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https://www.readbyqxmd.com/read/29331635/sotatercept-with-long-term-extension-for-the-treatment-of-anaemia-in-patients-with-lower-risk-myelodysplastic-syndromes-a-phase-2-dose-ranging-trial
#1
Rami Komrokji, Guillermo Garcia-Manero, Lionel Ades, Thomas Prebet, David P Steensma, Joseph G Jurcic, Mikkael A Sekeres, Jesus Berdeja, Michael R Savona, Odile Beyne-Rauzy, Aspasia Stamatoullas, Amy E DeZern, Jacques Delaunay, Gautam Borthakur, Robert Rifkin, Thomas E Boyd, Abderrhamane Laadem, Bond Vo, Jennie Zhang, Marie Puccio-Pick, Kenneth M Attie, Pierre Fenaux, Alan F List
BACKGROUND: Myelodysplastic syndromes are characterised by ineffective erythropoiesis leading to anaemia. Sotatercept (ACE-011) is a novel activin receptor type IIA fusion protein that acts as a ligand trap to neutralise negative regulators of late-stage erythropoiesis. The aim of the study was to establish a safe and effective dose of sotatercept for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes. METHODS: This open-label, multicentre, dose-ranging, phase 2 trial took place at 11 treatment centres in the USA and France...
January 10, 2018: Lancet Haematology
https://www.readbyqxmd.com/read/29331634/of-blood-and-bone-the-sotatercept-adventure
#2
Valeria Santini
No abstract text is available yet for this article.
January 10, 2018: Lancet Haematology
https://www.readbyqxmd.com/read/29193906/detection-of-sotatercept-ace-011-in-human-serum-by-sar-page-and-western-single-blotting
#3
Christian Reichel, Letizia Farmer, Günter Gmeiner, Katja Walpurgis, Mario Thevis
A method for the detection of Sotatercept (ACE-011, ACVR2A-Fc) in human serum is presented. The method is a modification of a recently published protocol for Luspatercept (ACE-536, ACVR2B-Fc), another erythropoiesis stimulating fusion protein. Out of 27 tested antibodies against either the extracellular domain of ACVR2A or the full length protein, only 4 antibodies bound strongly enough to Sotatercept for usage with immunoprecipitation followed by SAR-PAGE and Western single blotting. The adapted protocol allows the detection of 0...
November 28, 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/29175022/biology-and-treatment-of-myeloma-related-bone-disease
#4
Evangelos Terpos, Dimitrios Christoulas, Maria Gavriatopoulou
Myeloma bone disease (MBD) is the most common complication of multiple myeloma (MM), resulting in skeleton-related events (SREs) such as severe bone pain, pathologic fractures, vertebral collapse, hypercalcemia, and spinal cord compression that cause significant morbidity and mortality. It is due to an increased activity of osteoclasts coupled to the suppressed bone formation by osteoblasts. Novel molecules and pathways that are implicated in osteoclast activation and osteoblast inhibition have recently been described, including the receptor activator of nuclear factor-kB ligand/osteoprotegerin pathway, activin-A and the wingless-type signaling inhibitors, dickkopf-1 (DKK-1) and sclerostin...
November 23, 2017: Metabolism: Clinical and Experimental
https://www.readbyqxmd.com/read/28958287/increasing-the-effectiveness-of-hematopoiesis-in-myelodysplastic-syndromes-erythropoiesis-stimulating-agents-and-transforming-growth-factor-%C3%AE-superfamily-inhibitors
#5
REVIEW
Anna Mies, Uwe Platzbecker
Patients with lower-risk myelodysplastic syndromes (MDS) are mainly affected by chronic anemia and fatigue. Treatment strategies aim to improve anemia and quality of life, as well as iron overload due to red blood cell transfusion support. To promote proliferation and differentiation of erythropoiesis, erythropoiesis-stimulating agents (ESAs) such as erythropoietin (EPO) and mimetics are applied as first-line therapy in a large fraction of lower-risk MDS patients. In general, ESAs yield favorable responses in about half of the patients, although responses are often short-lived...
