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Shinji Hatakeyama, Serge Summermatter, Marie Jourdain, Stefan Melly, Giulia C Minetti, Estelle Lach-Trifilieff
BACKGROUND: Cachexia affects the majority of patients with advanced cancer and is associated with reduced treatment tolerance, response to therapy, quality of life, and life expectancy. Cachectic patients with advanced cancer often receive anti-cancer therapies against their specific cancer type as a standard of care, and whether specific ActRII inhibition is efficacious when combined with anti-cancer agents has not been elucidated yet. METHODS: In this study, we evaluated interactions between ActRII blockade and anti-cancer agents in CT-26 mouse colon cancer-induced cachexia model...
2016: Skeletal Muscle
Alessio Molfino, Maria Ida Amabile, Filippo Rossi Fanelli, Maurizio Muscaritoli
INTRODUCTION: Cachexia and sarcopenia are conditions phenotypically characterized by muscle loss and represent a factor of poor prognosis, increasing patients' morbidity and mortality. Cachectic and sarcopenic patients often suffer from low quality of life, presenting lower muscle strength and appetite loss, which makes research on novel treatment strategies to ameliorate clinical response including patient's symptoms, the objective of scientific interest. AREAS COVERED: This article covers recent developments in the area of cachexia and sarcopenia treatment and therapeutic interventions, targeting central nervous system involvement, key inflammatory and muscle-specific metabolic pathways...
October 2016: Expert Opinion on Biological Therapy
László B Tankó, Jörg Goldhahn, Aurore Varela, Elisabeth Lesage, Susan Y Smith, Andrew Pilling, Simon Chivers
Bimagrumab (BYM338) is a novel fully human monoclonal antibody that exerts strong promyogenic effects on skeletal muscle by blocking activin type II receptors (ActRII). We investigated whether such blockade of ActRII by bimagrumab manifests any detrimental effect on outcomes of bone healing in a rat fibula osteotomy model. Animals (n = 150) were divided into 11 groups and received weekly treatment with either bimagrumab (10 or 100 mg/kg) or vehicle. Progression and outcomes of bone healing were assessed by lateral radiographs in vivo as well as by peripheral quantitative computed tomography (pQCT), 4-point bending test, and microscopic examination of the excised fibula at Day 29 or later...
September 2016: Calcified Tissue International
Arseny A Sokolov, Andrea O Rossetti, Patrik Michel, David Benninger, Bernard Nater, Christian Wider, Lorenz Hirt, Thierry Kuntzer, Jean-François Démonet, Renaud A Du Pasquier, François Vingerhoets
In 2015, cerebral stimulation becomes increasingly established in the treatment of pharmacoresistant epilepsy. Efficacy of endovascular treatment has been demonstrated for acute ischemic stroke. Deep brain stimulation at low frequency improves dysphagia and freezing of gait in Parkinson patients. Bimagrumab seems to increase muscular volume and force in patients with inclusion body myositis. In cluster-type headache, a transcutaneous vagal nerve stimulator is efficient in stopping acute attacks and also reducing their frequency...
January 13, 2016: Revue Médicale Suisse
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
Janice M Reichert
The number of novel antibody therapeutics that received first marketing approvals in 2015 met expectations, with 6 (alirocumab (Praluent®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) granted first approvals as of mid-November*. Seven novel antibody therapeutics (begelomab, brodalumab, elotuzumab, ixekizumab, necitumumab, obiltoxaximab, reslizumab) are in regulatory review, and thus a similar number, if not more, are projected to gain first approvals in 2016...
2016: MAbs
Michaël R Laurent, Vanessa Dubois, Frank Claessens, Sabine M P Verschueren, Dirk Vanderschueren, Evelien Gielen, Ferran Jardí
Bone is a biomechanical tissue shaped by forces from muscles and gravitation. Simultaneous bone and muscle decay and dysfunction (osteosarcopenia or sarco-osteoporosis) is seen in ageing, numerous clinical situations including after stroke or paralysis, in neuromuscular dystrophies, glucocorticoid excess, or in association with vitamin D, growth hormone/insulin like growth factor or sex steroid deficiency, as well as in spaceflight. Physical exercise may be beneficial in these situations, but further work is still needed to translate acceptable and effective biomechanical interventions like vibration therapy from animal models to humans...
September 5, 2016: Molecular and Cellular Endocrinology
Michael R Rose, Katherine Jones, Kevin Leong, Maggie C Walter, James Miller, Marinos C Dalakas, Ruth Brassington, Robert Griggs
BACKGROUND: Inclusion body myositis (IBM) is a late-onset inflammatory muscle disease (myopathy) associated with progressive proximal and distal limb muscle atrophy and weakness. Treatment options have attempted to target inflammatory and atrophic features of this condition (for example with immunosuppressive and immunomodulating drugs, anabolic steroids, and antioxidant treatments), although as yet there is no known effective treatment for reversing or minimising the progression of inclusion body myositis...
