term administration has not been previously assessed. METHODS AND FINDINGS: HIV Vaccine Trials Network (HVTN) 104 was designed to evaluate the safety and tolerability of multiple doses of VRC01 administered either subcutaneously or by intravenous (IV) infusion and to assess the pharmacokinetics and in vitro immunologic activity of the different dosing regimens...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29113531/detection-of-cytomegalovirus-herpes-virus-simplex-and-parvovirus-b19-in-spontaneous-abortion-placentas
#2
Gabriela Mafra de Oliveira, Marcelo Antônio Pascoal-Xavier, Daniel R Moreira, Vitor Souza Guimarães, Regina Amélia Lopes Pessoa de Aguiar, Débora Marques de Miranda, Roberta Maia de Castro Romanelli
OBJECTIVE: This study aims to investigate the presence of Cytomegalovirus (CMV), herpes virus simplex (HSV), and parvovirus B19 (PVB19) in the placental tissue of patients who underwent abortions without an otherwise-defined aetiology. STUDY DESIGN: This cross-sectional study was conducted in a high-risk obstetric maternity facility at a University Hospital in Belo Horizonte, Brazil, from January 2013 to December 2015. We included placenta samples obtained from spontaneous abortions of unknown aetiology...
November 7, 2017: Journal of Maternal-fetal & Neonatal Medicine
https://www.readbyqxmd.com/read/29076496/androgen-receptor-splice-variant-7-positive-prostate-cancer-a-novel-molecular-subtype-with-markedly-worse-androgen-deprivation-therapy-outcomes-in-newly-diagnosed-patients
#3
Heng Li, Zhize Wang, Wei Xiao, Libin Yan, Wei Guan, Zhiquan Hu, Lily Wu, Qihong Huang, Ji Wang, Hua Xu, Xu Zhang, Zhangqun Ye
Androgen-deprivation therapy has been the standard treatment for metastatic and locally advanced prostate cancer, but the majority of patients will progress to castration-resistant prostate cancer within 2-3 years. Unlike the case in breast cancer, no clinically validated biomarker has been used to predict the outcomes of androgen-deprivation therapy. To evaluate androgen-receptor splice variant-7 (AR-V7) detection in newly diagnosed advanced prostate cancer and describe the distinctive prognosis of this novel molecular subtype, this study retrospectively enrolled 168 newly diagnosed prostate cancer patients from 2003 to 2015 who received androgen-deprivation therapy...
October 27, 2017: Modern Pathology: An Official Journal of the United States and Canadian Academy of Pathology, Inc
https://www.readbyqxmd.com/read/29061772/monoclonal-antibodies-for-the-treatment-of-cancer
#4
REVIEW
Joseph Thomas Pento
The ability of cancer cells to evade the immune system is one of the most deadly characteristics of the majority of malignant tumours. Accordingly, the recent development of antibodies which target tumor cell evasion of immune checkpoints such as the cytotoxic T lymphocyte associated antigen-4 (CTLA-4) as well as the programmed cell death protein (PD-1) and the PD-1 ligand (PD-L1) has been a major and apparently highly effective approach in the treatment and/or eradication of a variety of highly malignant forms of cancers...
November 2017: Anticancer Research
https://www.readbyqxmd.com/read/29052598/association-between-clinicopathological-characteristics-and-ras-mutation-in-colorectal-cancer
#5
Johan Rimbert, Gaëlle Tachon, Audelaure Junca, Claire Villalva, Lucie Karayan-Tapon, David Tougeron
In colorectal cancer, KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations are associated with resistance to antiepidermal growth factor receptor monoclonal antibodies, and BRAF mutation is a molecular marker of poor prognosis. KRAS exon 2 and BRAF-mutated colorectal cancers have well-known distinct clinicopathological characteristics. Comparison of tumors with different RAS status (exons 2, 3, and 4 of KRAS and NRAS) based on their clinicopathological characteristics has never been established. All colorectal cancer patients with RAS and BRAF testing from 2011 to 2015 were included in this observational retrospective study...