July 2017: Seminars in Hematology
https://www.readbyqxmd.com/read/28929587/antibody-based-strategies-for-the-detection-of-luspatercept-ace-536-in-human-serum
#6
Christian Reichel, G Gmeiner, Mario Thevis
Luspatercept (ACE-536, ACVR2B-Fc), a fusion protein consisting of the extracellular domain of ActRIIB receptor and the Fc-part of human immunoglobulin G1 (IgG1), is currently under clinical development (Phase III). It stimulates the formation of red blood cells and hence may be misused by athletes for doping purposes in the future. Several antibody-based strategies for the detection of Luspatercept and other ACVR2B-Fc fusion proteins in human serum were evaluated (ELISA; IEF-, SDS-, and SAR-PAGE followed by Western blotting; immunoprecipitation)...
September 19, 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/28760302/developmental-therapeutics-in-myeloproliferative-neoplasms
#7
REVIEW
Prithviraj Bose, Srdan Verstovsek
The unprecedented success of the Janus kinase (JAK) 1/2 inhibitor ruxolitinib in myelofibrosis (MF) provided much-needed impetus for clinical drug development for the Philadelphia chromosome-negative myeloproliferative neoplasms. The survival benefit conferred by this agent, along with its marked efficacy with regard to spleen volume and symptom reduction, have made ruxolitinib the cornerstone of drug therapy in MF. However, there remain significant unmet needs in the treatment of patients with MF, and many novel classes of agents continue to be investigated in efforts to build on the progress made with ruxolitinib...
July 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28540737/investigational-drugs-in-phase-i-and-phase-ii-clinical-trials-for-thalassemia
#8
REVIEW
Irene Motta, Natalia Scaramellini, Maria Domenica Cappellini
Regular transfusion and iron chelation are the current treatment of severe forms of thalassemia. As a consequence of this demanding supportive treatment, there are several unmet therapeutic needs. Due to a deeper understanding in the pathophysiology of thalassemia, new therapeutic strategies have been developed that are now in pre-clinical and clinical trials. Areas covered: Activin receptor ligand traps (luspatercept and sotatercept), drugs targeting ineffective erythropoiesis, showed encouraging results in Phase I and II clinical trials...
July 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28443351/current-and-future-chemical-therapies-for-treating-anaemia-in-chronic-kidney-disease
#9
REVIEW
Francesco Locatelli, Lucia Del Vecchio, Maria Carmen Luise
Erythropoiesis-stimulating agents (ESAs) are not perfect, since they have potential side effects. Iron therapy is also receiving growing attention in recent years. Areas covered: We performed a literature search on PubMed using the following key words: anemia, chronic kidney disease, HIF stabilisers, sotatercept, actin traps, iron, iron-containing phosphate binders, iron dialysate. We reviewed new drugs that are under clinical development to obtain better safety and activity and/or easier and cheaper manufacturing processes in comparison to available ESAs...
June 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28092987/emerging-treatment-approaches-for-myeloma-related-bone-disease
#10
REVIEW
Maria Gavriatopoulou, Meletios A Dimopoulos, Efstathios Kastritis, Evangelos Terpos
Multiple myeloma is characterized by the presence of osteolytic lesions that leads to devastating skeletal-related events in the majority of patients. Myeloma bone disease is attributed to increased osteoclastic and suppressed osteoblastic activity. Areas covered: Bisphosphonates remain the main treatment option, however they have limitations on their own. Understanding the pathogenesis of myeloma bone disease may provide a roadmap for new therapeutic approaches. The pathway of RANKRANKLOPG pathway has revealed denosumab, a monoclonal antibody targeting RANKL as a novel emerging therapy for myeloma-related bone disease...
March 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/27921395/testing-for-the-erythropoiesis-stimulating-agent-sotatercept-ace-011-actriia-fc-in-serum-by-means-of-western-blotting-and-lc-hrms
#11
(no author information available yet)
No abstract text is available yet for this article.
