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https://www.readbyqxmd.com/read/28230262/evaluation-of-the-immunogenicity-of-the-dabigatran-reversal-agent-idarucizumab-during-phase-i-studies
#1
Stephen Norris, Steven Ramael, Ippei Ikushima, Wouter Haazen, Akiko Harada, Viktoria Moschetti, Susumu Imazu, Paul A Reilly, Benjamin Lang, Joachim Stangier, Stephan Glund
AIMS: Idarucizumab, a humanized monoclonal anti-dabigatran antibody fragment, is effective in emergency reversal of dabigatran anticoagulation. Pre-existing and treatment-emergent anti-idarucizumab antibodies (antidrug antibodies; ADA) may affect the safety and efficacy of idarucizumab. This analysis characterized the pre-existing and treatment-emergent ADA and assessed their impact on the pharmacokinetics and pharmacodynamics (PK/PD) of idarucizumab. METHODS: Data were pooled from three phase I, randomized, double-blind idarucizumab studies in healthy Caucasian; elderly, renally impaired subjects; and healthy Japanese subjects...
February 23, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28230065/in-vivo-evaluation-of-a-novel-format-of-a-bivalent-her3-targeting-and-albumin-binding-therapeutic-affibody-construct
#2
Tarek Z Bass, Maria Rosestedt, Bogdan Mitran, Fredrik Y Frejd, John Löfblom, Vladimir Tolmachev, Stefan Ståhl, Anna Orlova
Overexpression of human epidermal growth factor receptor 3 (HER3) is involved in resistance to several therapies for malignant tumours. Currently, several anti-HER3 monoclonal antibodies are under clinical development. We introduce an alternative approach to HER3-targeted therapy based on engineered scaffold proteins, i.e. affibody molecules. We designed a small construct (22.5 kDa, denoted 3A3), consisting of two high-affinity anti-HER3 affibody molecules flanking an albumin-binding domain ABD, which was introduced for prolonged residence in circulation...
February 23, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28229892/safety-and-efficacy-of-opicinumab-in-acute-optic-neuritis-renew-a-randomised-placebo-controlled-phase-2-trial
#3
Diego Cadavid, Laura Balcer, Steven Galetta, Orhan Aktas, Tjalf Ziemssen, Ludo Vanopdenbosch, Jette Frederiksen, Mark Skeen, Glenn J Jaffe, Helmut Butzkueven, Focke Ziemssen, Luca Massacesi, Yi Chai, Lei Xu, Stefanie Freeman
BACKGROUND: The human monoclonal antibody opicinumab (BIIB033, anti-LINGO-1) has shown remyelinating activity in preclinical studies. We therefore assessed the safety and tolerability, and efficacy of opicinumab given soon after a first acute optic neuritis episode. METHODS: This randomised, double-blind, placebo-controlled, phase 2 study (RENEW) was done at 33 sites in Australia, Canada, and Europe in participants (aged 18-55 years) with a first unilateral acute optic neuritis episode within 28 days from study baseline...
March 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28229371/overall-survival-and-metastasis-resections-in-patients-with-metastatic-colorectal-cancer-using-electronic-medical-records
#4
Eetu Heervä, Maija Lavonius, Panu Jaakkola, Heikki Minn, Raija Ristamäki
PURPOSE: Treatment for patients with metastatic colorectal cancer is chemotherapy commonly combined with monoclonal antibodies against vascular endothelial growth factor (bevacizumab) or epidermal growth factor receptor (cetuximab or panitumumab), the efficacy of which has been proven in randomized controlled trials. The objective of the current retrospective study was to analyze the impact of targeted therapy, adverse events, and dose reduction on overall survival (OS) and metastasis resection rates...
February 23, 2017: Journal of Gastrointestinal Cancer
https://www.readbyqxmd.com/read/28229176/denosumab-for-the-treatment-of-mastocytosis-related-osteoporosis-a-case-series
#5
Giovanni Orsolini, Irene Gavioli, Gaia Tripi, Ombretta Viapiana, Davide Gatti, Luca Idolazzi, Roberta Zanotti, Maurizio Rossini
The purpose of this study was to investigate the therapeutic effect of denosumab, an anti-RANKL monoclonal antibody for the treatment of bone loss in indolent systemic mastocytosis (ISM) patients intolerant to bisphosphonates. Four patients underwent upon informed consent a treatment with denosumab 60 mg administered subcutaneously every 6 months with the same regimen used for postmenopausal osteoporosis. Bone mineral density (BMD) was measured at lumbar and femoral sites at baseline and after 1 year. C-terminal telopeptide of collagen type I (CTX), bone alkaline phosphatase (bALP) and tryptase serum level were determined at baseline and after 12 months with fasting blood samples withdrawals...
