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Expert Opinion on Biological Therapy

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https://www.readbyqxmd.com/read/28812389/evolocumab-for-the-treatment-of-hypercholesterolemia
#1
Brian Tomlinson, Miao Hu, Yuzhen Zhang, Paul Chan, Zhong-Min Liu
Evolocumab is a fully human monoclonal immunoglobulin G2 directed against human proprotein convertase subtilisin/kexin type 9 (PCSK9). It is administered by subcutaneous injection every 2 weeks or once monthly. Area covered: Herein, the authors discuss the rationale for inhibiting PCSK9 and describe the pharmacodynamics, pharmacokinetics and clinical trials with evolocumab. Evolocumab reduces low density lipoprotein cholesterol (LDL-C) levels by 50 to 60% in most patients with and without background treatment with statins or other lipid lowering agents...
August 16, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28805081/bezlotoxumab-for-the-prevention-of-clostridium-difficile-recurrence
#2
Antoine Couture-Cossette, Alex Carignan, Subburaj Ilangumaran, Louis Valiquette
Clostridium difficile infection is a major economic and clinical burden, due to its high frequency of recurrence. Currently recommended treatments are not efficient for prevention and may contribute to the risk of recurrent infection. In recent years, research has focused on strategies to lessen this risk. Bezlotoxumab is a monoclonal antibody that prevents recurrences of C. difficile infection through the antagonism of toxin B. Areas covered: In this review, the authors discuss the burden of C. difficile infection and its recurrences, the mechanisms underlying the recurrences, and current C...
August 13, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28796556/systemic-virotherapy-for-multiple-myeloma
#3
Stefania Oliva, Manuela Gambella, Mario Boccadoro, Sara Bringhen
The multiple myeloma (MM) treatment scenario has changed considerably over the past few years. Several novel targeted therapies are currently under consideration including oncolytic virotherapy. Areas covered: This review provides an analysis of the mechanisms of action of virotherapy, and summarizes the preclinical and clinical studies of systemic virotherapy developed for the treatment of MM. Different types of viruses have been identified, including: adenovirus, vaccinia virus, herpes simplex virus 1, myxoma virus, reovirus, measles virus, vesicular stomatitis virus and coxsackievirus A21...
August 10, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28792249/induced-neural-stem-cells-as-a-means-of-treatment-in-huntington-s-disease
#4
Kyung-Ah Choi, Sunghoi Hong
Huntington's disease (HD) is an inherited neurodegenerative disease characterized by chorea, dementia, and depression caused by progressive nerve cell degeneration, which is triggered by expanded CAG repeats in the huntingtin (Htt) gene. Currently, there is no cure for this disease, nor is there an effective medicine available to delay or improve the physical, mental, and behavioral severities caused by it. Areas covered: In this review, the authors describe the use of induced neural stem cells (iNSCs) by direct conversion technology, which offers great advantages as a therapeutic cell type to treat HD...
August 9, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28791896/biologics-that-inhibit-the-th17-pathway-and-related-cytokines-to-treat-inflammatory-disorders
#5
Anna Balato, Emanuele Scala, Nicola Balato, Giuseppina Caiazzo, Roberta Di Caprio, Giuseppe Monfrecola, Annunziata Raimondo, Serena Lembo, Fabio Ayala
Advances in the understanding of TNF-α and IL-17 synergistic functions have recently led to the concept that patients who do not respond or who respond inadequately to TNF-α inhibitors may have IL-17-driven diseases, opening up the way for a new class of therapeutic development: Th17-inhibitors. Areas covered: In this review, the authors discuss the central role that the IL-23/Th17 axis plays in the pathogenesis of several inflammatory diseases, such as psoriasis, highlighting its position as a relevant therapeutic target...
August 9, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28780894/gene-therapy-for-hypertension
#6
Ludovit Paulis, Heinrich Franke, Fedor Simko
The control of hypertension and the resulting cardiovascular events is still insufficient. Thus, the search for novel means for blood pressure (BP) reduction remains worth further clinical and research attention. The advances in vector and construct design sketch the use of gene therapy in hypertension. Areas covered: The authors have searched for studies using gene therapy in hypertension reporting BP outcomes. They have identified 63 experimental studies demonstrating feasible targeting of the classical and new renin-angiotensin-aldosterone system, β1-adrenergic receptor, NO-cGMP axis, endothelin, natriuretic peptides, kallikrein system, cytochrome P-450 hydroxylase, oncogenes, growth factors, interleukins, angiopoietin-1, adrenomedullin or Klotho in small rodents...