October 20, 2017: Modern Pathology: An Official Journal of the United States and Canadian Academy of Pathology, Inc
https://www.readbyqxmd.com/read/29037983/safety-pharmacokinetics-and-antitumour-activity-of-trastuzumab-deruxtecan-ds-8201-a-her2-targeting-antibody-drug-conjugate-in-patients-with-advanced-breast-and-gastric-or-gastro-oesophageal-tumours-a-phase-1-dose-escalation-study
#6
Toshihiko Doi, Kohei Shitara, Yoichi Naito, Akihiko Shimomura, Yasuhiro Fujiwara, Kan Yonemori, Chikako Shimizu, Tatsunori Shimoi, Yasutoshi Kuboki, Nobuaki Matsubara, Atsuko Kitano, Takahiro Jikoh, Caleb Lee, Yoshihiko Fujisaki, Yusuke Ogitani, Antoine Yver, Kenji Tamura
BACKGROUND: Antibody-drug conjugates have emerged as a powerful strategy in cancer therapy and combine the ability of monoclonal antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. Trastuzumab deruxtecan (also known as DS-8201) is an antibody-drug conjugate comprised of a humanised antibody against HER2, a novel enzyme-cleavable linker, and a topoisomerase I inhibitor payload. We assessed its safety and tolerability in patients with advanced breast and gastric or gastro-oesophageal tumours...
October 13, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28970009/comparison-of-different-immunoassay-methods-to-detect-human-anti-drug-antibody-using-the-who-erythropoietin-antibody-reference-panel-for-analytes
#7
Hiroko Shibata, Kazuko Nishimura, Chizuru Miyama, Minoru Tada, Takuo Suzuki, Yoshiro Saito, Akiko Ishii-Watabe
Development of an appropriate assay to detect anti-drug antibody (ADA) is important for assessing immunogenicity to therapeutic protein products. However, characterizing ADA assay methods is difficult because human ADA as a reference standard is not available in most cases. We compared the analytical performance of three ligand-binding assay methods for ADA, namely, surface plasmon resonance (SPR), electrochemiluminescence (ECL), and biolayer interferometry (BLI) methods, by using the anti-erythropoietin (EPO) monoclonal antibody reference panel developed by the World Health Organization (WHO) in 2015...
September 29, 2017: Journal of Immunological Methods
https://www.readbyqxmd.com/read/28938590/ocular-toxicities-associated-with-targeted-anticancer-agents-an-analysis-of-clinical-data-with-management-suggestions
#8
Chen Fu, Dan S Gombos, Jared Lee, Goldy C George, Kenneth Hess, Andrew Whyte, David S Hong
Ocular toxicities are among the most common adverse events resulting from targeted anticancer agents and are becoming increasingly relevant in the management of patients on these agents. The purpose of this study is to provide a framework for management of these challenging toxicities based on objective data from FDA labels and from analysis of the literature. All oncologic drugs approved by the FDA up to March 14, 2015, were screened for inclusion. A total of 16 drugs (12 small-molecule drugs and 4 monoclonal antibodies) were analyzed for ocular toxicity profiles based on evidence of ocular toxicity...
August 29, 2017: Oncotarget
https://www.readbyqxmd.com/read/28935894/strain-dependent-neutralization-reveals-antigenic-variation-of-human-parechovirus-3
#9
Eveliina Karelehto, Sabine van der Sanden, James A Geraets, Aušra Domanska, Lonneke van der Linden, Dionne Hoogendoorn, Gerrit Koen, Hetty van Eijk, Shabih Shakeel, Tim Beaumont, Menno de Jong, Dasja Pajkrt, Sarah J Butcher, Katja C Wolthers
Human parechovirus 3 (HPeV3), a member of the Picornavirus family, is frequently detected worldwide. However, the observed seropositivity rates for HPeV3 neutralizing antibodies (nAbs) vary from high in Japan to low in the Netherlands and Finland. To study if this can be explained by technical differences or antigenic diversity among HPeV3 strains included in the serological studies, we determined the neutralizing activity of Japanese and Dutch intravenous immunoglobulin batches (IVIG), a rabbit HPeV3 hyperimmune polyclonal serum, and a human HPeV3-specific monoclonal antibody (mAb) AT12-015, against the HPeV3 A308/99 prototype strain and clinical isolates from Japan, the Netherlands and Australia, collected between 1989 and 2015...
September 21, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28933516/anti-il5-therapies-for-asthma
#10
REVIEW
Hugo A Farne, Amanda Wilson, Colin Powell, Lynne Bax, Stephen J Milan
BACKGROUND: This review is the first update of a previously published review in The Cochrane Library (Issue 7, 2015). Interleukin-5 (IL-5) is the main cytokine involved in the activation of eosinophils, which cause airway inflammation and are a classic feature of asthma. Monoclonal antibodies targeting IL-5 or its receptor (IL-5R) have been developed, with recent studies suggesting that they reduce asthma exacerbations, improve health-related quality of life (HRQoL) and lung function...