February 22, 2017: Calcified Tissue International
https://www.readbyqxmd.com/read/28228781/denosumab-is-really-effective-in-the-treatment-of-osteoporosis-secondary-to-hypogonadism-in-prostate-carcinoma-patients-a-prospective-randomized-multicenter-international-study
#6
Carlo Doria, Paolo Tranquilli Leali, Federico Solla, Gianluca Maestretti, Massimo Balsano, Robero Mario Scarpa
INTRODUCTION: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. The best defense against osteoporosis in prostate cancer is to identify patients with a high risk for fracture during the first clinical visit, select an effective anti-osteoporosis agent, and advise the patient to change his lifestyle and diet to prevent further bone loss. New agents include denosumab, a human monoclonal antibody that inhibits the RANK ligand (RANKL). RANKL promotes the formation, activity, and survival of osteoclasts and, thus, supports the breakdown of bone...
September 2016: Clinical Cases in Mineral and Bone Metabolism
https://www.readbyqxmd.com/read/28228578/proof-of-concept-randomized-trial-of-the-monoclonal-antibody-gsk249320-versus-placebo-in-stroke-patients
#7
Steven C Cramer, Lori A Enney, Colleen K Russell, Monica Simeoni, Thomas R Thompson
BACKGROUND AND PURPOSE: One class of poststroke restorative therapy focuses on promoting axon outgrowth by blocking myelin-based inhibitory proteins such as myelin-associated glycoprotein. The purpose of the current study was to extend preclinical and clinical findings of GSK249320, a humanized monoclonal antibody to myelin-associated glycoprotein with disabled Fc region, to explore effects on motor outcomes post-stroke. METHODS: In this phase IIb double-blind, randomized, placebo-controlled study, patients at 30 centers with ischemic stroke 24 to 72 hours prior and gait deficits were randomized to 2 IV infusions of GSK249320 or placebo...
February 22, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28226418/omalizumab-for-the-treatment-of-chronic-idiopathic-urticaria-systematic-review-of-the-literature
#8
Alessandro Tonacci, Lucia Billeci, Giovanni Pioggia, Michele Navarra, Sebastiano Gangemi
Omalizumab is recombinant humanized monoclonal antibody to immunoglobulin E. Guidelines for the treatment of chronic idiopathic urticaria (also known as chronic spontaneous urticaria) recommend the use of omalizumab as third-line therapy in addition to high doses of histamine receptor type 1 (H1 ) antihistamines when they are unsuccessful as first- and second-line therapy. We performed a systematic review of the literature to identify studies that evaluated the efficacy of omalizumab for the treatment of chronic idiopathic urticaria, both in controlled and real-world settings, to assess its potential role as a preferred therapy...
February 22, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28225293/rituximab-associated-progressive-multifocal-leukoencephalopathy
#9
Juraj Sokol, Lenka Lisá, Jana Zeleňáková, Tomáš Balhárek, Ivana Plameňová, Ján Staško, Peter Kubisz
The definition "Progressive Multifocal Leukoencephalopathy" (PML) was first used in 1958 to describe a fatal demyelinating central nervous system (CNS) disease in patients with lymphoproliferative disorders. In 1971, the virus responsible for the disease was isolated and named John Cunningham virus (JCV). We present a rare case of a 62-year-old male with chronic lymphocytic leukemia and PML. In our work, we discuss the diagnostic and therapeutic challenges and offer suggestions for preventing PML development...
2017: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/28224486/human-herpes-virus-6-encephalitis-causing-severe-anterograde-amnesia-associated-with-rituximab-azathioprine-and-prednisolone-combination-therapy-for-dermatomyositis
#10
Thomas Baumer, Charlie Fry, Sebastian Luppe, Harsha Gunawardena, Kasia Sieradzan
Human herpes virus-6 (HHV-6) reactivation is a well-recognised complication following haematological stem cell transplantation, but it is novel in the context of combination immunomodulatory therapy for autoimmune disease. We report a case of severe anterograde amnesia caused by HHV-6 encephalitis in a young female patient on rituximab, azathioprine and prednisolone for dermatomyositis (DM). The use of targeted biologic treatments for systemic autoimmune connective tissue diseases (CTDs) is increasing, particularly when refractory to conventional management...
