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2015 monoclonal antibodies

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https://www.readbyqxmd.com/read/28346048/mabdelivery-administration-routes-for-antibody-therapy-third-labex-mabimprove-industrial-workshop-july-2-2015-tours-france
#1
Elsa Bodier-Montagutelli, Renaud Respaud, Hervé Watier, Audrey Guillon-Munos
The annual "LabEx MAbImprove Industrial Workshops" are primarily intended to provide a comprehensive view about topics of interest for the pharmaceutical industry to scientists involved in research on therapeutic antibodies. The third workshop in this series, held July 2, 2015 in Tours, was dedicated to the optimization of delivery, namely all processes leading monoclonal antibodies to reach their target site. The commonly used intravenous (IV) route, although advantageous in terms of pharmacokinetics and pharmacodynamics, presents some disadvantages in terms of patients' convenience, therapeutic target access or treatment cost...
February 28, 2017: MAbs
https://www.readbyqxmd.com/read/28328015/pcsk9-inhibitor-access-barriers-issues-and-recommendations-improving-the-access-process-for-patients-clinicians-and-payers
#2
REVIEW
Seth J Baum, Peter P Toth, James A Underberg, Paul Jellinger, Joyce Ross, Katherine Wilemon
The proprotein convertase subtilisin/kexin type 9 inhibitors or monoclonal antibodies likely represent the greatest advance in lipid management in 30 years. In 2015 the US Food and Drug Administration approved both alirocumab and evolocumab for high-risk patients with familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease requiring additional lowering of low-density lipoprotein cholesterol. Though many lipid specialists, cardiovascular disease prevention experts, endocrinologists, and others prescribed the drugs on label, they found their directives denied 80% to 90% of the time...
March 22, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28270583/a-reverse-genetics-platform-that-spans-the-zika-virus-family-tree
#3
Douglas G Widman, Ellen Young, Boyd L Yount, Kenneth S Plante, Emily N Gallichotte, Derek L Carbaugh, Kayla M Peck, Jessica Plante, Jesica Swanstrom, Mark T Heise, Helen M Lazear, Ralph S Baric
Zika virus (ZIKV), a mosquito-borne flavivirus discovered in 1947, has only recently caused large outbreaks and emerged as a significant human pathogen. In 2015, ZIKV was detected in Brazil, and the resulting epidemic has spread throughout the Western Hemisphere. Severe complications from ZIKV infection include neurological disorders such as Guillain-Barré syndrome in adults and a variety of fetal abnormalities, including microcephaly, blindness, placental insufficiency, and fetal demise. There is an urgent need for tools and reagents to study the pathogenesis of epidemic ZIKV and for testing vaccines and antivirals...
March 7, 2017: MBio
https://www.readbyqxmd.com/read/28266705/prognostic-impact-of-margin-status-in-liver-resections-for-colorectal-metastases-after-bevacizumab
#4
K Sasaki, G A Margonis, N Andreatos, A Wilson, M Weiss, C Wolfgang, T N Sergentanis, G Polychronidis, J He, T M Pawlik
BACKGROUND: Margin status with resection of colorectal liver metastasis (CRLM) was an important prognostic factor in the years before the introduction of biological chemotherapy. This study examined outcomes following CRLM resection in patients who received neoadjuvant chemotherapy with or without the monoclonal antiangiogenic antibody bevacizumab. METHODS: Patients who underwent surgery for CRLM at the Johns Hopkins Hospital between 2000 and 2015 were identified from an institutional database...
March 7, 2017: British Journal of Surgery
https://www.readbyqxmd.com/read/28213687/ofatumumab-for-the-treatment-of-childhood-nephrotic-syndrome
#5
Chia-Shi Wang, Rochelle Schmidt Liverman, Rouba Garro, Roshan Punnoose George, Anastacia Glumova, Alana Karp, Stephanie Jernigan, Barry Warshaw
BACKGROUND: Ofatumumab is a humanized anti-CD20 monoclonal antibody that has recently garnered interest as a potential therapeutic agent for nephrotic syndrome. We report our center's experience in administering ofatumumab to five pediatric patients with idiopathic nephrotic syndrome. METHODS: Between March 2015 and November 2016, five patients were treated with ofatumumab. One patient had post-transplant recurrent focal segmental glomerulosclerosis (FSGS) which had been resistant to plasmapheresis and numerous immunosuppressive agents...