September 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28904172/fda-approval-summary-daratumumab-for-treatment-of-multiple-myeloma-after-one-prior-therapy
#11
Vishal Bhatnagar, Nicole J Gormley, Lola Luo, Yuan Li Shen, Rajeshwari Sridhara, Sriram Subramaniam, Guoxiang Shen, Lian Ma, Stacy Shord, Kirsten B Goldberg, Ann T Farrell, Amy E McKee, Richard Pazdur
On November 21, 2016, the U.S. Food and Drug Administration granted regular approval to daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on two randomized, open-label trials in which daratumumab was added to these backbone therapies. The MMY3003 trial demonstrated substantial improvement in progression-free survival (PFS) when daratumumab was added to lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone...
September 13, 2017: Oncologist
https://www.readbyqxmd.com/read/28902269/development-of-in-house-serological-methods-for-diagnosis-and-surveillance-of-chikungunya
#12
Saira Saborío Galo, Karla González, Yolanda Téllez, Nadezna García, Leonel Pérez, Lionel Gresh, Eva Harris, Ángel Balmaseda
Objective: To develop and evaluate serological methods for chikungunya diagnosis and research in Nicaragua. Methods: Two IgM ELISA capture systems (MAC-ELISA) for diagnosis of acute chikungunya virus (CHIKV) infections, and two Inhibition ELISA Methods (IEM) to measure total antibodies against CHIKV were developed using monoclonal antibodies (mAbs) and hyperimmune serum at the National Virology Laboratory of Nicaragua in 2014-2015. The sensitivity, specificity, predictive values, and agreement of the MAC-ELISAs were obtained by comparing the results of 198 samples (116 positive; 82 negative) with the Centers for Disease Control and Prevention's IgM ELISA (Atlanta, Georgia, United States; CDC-MAC-ELISA)...
August 21, 2017: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/28883282/development-of-immune-checkpoint-inhibitors
#13
Shigehisa Kitano
Immune checkpoint inhibitors are the most striking innovation in the clinical development of immunotherapy. Monoclonal antibodies (mAbs) restore and augment the antitumor immune activities of cytotoxic T cells by mainly blocking immune checkpoint molecules on T cells or their ligands on antigen-presenting and tumor cells. Based on preclinical data, many clinical trials have demonstrated the acceptable safety profiles and efficacies of mAb in various cancers. The A first-in-class approved immune checkpoint inhibitor is ipilimumab, which is a fully humanized mAb that blocks the immunosuppressive signal by cytotoxic T-lymphocyte antigen 4...
2017: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/28859947/clinical-efficacy-and-safety-of-achieving-very-low-ldl-cholesterol-concentrations-with-the-pcsk9-inhibitor-evolocumab-a-prespecified-secondary-analysis-of-the-fourier-trial
#14
Robert P Giugliano, Terje R Pedersen, Jeong-Gun Park, Gaetano M De Ferrari, Zbigniew A Gaciong, Richard Ceska, Kalman Toth, Ioanna Gouni-Berthold, Jose Lopez-Miranda, François Schiele, François Mach, Brian R Ott, Estella Kanevsky, Armando Lira Pineda, Ransi Somaratne, Scott M Wasserman, Anthony C Keech, Peter S Sever, Marc S Sabatine
BACKGROUND: LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). METHODS: In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up...
October 28, 2017: Lancet
https://www.readbyqxmd.com/read/28854896/acute-rhabdomyolysis-and-delayed-pericardial-effusion-in-an-italian-patient-with-ebola-virus-disease-a-case-report
#15
Emanuele Nicastri, Antonio Brucato, Nicola Petrosillo, Gianluigi Biava, Timothy M Uyeki, Giuseppe Ippolito
BACKGROUND: During the 2013-2016 West Africa Ebola virus disease (EVD) epidemic, some EVD patients, mostly health care workers, were evacuated to Europe and the USA. CASE PRESENTATION: In May 2015, a 37-year old male nurse contracted Ebola virus disease in Sierra Leone. After Ebola virus detection in plasma, he was medically-evacuated to Italy. At admission, rhabdomyolysis was clinically and laboratory-diagnosed and was treated with aggressive hydration, oral favipiravir and intravenous investigational monoclonal antibodies against Ebola virus...