February 21, 2017: Journal of Neurovirology
https://www.readbyqxmd.com/read/28224235/oral-mucosal-changes-induced-by-anticancer-targeted-therapies-and-immune-checkpoint-inhibitors
#11
REVIEW
Emmanuelle Vigarios, Joel B Epstein, Vincent Sibaud
Development of biological targeted therapies and immune checkpoint inhibitors has redefined the treatment for many cancers; however, the increasing use of new protocols has led to physicians observing a new spectrum of toxicities. To date, oral adverse events induced by these new anticancer therapies have been mainly reported using nonspecific terminology ("stomatitis," "mucosal inflammation," "mucositis") and remain poorly characterized, with the exception of mammalian target of rapamycin (mTOR) inhibitor-associated stomatitis...
February 22, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28223229/theranostic-of-biopharmaceuticals
#12
REVIEW
Benjamin Chaigne, Hervé Watier
Monoclonal antibodies (mAbs) and fusion proteins with an Fc portion of immunoglobulin G (IgG) are emblematic of the remarkable expansion of biopharmaceuticals. Despite their biological origin, these products display an interindividual variability in their efficacy and/or side effects, which must be taken into consideration. Biological monitoring allowing for adapted prescription and dose adjustments may lead to therapeutic optimization and limitation of the high costs of these drugs. Herein, we review the biological theranostic of mAbs and Fc fusion proteins, including pre-treatment analyses, monitoring of efficacy, therapeutic drug monitoring, and monitoring of side effects...
February 13, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28223185/nanomedicine-as-a-potent-strategy-in-melanoma-tumor-microenvironment
#13
REVIEW
Vincent Pautu, Daniela Leonetti, Elise Lepeltier, Nicolas Clere, Catherine Passirani
Melanoma originated from melanocytes is the most aggressive type of skin cancer. Despite considerable progresses in clinical treatment with the discovery of BRAF or MEK inhibitors and monoclonal antibodies, the durability of response to treatment is often limited to the development of acquired resistance and systemic toxicity. The limited success of conventional treatment highlights the importance of understanding the role of melanoma tumor microenvironment in tumor developement and drug resistance. Nanoparticles represent a promising strategy for the development of new cancer treatments able to improve the bioavailability of drugs and increase their penetration by targeting specifically tumours cells and/or tumour environment...
February 18, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28223071/therapeutic-antibody-targeting-of-indoleamine-2-3-dioxygenase-ido2-inhibits-autoimmune-arthritis
#14
Lauren M F Merlo, Samantha Grabler, James B DuHadaway, Elizabeth Pigott, Kaylend Manley, George C Prendergast, Lisa D Laury-Kleintop, Laura Mandik-Nayak
Rheumatoid arthritis (RA) is a debilitating inflammatory autoimmune disease with no known cure. Recently, we identified the immunomodulatory enzyme indoleamine-2,3-dioxygenase 2 (IDO2) as an essential mediator of autoreactive B and T cell responses driving RA. However, therapeutically targeting IDO2 has been challenging given the lack of small molecules that specifically inhibit IDO2 without also affecting the closely related IDO1. In this study, we develop a novel monoclonal antibody (mAb)-based approach to therapeutically target IDO2...
February 18, 2017: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/28222530/generation-and-partial-characterization-of-rabbit-monoclonal-antibody-to-amyloid-%C3%AE-peptide-1-37-a%C3%AE-37
#15
Pankaj D Mehta, Jean-Francois Blain, Emily A Freeman, Bruce A Patrick, Marc Barshatzky, Lori A Hrdlicka, Sangita P Mehta, Janusz Frackowiak, Bozena Mazur-Kolecka, Jerzy Wegiel, Holger Patzke, David L Miller
Secreted soluble amyloid-β 1-37 (Aβ37) peptide is one of the prominent Aβ forms next to Aβ40, and is found in cerebrospinal fluid (CSF) and blood. Recent studies have shown the importance of quantitation of CSF Aβ37 levels in combination with Aβ38, Aβ40, and Aβ42 to support the diagnosis of patients with probable Alzheimer's disease (AD), and the value of antibody to Aβ37 to facilitate drug discovery studies. However, the availability of reliable and specific monoclonal antibody to Aβ37 is very limited...