February 17, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28203341/new-monoclonal-antibodies-on-the-horizon-in-multiple-myeloma
#6
REVIEW
Elizabeth K O'Donnell, Noopur S Raje
Across all cancers, monoclonal antibodies have emerged as a potential strategy for cancer therapy. Monoclonal antibodies target antigens expressed on the surface of cancer cells and accessory cells. This targeted approach uses the host's immune system to promote the killing of cancer cells. Multiple myeloma (MM) is the second most common hematologic malignancy that remains incurable in the majority of patients. The treatment of MM has evolved dramatically over the past decade and continues to evolve with the approval of four new drugs in 2015...
February 2017: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/28185460/-daratumumab-hope-for-myeloma-patients-a-challenge-for-clinical-laboratories
#7
T Jelínek, M Kořístka, Z Čermáková, R Hájek
Monoclonal antibodies represent a standard part in the treatment of oncologic patients, but their efficacy in multiple myeloma used to be unsatisfactory. Daratumumab monotherapy was approved by the American FDA in 2015, after unprecedented results were obtained in a heavily pre-treated group of patients. In 2016 daratumumab was approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of myeloma patients who have received at least one prior therapy.The toxicity of the drug is low, and is dominated by infusion-related reactions in more or less half of patients...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/28174515/upregulation-of-bcl-2-and-its-promoter-signals-in-cd4-t-cells-during-neuromyelitis-optica-remission
#8
Tao Yang, Su Wang, Xiao Yang, Qi Zheng, Lei Wang, Qian Li, Mingyan Wei, Zongpan Du, Yongping Fan
The homeostatic balance between production and elimination of CD4+ T cells in peripheral blood plays an important role in patients with neuromyelitis optica (NMO). The objective of the present study was to evaluate the anti-apoptosis genes Bcl-2 and its promoter signal (nuclear factor kappa-light-chain-enhancer of activated B cells, NFκB) in CD4+ T cells. Healthy subjects (HS, n = 25) and patients with multiple sclerosis (MS) (n = 25) and NMO (n = 30) in remission were consecutively enrolled in this prospective study between May and December 2015...
2017: Frontiers in Neuroscience
https://www.readbyqxmd.com/read/28169436/vedolizumab-exposure-in-pregnancy-outcomes-from-clinical-studies-in-inflammatory-bowel-disease
#9
U Mahadevan, S Vermeire, K Lasch, B Abhyankar, F Bhayat, A Blake, M Dubinsky
BACKGROUND: Vedolizumab is a gut-selective immunoglobulin G1 monoclonal antibody to α4 β7 integrin for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Prospective clinical studies of vedolizumab in pregnancy have not been conducted; therefore, existing safety data of vedolizumab in pregnancy were examined. AIM: To assess pregnancy outcomes in females and partners of males who received vedolizumab. METHODS: All pregnancy data collected during the clinical programme (from 14 May 2007 to 27 June 2013) and in the post-marketing setting (to 19 November 2015) were analysed...
February 7, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28157706/the-level-of-epidermal-growth-factor-receptors-expression-is-correlated-with-the-advancement-of-colorectal-adenoma-validation-of-a-surface-biomarker
#10
Nicolas Williet, Carmen Adina Petcu, Leslie Rinaldi, Michèle Cottier, Emilie Del Tedesco, Léa Clavel, Olivier Dumas, Camille Jarlot, Nadia Bouarioua, Xavier Roblin, Michel Peoc'h, Jean-Marc Phelip
INTRODUCTION: Data about the expression of Epidermal Growth Factor Receptors (EGFRs) in colorectal adenomas remain scarce. RESULTS: 101 patients were enrolled including 53 controls. All adenomas (n = 38) and CRC (n = 5) were EGFR positive. Hyperplastic polyps (HP) (n = 8) and control colons (n = 53) were EGFR negative in half of cases (p < 0.0001). A well significant gradient of increased EGFR expression was observed between adjacent mucosa, hyperplastic lesions, low grade dysplasia (LGD) (n = 30), high grade dysplasia (HGD) adenomas (n = 9) and cancers (p < 0...