August 7, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28777667/challenges-and-opportunities-in-the-manufacture-and-expansion-of-cells-for-therapy
#7
Joachim H Maartens, Elena M De-Juan-Pardo, Felix M Wunner, Antonio Simula, Nicolas H Voelcker, Simon C Barry, Dietmar W Hutmacher
Laboratory-based ex vivo cell culture methods are largely manual in their manufacturing processes. This makes it extremely difficult to meet regulatory requirements for process validation, quality control and reproducibility. Cell culture concepts with a translational focus need to embrace a more automated approach where cell yields are able to meet the quantitative production demands, the correct cell lineage and phenotype is readily confirmed and reagent usage has been optimized. Areas covered: This article discusses the obstacles inherent in classical laboratory-based methods, their concomitant impact on cost-of-goods and that a technology step change is required to facilitate translation from bed-to-bedside...
August 4, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28752777/anti-egfr-monoclonal-antibody-panitumumab-for-the-treatment-of-patients-with-metastatic-colorectal-cancer-an-overview-of-current-practice-and-future-perspectives
#8
Francesca Battaglin, Vincenzo Dadduzio, Francesca Bergamo, Chiara Manai, Marta Schirripa, Sara Lonardi, Vittorina Zagonel, Fotios Loupakis
Targeted agents alone or in combination with chemotherapy are current standard of treatment for metastatic colorectal cancer (mCRC). Panitumumab is a fully human monoclonal antibody which inhibits the epidermal growth factor receptor (EGFR). It is currently approved in combination with chemotherapy in first- and second-line and as a monotherapy in chemorefractory patients. RAS gene mutations confer resistance to anti-EGFR agents; thus, panitumumab is restricted to the treatment of RAS wild-type (WT) tumors...
July 28, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28737430/nivolumab-for-the-treatment-of-bladder-cancer
#9
Oliver W Hakenberg
The checkpoint inhibitor nivolumab has recently demonstrated effectiveness against metatstatic urothelial carcinoma. Nivolumab is a fully human monoclonal antibody blocking PD-1 and thereby enhancing antitumour immune mechanisms. Areas covered: In this review, the authors describe the treatment of metastatic bladder cancer with nivolumab against the background of the standard treatment with cisplatin-based chemotherapy which can prolong overall survival from 3-6 months in untreated cases to over one year. Different combinations of cisplatin-based chemotherapy can further prolong survival by only a few months...
July 24, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28707486/working-towards-dengue-as-a-vaccine-preventable-disease-challenges-and-opportunities
#10
Ambuj Shrivastava, Nagesh K Tripathi, Paban K Dash, Manmohan Parida
Dengue is an emerging viral disease that affects the human population around the globe. Recent advancements in dengue virus research have opened new avenues for the development of vaccines against dengue. The development of a vaccine against dengue is a challenging task because any of the four serotypes of dengue viruses can cause disease. The development of a dengue vaccine aims to provide balanced protection against all the serotypes. Several dengue vaccine candidates are in the developmental stages such as inactivated, live attenuated, recombinant subunit, and plasmid DNA vaccines...
July 24, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28728493/treating-breast-cancer-with-cell-based-approaches-an-overview
#11
Susanna Gallo, Dario Sangiolo, Fabrizio Carnevale Schianca, Massimo Aglietta, Filippo Montemurro
Breast cancer is the most common malignancy in women. Despite there being considerable progress in the treatment of this disease, metastatic dissemination is still considered an incurable condition at the present time, causing 500,000 deaths worldwide every year. Although most of the research efforts have been focused on pharmacological approaches, over the last three decades, the use of bone marrow and peripheral blood-derived cell therapy approaches have been attempted and developed. Areas covered: This review will briefly address cell therapy for breast cancer, including autologous stem cell transplantations for overcoming the myelosuppressive effects of high-dose chemotherapy, allogeneic stem cell transplants and adoptive immunotherapy using bone-marrow derived T-cells...
July 20, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28728489/idarucizumab-for-the-treatment-of-hemorrhage-and-dabigatran-reversal-in-patients-requiring-urgent-surgery-or-procedures
#12
Ovidiu Vornicu, Anne-Sophie Larock, Anne-Sophie Dincq, Jonathan Douxfils, Jean-Michel Dogné, François Mullier, Sarah Lessire
Idarucizumab is a specific antagonist for dabigatran etexilate (DE). The recent market authorization of idarucizumab in Europe and the USA may reassure prescribers of DE, as it can increase the safety of the emergency management of patients taking this anticoagulant. However, idarucizumab use should be limited to specific indications to avoid unnecessary risks to patients and costs to healthcare systems. Areas covered: The authors provide an overview of idarucizumab development and its pharmacokinetic and pharmacodynamic properties...