February 10, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28220932/a-phase-2-study-of-simtuzumab-in-patients-with-primary-post-polycythaemia-vera-or-post-essential-thrombocythaemia-myelofibrosis
#16
Srdan Verstovsek, Michael R Savona, Ruben A Mesa, Hua Dong, Julia D Maltzman, Shringi Sharma, Jeffrey Silverman, Stephen T Oh, Jason Gotlib
Simtuzumab, a monoclonal antibody inhibitor of extracellular matrix enzyme lysyl oxidase-like-2, showed preclinical promise and was well tolerated in clinical studies. A phase 2, open-label study of simtuzumab was conducted in patients with primary myelofibrosis (MF), post-polycythaemia vera MF and post-essential thrombocythaemia MF. Fifty-four patients were randomized to receive simtuzumab alone (200 or 700 mg [n = 12 each group]) or simtuzumab (200 or 700 mg) with ruxolitinib (n = 15 each group) for 24 weeks...
February 21, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28220124/in-vivo-efficacy-of-umbilical-cord-blood-stem-cell-derived-nk-cells-in-the-treatment-of-metastatic-colorectal-cancer
#17
John P Veluchamy, Silvia Lopez-Lastra, Jan Spanholtz, Fenna Bohme, Nina Kok, Daniëlle A M Heideman, Henk M W Verheul, James P Di Santo, Tanja D de Gruijl, Hans J van der Vliet
Therapeutic monoclonal antibodies against the epidermal growth factor receptor (EGFR) act by inhibiting EGFR downstream signaling and by eliciting a natural killer (NK) cell-mediated antitumor response. The IgG1 mAb cetuximab has been used for treatment of RAS(wt) metastatic colorectal cancer (mCRC) patients, showing limited efficacy. In the present study, we address the potential of adoptive NK cell therapy to overcome these limitations investigating two allogeneic NK cell products, i.e., allogeneic activated peripheral blood NK cells (A-PBNK) and umbilical cord blood stem cell-derived NK cells (UCB-NK)...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28220020/randomized-phase-ii-study-of-ramucirumab-or-icrucumab-in-combination-with-capecitabine-in-patients-with-previously-treated-locally-advanced-or-metastatic-breast-cancer
#18
Linda T Vahdat, Rachel Layman, Denise A Yardley, William Gradishar, Mohamad A Salkeni, Anil Abraham Joy, Agustin A Garcia, Patrick Ward, James Khatcheressian, Joseph Sparano, Gladys Rodriguez, Shande Tang, Ling Gao, Rita P Dalal, John Kauh, Kathy Miller
BACKGROUND: Icrucumab (ICR) and ramucirumab (RAM) bind vascular endothelial growth factor (VEGF) receptors 1 and 2 (VEGFR-1 and -2), respectively. This open-label, randomized phase II study evaluated their efficacy and safety in combination with capecitabine (CAP) in patients with previously treated unresectable, locally advanced or metastatic breast cancer. METHODS: Patients were randomly assigned (1:1:1) to receive CAP (1,000 mg/m(2) orally twice daily, days 1-14) alone or in combination with RAM (10 mg/kg intravenously [IV], days 1 and 8) (RAM + CAP) or ICR (12 mg/kg IV, days 1 and 8) (ICR + CAP) every 21 days...
February 20, 2017: Oncologist
https://www.readbyqxmd.com/read/28219375/state-of-the-art-in-anti-cancer-mabs
#19
REVIEW
S M Chiavenna, J P Jaworski, A Vendrell
Following Milstein's discovery, the monoclonal antibodies (mAbs) became a basic tool for biomedical science. In cancer field, since the first mAb was approved by the FDA a great improvement took place making of them a therapeutic option for many cancer types in the current clinical practice. Today, mAbs are being developed to target different molecules with different mechanisms of action and its target potential is unlimited. However, this huge and fast growing new field needs to be organized to better understand the treatment options we have to confront different cancer diseases...
February 20, 2017: Journal of Biomedical Science
https://www.readbyqxmd.com/read/28218037/immunotoxin-a-new-tool-for-cancer-therapy
#20
Hossein Allahyari, Sahar Heidari, Mehdi Ghamgosha, Parvaneh Saffarian, Jafar Amani
Cancer is one of the main reasons of death in the most countries and in Iran. Immunotherapy quickly became one of the best methods of cancer treatment, along with chemotherapy and radiation. "Immunotoxin Therapy" is a promising way of cancer therapy that is mentioned in this field. Immunotoxins are made from a toxin attaching to an antibody target proteins present on cancer cells. The first-generation immunotoxins were made of a full-length toxin attached to whole monoclonal antibodies. But, these immunotoxins could bind to normal cells...
February 2017: Tumour Biology: the Journal of the International Society for Oncodevelopmental Biology and Medicine
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