August 30, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28839909/vedolizumab-early-experience-and-medium-term-outcomes-from-two-uk-tertiary-ibd-centres
#16
Mark A Samaan, Polychronis Pavlidis, Emma Johnston, Ben Warner, Jonathan Digby-Bell, Ioannis Koumoutsos, Steven Fong, Rimma Goldberg, Kamal Patel, Shraddha Gulati, Lucy Medcalf, Marlene Sastrillo, Cordella Brown-Clarke, Johanna Bidewell-Sullivan, Katrina Forsyth, Emma Lee, Anna Stanton, Julie Duncan, Guy Chung-Faye, Patrick Dubois, Nick Powell, Simon Anderson, Jeremy Sanderson, Bu'Hussain Hayee, Peter M Irving
OBJECTIVE: To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting. DESIGN: Retrospective cohort study using prospectively maintained clinical records. SETTING: Two UK tertiary inflammatory bowel disease (IBD) centres. PATIENTS: Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015. INTERVENTION: Vedolizumab, a monoclonal antibody to α-4 β-7 integrins that selectively inhibit leucocyte migration into the gut...
July 2017: Frontline Gastroenterology
https://www.readbyqxmd.com/read/28817679/increased-half-life-and-enhanced-potency-of-fc-modified-human-pcsk9-monoclonal-antibodies-in-primates
#17
Yijun Shen, Hua Li, Li Zhao, Gang Li, Ben Chen, Qingsong Guo, Bei Gao, Jinsong Wu, Tong Yang, Li Jin, Yong Su
Blocking proprotein convertase subtilisin kexin type 9 (PCSK9) binding to low-density lipoprotein receptor (LDLR) can profoundly lower plasma LDL levels. Two anti-PCKS9 monoclonal antibodies (mAbs), alirocumab and evolocumab, were approved by the FDA in 2015. The recommended dose is 75 mg to 150 mg every two weeks for alirocumab and 140mg every two weeks or 420 mg once a month for evolocumab. This study attempted to improve the pharmacokinetic properties of F0016A, an IgG1 anti-PCKS9 mAb, to generate biologically superior molecules...
2017: PloS One
https://www.readbyqxmd.com/read/28817390/hypoalbuminemia-is-a-predictive-factor-for-fistula-formation-in-recurrent-cervical-cancer
#18
Lavanya H Palavalli Parsons, Brandon Roane, Dustin B Manders, Debra L Richardson, Siobhan M Kehoe, Matthew Carlson, David S Miller, Jayanthi S Lea
OBJECTIVE: Antivascular endothelial growth factor monoclonal antibodies inhibit tumor angiogenesis, consequently impeding the recruitment of new vasculature to existing and new tumor lesions. We sought to evaluate toxicities in women with recurrent cervical cancer after receiving bevacizumab combination chemotherapy. METHODS: A review was conducted of women with recurrent and metastatic cervical cancer who were treated with salvage chemotherapy with or without bevacizumab between 2005 and 2015...
August 16, 2017: American Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28793981/attitudes-of-crohn-s-disease-patients-infodemiology-case-study-and-sentiment-analysis-of-facebook-and-twitter-posts
#19
Marco Roccetti, Gustavo Marfia, Paola Salomoni, Catia Prandi, Rocco Maurizio Zagari, Faustine Linda Gningaye Kengni, Franco Bazzoli, Marco Montagnani
BACKGROUND: Data concerning patients originates from a variety of sources on social media. OBJECTIVE: The aim of this study was to show how methodologies borrowed from different areas including computer science, econometrics, statistics, data mining, and sociology may be used to analyze Facebook data to investigate the patients' perspectives on a given medical prescription. METHODS: To shed light on patients' behavior and concerns, we focused on Crohn's disease, a chronic inflammatory bowel disease, and the specific therapy with the biological drug Infliximab...
August 9, 2017: JMIR Public Health and Surveillance
https://www.readbyqxmd.com/read/28792162/immunological-subtypes-of-acute-lymphoblastic-leukemia-beyond-morphology-experience-from-kidwai-state-cancer-institute-bengaluru-india
#20
Namrata N Rajkumar, Raghavendra H Vijay
INTRODUCTION: Acute lymphoblastic leukemia (ALL) is disease of lymphoid precursors and is the most common cancer. Diagnosis of ALL is made by evaluating morphology and flowcytometric Immunophenotyping (FCI)and is an important adjunct in diagnosis and determining treatment in ALL, with availability of extensive monoclonal antibodies in the recent years there is tremendous progress in the field of FCI, and is a requirement by World Health Organisation for the classification of acute lymphoblastic Leukemia...
July 2017: Journal of the Association of Physicians of India
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