February 1, 2017: Oncotarget
https://www.readbyqxmd.com/read/28151709/progress-and-paradigms-in-multiple-myeloma
#11
EDITORIAL
Kenneth C Anderson
Remarkable progress has been achieved in multiple myeloma, and patient median survival has been extended 3- to 4-fold. Specifically, there have been 18 newly approved treatments for multiple myeloma in the past 12 years, including seven in 2015, and the treatment paradigm and patient outcome have been transformed. The definition of patients benefitting from these therapies has been broadened. Response criteria now include minimal residual disease (MRD), assessed in bone marrow by multicolor flow cytometry or sequencing, and by imaging for extramedullary disease...
November 15, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28143927/angptl4-does-not-control-hyperglucagonemia-or-%C3%AE-cell-hyperplasia-following-glucagon-receptor-inhibition
#12
Haruka Okamoto, Katie Cavino, Erqian Na, Elizabeth Krumm, Steven Kim, Panayiotis E Stevis, Joyce Harp, Andrew J Murphy, George D Yancopoulos, Jesper Gromada
Genetic disruption or pharmacologic inhibition of glucagon signaling effectively lowers blood glucose but results in compensatory glucagon hypersecretion involving expansion of pancreatic α-cell mass. Ben-Zvi et al. recently reported that angiopoietin-like protein 4 (Angptl4) links glucagon receptor inhibition to hyperglucagonemia and α-cell proliferation [Ben-Zvi et al. (2015) Proc Natl Acad Sci USA 112:15498-15503]. Angptl4 is a secreted protein and inhibitor of lipoprotein lipase-mediated plasma triglyceride clearance...
March 7, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28127361/microscopic-and-molecular-detection-of-cryptosporidium-andersoni-and-cryptosporidium-xiaoi-in-wastewater-samples-of-tehran-province-iran
#13
Kareem Hatam-Nahavandi, Mehdi Mohebali, Amir-Hossein Mahvi, Hossein Keshavarz, Hamid-Reza Najafian, Hamed Mirjalali, Sasan Rezaei, Mostafa Rezaeian
BACKGROUND: As a waterborne pathogen, Cryptosporidium is one of the most common causes of gastroenteritis in human and hoofed livestock animals. This study aimed to investigate the distribution of Cryptosporidium spp. in human and livestock wastewaters in Iran, by the 18S rRNA sequence analysis. METHODS: A total of 54 raw wastewater samples collected from three urban treatment plants and two slaughterhouses during 2014-2015 in Tehran, Iran. The presence of the Cryptosporidium oocysts was assessed by immunofluorescence with monoclonal antibodies...
October 2016: Iranian Journal of Parasitology
https://www.readbyqxmd.com/read/28115683/validation-of-a-monoclonal-antibody-based-immunofluorescent-assay-to-detect-burkholderia-pseudomallei-in-blood-cultures
#14
Adul Dulsuk, Suporn Paksanont, Adisak Sangchankoom, Peeraya Ekchariyawat, Rungnapa Phunpang, Yaowaruk Jutrakul, Narisara Chantratita, T Eoin West
BACKGROUND: Identification of Burkholderia pseudomallei, the cause of melioidosis, using routine methods takes several days. Use of a monoclonal antibody-based immunofluorescent assay (IFA) on positive blood cultures may speed diagnosis. METHODS: We tested the diagnostic accuracy of the IFA on 545 blood cultures positive for Gram-negative organisms at Udon Thani Hospital, Thailand, between June 2015 and August 2016. RESULTS: Sensitivity of the IFA was 100% and specificity was 99...
January 22, 2017: Transactions of the Royal Society of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28078656/biosimilars-for-the-treatment-of-cancer-a-systematic-review-of-published-evidence
#15
REVIEW
Ira Jacobs, Reginald Ewesuedo, Sadiq Lula, Charles Zacharchuk
BACKGROUND: Biologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access. OBJECTIVES: The purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer. METHODS: MEDLINE(®), Embase(®), and ISI Web of Science(®) databases were searched to September 2015...
February 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28072766/the-impact-of-body-composition-parameters-on-ipilimumab-toxicity-and-survival-in-patients-with-metastatic-melanoma
#16
Louise E Daly, Derek G Power, Áine O'Reilly, Paul Donnellan, Samantha J Cushen, Kathleen O'Sullivan, Maria Twomey, David P Woodlock, Henry P Redmond, Aoife M Ryan
BACKGROUND: Body composition is an important predictor of drug toxicity and outcome. Ipilimumab (Ipi), a monoclonal antibody used to treat metastatic melanoma, has specific toxicities. No validated biomarkers that predict Ipi toxicity and efficacy exist. Also, the impact of Ipi on body composition has not been established. METHODS: Patients with metastatic melanoma treated with Ipi between 2009 and 2015 were included. Body composition was assessed by computed tomography at baseline and after four cycles of Ipi...