July 20, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28726562/gene-therapy-for-age-related-macular-degeneration
#13
Nicholas A Moore, Peter Bracha, Rehan M Hussain, Nuria Morral, Thomas A Ciulla
In neovascular age related macular degeneration (nAMD), gene therapy to chronically express anti-vascular endothelial growth factor (VEGF) proteins could ameliorate the treatment burden of chronic intravitreal therapy and improve limited visual outcomes associated with 'real world' undertreatment. Areas covered: In this review, the authors assess the evolution of gene therapy for AMD. Adeno-associated virus (AAV) vectors can transduce retinal pigment epithelium; one such early application was a phase I trial of AAV2-delivered pigment epithelium derived factor gene in advanced nAMD...
July 20, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28699788/allogeneic-cell-therapy-manufacturing-process-development-technologies-and-facility-design-options
#14
Saeed Abbasalizadeh, Mohammad Pakzad, Joaquim M S Cabral, Hossein Baharvand
Currently, promising outcomes from clinical trials of allogeneic cells, especially allogeneic mesenchymal stromal cells, fibroblasts, keratinocytes, and human cardiac stem cells, have encouraged research institutions, small and medium enterprises (SMEs), and big pharmaceutical companies to invest and focus on developing allogeneic cell therapy products. Commercial and large-scale production of allogeneic cell therapy products requires unique capabilities to develop technologies that generate safe and effective allogeneic cells/cell lines and their fully characterized master/working banks...
July 20, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28657381/safety-profile-of-biological-therapies-for-treating-rheumatoid-arthritis
#15
Juan D Cañete, Mª Victoria Hernández, Raimon Sanmartí
Biological agents such as tumor necrosis factor inhibitors (TNFi), abatacept, rituximab and tocilizumab have proven efficacy in RA. However, these agents are also associated with adverse events so further data is essential to detect them at the earliest stage possible. Areas covered: Herein, the authors review the safety profile of biological therapy, including TNFi and non-TNF agents including abatacept (ABA), rituximab (RTX) and tocilizumab (TCZ). The authors analyze both published articles and congress communications including clinical trials, meta-analyses, observational studies, data from registries and spontaneous clinical reports...
July 17, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28705024/medi-4736-durvalumab-in-non-small-cell-lung-cancer
#16
Arnaud Jeanson, Fabrice Barlesi
Immune checkpoint inhibitors (ICI) are now a therapeutic option for advanced non-small cell lung cancer (NSCLC) patients. ICI, such as the PD-1 inhibitors nivolumab and pembrolizumab and the PD-L1 inhibitor atezolizumab, have already been marketed for the treatment of pretreated patients with advanced NSCLC. Other notable PD-L1 inhibitors under development include avelumab and durvalumab. Areas covered: This article reviews literature on durvalumab development, from the preclinical data to the results of phase III clinical trials, whether published or presented at international scientific conferences...
July 13, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28699787/erratum
#17
(no author information available yet)
No abstract text is available yet for this article.
July 12, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28695745/treating-autoimmune-disorders-with-venom-derived-peptides
#18
Bingzheng Shen, Zhijian Cao, Wenxin Li, Jean-Marc Sabatier, Yingliang Wu
The effective treatment of autoimmune diseases remains a challenge. Voltage-gated potassium Kv1.3 channels, which are expressed in lymphocytes, are a new therapeutic target for treating autoimmune disease. Consequently, Kv1.3 channel-inhibiting venom-derived peptides are a prospective resource for new drug discovery and clinical application. Area covered: Preclinical and clinical studies have produced a wealth of information on Kv1.3 channel-inhibiting venom-derived peptides, especially from venomous scorpions and sea anemones...
July 11, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28695744/genome-editing-the-breakthrough-technology-for-inherited-retinal-disease
#19
Andrew J Smith, Stephen P Carter, Breandán N Kennedy
Genetic alterations resulting in a dysfunctional retinal pigment epithelium and/or degenerating photoreceptors cause impaired vision. These juxtaposed cells in the retina of the posterior eye are crucial for the visual cycle or phototransduction. Deficits in these biochemical processes perturb neural processing of images capturing the external environment. Notably, there is a distinct lack of clinically approved pharmacological, cell- or gene-based therapies for inherited retinal disease. Gene editing technologies are rapidly advancing as a realistic therapeutic option...
July 11, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28691538/olaratumab-for-soft-tissue-sarcoma
#20
Diego Teyssonneau, Antoine Italiano
Soft tissue sarcomas (STS) are rare malignant tumors. Unfortunately, the first-line doxorubicin-based treatment has not been improved since the 1970s. Platelet-derived growth factor (PDGF) receptor alpha (PDGFR-α) and its ligands are co-expressed in many types of cancer, including sarcomas. They are involved in stimulating growth and regulating stromal-derived fibroblasts and angiogenesis. PDGFR-α and its ligand may play an important role in tumorigenesis and be a potential target in the treatment of sarcomas...
July 10, 2017: Expert Opinion on Biological Therapy
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