November 2016: Drug Testing and Analysis
https://www.readbyqxmd.com/read/27883945/recent-advances-in-the-treatment-of-lower-risk-non-del-5q-myelodysplastic-syndromes-mds
#12
REVIEW
Antonio Almeida, Pierre Fenaux, Alan F List, Azra Raza, Uwe Platzbecker, Valeria Santini
Patients with lower-risk myelodysplastic syndromes (MDS) are affected primarily by symptoms of chronic anemia and fatigue rather than progression to acute myeloid leukemia. Severe thrombocytopenia, although less common in lower-risk MDS, is associated with increased risk of bleeding. For anemic patients, the principal aim of treatment is to improve anemia and decrease red blood cell transfusions. For transfusion-dependent patients with lower-risk MDS without chromosome 5q deletion [non-del(5q) MDS], there are limited effective treatments...
January 2017: Leukemia Research
https://www.readbyqxmd.com/read/27661264/protein-based-therapeutic-for-anemia-caused-by-dyserythropoiesis
#13
Jean-Benoît Arlet, Flavia Guillem, Mathilde Lamarque, Michael Dussiot, Thiago Maciel, Ivan Moura, Olivier Hermine, Geneviève Courtois
Major advances have been recently made in understanding the molecular determinants of dyserythropoiesis, particularly due to recent works in β-thalassemia. The purpose of this review is devoted to underline the role of some proteins recently evidenced in the field, that may be new alternative therapeutic targets in the near future to alleviate different types of anemia. Areas covered: This review covers the contemporary aspects of some proteins involved in various types of dyserythropoiesis, including the transcriptional factor GATA-1 and its protective chaperone HSP70, but also cytokines of the transforming growth factor beta (TFG-β) family, TGF-β1 and GDF-11, and hormones as erythroferrone...
October 6, 2016: Expert Review of Proteomics
https://www.readbyqxmd.com/read/27649383/testing-for-the-erythropoiesis-stimulating-agent-sotatercept-ace-011-actriia-fc-in-serum-by-means-of-western-blotting-and-lc-hrms
#14
Katja Walpurgis, Andreas Thomas, Matthias Vogel, Christian Reichel, Hans Geyer, Wilhelm Schänzer, Mario Thevis
Sotatercept (formerly ACE-011) is a glycosylated, dimeric fusion protein composed of the extracellular domain of the human activin receptor type IIA (ActRIIA) and the Fc region of human IgG1. The protein-based drug candidate acts as a ligand trap which competitively binds to activin A and other members of the transforming growth factor beta superfamily, thus blocking signalling through ActRIIA. Since the inhibition of activin A was found to significantly increase bone formation and quality, Sotatercept was originally developed for the treatment of diseases involving bone loss...
November 2016: Drug Testing and Analysis
https://www.readbyqxmd.com/read/27122198/investigational-therapies-for-renal-disease-induced-anemia
#15
REVIEW
Holger Schmid, Wolfgang Jelkmann
INTRODUCTION: The main pillars for the treatment of chronic kidney disease (CKD) associated anemia are peptidic erythropoiesis stimulating agents (ESAs) and iron preparations. Both approaches benefit from long-term efficacy and safety data but are surrounded by clinical and economic concerns, driving the search for novel anti-anemic drugs. AREAS COVERED: By answering pivotal questions, the authors describe the recent developments of next generation ESAs, introduce cutting-edge iron formulations and focus on investigational approaches that interact with pathways involved in erythropoietin (Epo) synthesis and myeloid hematopoiesis...
August 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/26842585/emerging-drugs-affecting-skeletal-muscle-function-and-mitochondrial-biogenesis-potential-implications-for-sports-drug-testing-programs
#16
Mario Thevis, Wilhelm Schänzer
RATIONALE: A plethora of compounds potentially leading to drug candidates that affect skeletal muscle function and, more specifically, mitochondrial biogenesis, has been under (pre)clinical investigation for rare as well as more common diseases. Some of these compounds could be the object of misuse by athletes aiming at artificial and/or illicit and drug-facilitated performance enhancement, necessitating preventive and proactive anti-doping measures. METHODS: Early warnings and the continuous retrieval and dissemination of information are crucial for sports drug testing laboratories as well as anti-doping authorities, as they assist in preparation of efficient doping control analytical strategies for potential future threats arising from new therapeutic developments...