January 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28066098/novel-strategies-for-alzheimer-s-disease-treatment-an-overview-of-anti-amyloid-beta-monoclonal-antibodies
#17
Katarzyna Rygiel
Alzheimer's disease (AD) is a multifactorial, progressive neurodegenerative disorder with a poor prognosis, and thus, novel therapies for AD are certainly needed in a growing population of elderly patients or asymptomatic individuals, who are at risk for AD, worldwide. It has been established that some AD biomarkers such as amyloid-beta load in the brain, precede the onset of the disease, by approximately 20 years. Therefore, the therapy to prevent or effectively treat AD has to be initiated before the emergence of symptoms...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28060563/efficacy-and-safety-of-elotuzumab-for-the-treatment-of-multiple-myeloma
#18
REVIEW
Maria Gavriatopoulou, Evangelos Terpos, Efstathios Kastritis, Meletios A Dimopoulos
Multiple myeloma (MM) is the second most common hematologic malignancy and despite significant outcome improvements with novel agents, the majority of patients will eventually relapse and develop treatment resistance. Immunotherapy is emerging as a promising therapeutic approach in MM. Areas covered: Elotuzumab is a monoclonal antibody directly targeting the SLAMF7 receptor, expressed on normal and malignant plasma cells. Elotuzumab has no meaningful antimyeloma activity when given as monotherapy to patients with relapsed or refractory MM (RRMM)...
February 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28056114/diagnosis-and-management-of-waldenstr%C3%A3-m-macroglobulinemia-mayo-stratification-of-macroglobulinemia-and-risk-adapted-therapy-msmart-guidelines-2016
#19
Prashant Kapoor, Stephen M Ansell, Rafael Fonseca, Asher Chanan-Khan, Robert A Kyle, Shaji K Kumar, Joseph R Mikhael, Thomas E Witzig, Michelle Mauermann, Angela Dispenzieri, Sikander Ailawadhi, A Keith Stewart, Martha Q Lacy, Carrie A Thompson, Francis K Buadi, David Dingli, William G Morice, Ronald S Go, Dragan Jevremovic, Taimur Sher, Rebecca L King, Esteban Braggio, Ann Novak, Vivek Roy, Rhett P Ketterling, Patricia T Greipp, Martha Grogan, Ivana N Micallef, P Leif Bergsagel, Joseph P Colgan, Nelson Leung, Wilson I Gonsalves, Yi Lin, David J Inwards, Suzanne R Hayman, Grzegorz S Nowakowski, Patrick B Johnston, Steven J Russell, Svetomir N Markovic, Steven R Zeldenrust, Yi L Hwa, John A Lust, Luis F Porrata, Thomas M Habermann, S Vincent Rajkumar, Morie A Gertz, Craig B Reeder
Importance: Waldenström macroglobulinemia (WM), an IgM-associated lymphoplasmacytic lymphoma, has witnessed several practice-altering advances in recent years. With availability of a wider array of therapies, the management strategies have become increasingly complex. Our multidisciplinary team appraised studies published or presented up to December 2015 to provide consensus recommendations for a risk-adapted approach to WM, using a grading system. Observations: Waldenström macroglobulinemia remains a rare, incurable cancer, with a heterogeneous disease course...
January 5, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28044264/clinicopathological-associations-of-k-ras-and-n-ras-mutations-in-indonesian-colorectal-cancer-cohort
#20
Michael Levi, Gintang Prayogi, Farid Sastranagara, Edi Sudianto, Grace Widjajahakim, Winiarti Gani, Albert Mahanadi, Jocelyn Agnes, Bela Haifa Khairunisa, Ahmad R Utomo
BACKGROUND: K-RAS and recently N-RAS gene mutation testing are mandatory requirements prior to anti-epidermal growth factor receptor (EGFR) monoclonal antibody treatment of metastatic CRC. Mutation prevalence and distribution in Indonesian colorectal cancer (CRC) are not known. METHODS: Combined methods of PCR high-resolution melt (HRM), restriction fragment length polymorphism (RFLP), and direct DNA sequencing were used to genotype exons 2, 3, and 4 of both K-RAS and N-RAS genes for routine clinical testing of CRC patients...
January 3, 2017: Journal of Gastrointestinal Cancer
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