2015: Cochrane Database of Systematic Reviews
Janice M Reichert
The commercial pipeline of recombinant antibody therapeutics is robust and dynamic. As of early December 2014, a total of 6 such products (vedolizumab, siltuximab, ramucirumab, pembrolizumab, nivolumab, blinatumomab) were granted first marketing approvals in 2014. As discussed in this perspective on antibodies in late-stage development, the outlook for additional approvals, potentially still in 2014 and certainly in 2015, is excellent as marketing applications for 7 antibody therapeutics (secukinumab, evolocumab, mepolizumab, dinutuximab, nivolumab, blinatumomab, necitumumab) are undergoing a first regulatory review in the EU or US...
2015: MAbs
Anthony A Amato, Kumaraswamy Sivakumar, Namita Goyal, William S David, Mohammad Salajegheh, Jens Praestgaard, Estelle Lach-Trifilieff, Anne-Ulrike Trendelenburg, Didier Laurent, David J Glass, Ronenn Roubenoff, Brian S Tseng, Steven A Greenberg
OBJECTIVE: To study activin signaling and its blockade in sporadic inclusion body myositis (sIBM) through translational studies and a randomized controlled trial. METHODS: We measured transforming growth factor β signaling by SMAD2/3 phosphorylation in muscle biopsies of 50 patients with neuromuscular disease (17 with sIBM). We tested inhibition of activin receptors IIA and IIB (ActRII) in 14 patients with sIBM using one dose of bimagrumab (n = 11) or placebo (n = 3)...
December 9, 2014: Neurology
Arash H Lahouti, Anthony A Amato, Lisa Christopher-Stine
PURPOSE OF REVIEW: To examine new developments in sporadic inclusion body myositis (IBM), including updated clinical and prognostic factors, novel autoantibody associations, unique histopathologic findings, proposed new clinical diagnostic criteria, and novel therapeutic agents. RECENT FINDINGS: IBM is a slowly progressive disease, leading to wheelchair use, on average, 12-20 years after onset of symptoms; however, it does not appear to interfere with life expectancy...
November 2014: Current Opinion in Rheumatology
Adam P Lightfoot, Rachel McCormick, Gareth A Nye, Anne McArdle
Age-related loss of muscle mass and function, termed sarcopenia, is a catastrophic process, which impacts severely on quality of life of older people. The mechanisms underlying sarcopenia are unclear and the development of optimal therapeutic interventions remains elusive. Impaired regenerative capacity, attenuated ability to respond to stress, elevated reactive oxygen species production and low-grade systemic inflammation are all key contributors to sarcopenia. Pharmacological intervention using compounds such as 17AAG, SS-31 and Bimagrumab or naturally occurring polyphenols to target specific pathways show potential benefit to combat sarcopenia although further research is required, particularly to identify the mechanisms by which muscle fibres are completely lost with increasing age...
June 2014: Current Opinion in Pharmacology
Joseph D Ma, Sean F Heavey, Carolyn Revta, Eric J Roeland
INTRODUCTION: Cancer cachexia is a complex multifactorial syndrome characterized by ongoing, irreversible skeletal muscle loss, leading to progressive functional impairment. Several investigational biologics targeting key inflammatory pathways and/or the myostatin/activin type II receptor pathway are in development. AREAS COVERED: Novel therapies include ALD518, MABp1, IP-1510, OHR/AVR118, bimagrumab and REGN1033 and are discussed. For each investigational therapy, the mechanism of action, preclinical data, cachexia definition, indication and clinical data are discussed...
August 2014: Expert Opinion on Biological Therapy
Estelle Lach-Trifilieff, Giulia C Minetti, KellyAnn Sheppard, Chikwendu Ibebunjo, Jerome N Feige, Steffen Hartmann, Sophie Brachat, Helene Rivet, Claudia Koelbing, Frederic Morvan, Shinji Hatakeyama, David J Glass
The myostatin/activin type II receptor (ActRII) pathway has been identified to be critical in regulating skeletal muscle size. Several other ligands, including GDF11 and the activins, signal through this pathway, suggesting that the ActRII receptors are major regulatory nodes in the regulation of muscle mass. We have developed a novel, human anti-ActRII antibody (bimagrumab, or BYM338) to prevent binding of ligands to the receptors and thus inhibit downstream signaling. BYM338 enhances differentiation of primary human skeletal myoblasts and counteracts the inhibition of differentiation induced by myostatin or activin A...
February 2014: Molecular and Cellular Biology
Janice M Reichert
Since 2010, mAbs has documented the biopharmaceutical industry's progress in transitioning antibody therapeutics to first Phase 3 clinical studies and regulatory review, and its success at gaining first marketing approvals for antibody-based products. This installment of the "Antibodies to watch" series outlines events anticipated to occur between December 2013 and the end of 2014, including first regulatory actions on marketing applications for vedolizumab, siltuximab, and ramucirumab, as well as the Fc fusion proteins Factor IX-Fc and Factor VIII-Fc; and the submission of first marketing applications for up to five therapeutics (secukinumab, ch14...
January 1, 2014: MAbs
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