March 15, 2016: Rapid Communications in Mass Spectrometry: RCM
https://www.readbyqxmd.com/read/26370220/sotatercept-ace-011-for-the-treatment-of-chemotherapy-induced-anemia-in-patients-with-metastatic-breast-cancer-or-advanced-or-metastatic-solid-tumors-treated-with-platinum-based-chemotherapeutic-regimens-results-from-two-phase-2-studies
#17
RANDOMIZED CONTROLLED TRIAL
Haralambos Raftopoulos, Abderrahmane Laadem, Paul J Hesketh, Jerome Goldschmidt, Nashat Gabrail, Cynthia Osborne, Muhammad Ali, Matthew L Sherman, Ding Wang, John A Glaspy, Marie Puccio-Pick, Jun Zou, Jeffrey Crawford
PURPOSE: Sotatercept may represent a novel approach to the treatment of chemotherapy-induced anemia (CIA). We report the results from two phase 2 randomized studies examining the use of sotatercept for the treatment of CIA in patients with metastatic cancer. METHODS: In study A011-08, patients with metastatic breast cancer were randomized to 2:2:2:1 to receive sotatercept 0.1, 0.3, or 0.5 mg/kg, or placebo, respectively, every 28 days. In study ACE-011-NSCL-001, patients with solid tumors treated with platinum-based chemotherapy received sotatercept 15 or 30 mg every 42 days...
April 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/26109203/rap-011-improves-erythropoiesis-in-zebrafish-model-of-diamond-blackfan-anemia-through-antagonizing-lefty1
#18
Jason Ear, Haigen Huang, Tianna Wilson, Zahra Tehrani, Anne Lindgren, Victoria Sung, Abderrahmane Laadem, Thomas O Daniel, Rajesh Chopra, Shuo Lin
Diamond-Blackfan Anemia (DBA) is a bone marrow failure disorder characterized by low red blood cell count. Mutations in ribosomal protein genes have been identified in approximately half of all DBA cases. Corticosteriod therapy and bone marrow transplantation are common treatment options for patients; however, significant risks and complications are associated with these treatment options. Therefore, novel therapeutic approaches are needed for treating DBA. Sotatercept (ACE-011, and its murine ortholog RAP-011) acts as an activin receptor type IIA ligand trap, increasing hemoglobin and hematocrit in pharmacologic models, in healthy volunteers, and in patients with β-thalassemia, by expanding late-stage erythroblasts through a mechanism distinct from erythropoietin...
August 13, 2015: Blood
https://www.readbyqxmd.com/read/25757219/role-of-bone-anabolic-agents-in-the-treatment-of-breast-cancer-bone-metastases
#19
REVIEW
Attaya Suvannasankha, John M Chirgwin
Skeletal metastases are an incurable complication afflicting the majority of patients who die from advanced breast cancer. They are most often osteolytic, characterized by net bone destruction and suppressed new bone formation. Life expectancy from first diagnosis of breast cancer bone metastases is several years, during which time skeletal-related events - including pain, fracture, hypercalcemia, and spinal cord compression - significantly degrade quality of life. The bone marrow niche can also confer hormonal and chemo-resistance...
2014: Breast Cancer Research: BCR
https://www.readbyqxmd.com/read/25486662/-beta-thalassemias-molecular-epidemiological-diagnostical-and-clinical-aspects
#20
REVIEW
Philippe Joly, Corinne Pondarre, Catherine Badens
Beta-thalassemia is one of most common autosomal recessive disorders worldwide. In France, 5 to 10 new major or intermedia forms are diagnosed annually and the global prevalence is about 500 cases. Since 20 years and thanks to the generalization of iron chelator treatments, the life expectancy has dramatically increased. Nearly 90% of the β-thalassemic alleles are point mutations easily identified by Sanger sequencing or dedicated methods. The remaining 10% are deletions detectable by MLPA or CGH Array. The alpha-globin genotype is also essential in the exploration of beta-thalassemia because an alpha-thalassemia improves the clinical state whereas an alpha triplication worsens it...
November 2014: Annales de Biologie Clinique
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