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Expert Opinion on Biological Therapy

Asif Noor, Leonard R Krilov
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection in infants and elderly and to date, there is no safe or effective vaccine against RSV. Areas Covered: This review provides a roadmap to RSV vaccine development. It is a journey spanning over more than half a century from the initial disappointment with inactivated formalin vaccine to the current advancements in vaccine technology. We highlight the important aspects of RSV structural biology and protective immune response...
November 14, 2018: Expert Opinion on Biological Therapy
Cláudia R Marques, Ana Marote, Bárbara Mendes-Pinheiro, Fábio G Teixeira, António J Salgado
The available therapeutic strategies for Parkinson's disease (PD) rely only on the amelioration of the symptomatology of the disease, lacking neuroprotection or neuroregeneration capacities. Therefore, the development of disease modifying strategies is extremely important for the management of PD in the long term. Areas covered: In this review, the authors provide an overview of the current therapeutic approaches for PD and the emerging use of stem cell transplantation as an alternative. Particularly, the use of the secretome from mesenchymal stem cells (MSCs), as well as some methodologies used for the modulation of their paracrine signaling will be discussed...
November 13, 2018: Expert Opinion on Biological Therapy
Michael Whitehead, Sanjeewa Wickremasinghe, Andrew Osborne, Peter Van Wijngaarden, Keith R Martin
Diabetic retinopathy (DR) is the leading cause of vision loss in the working age population of the developed world. DR encompasses a complex pathology, and one that is reflected in the variety of currently available treatments, which include laser photocoagulation, glucocorticoids, vitrectomy and agents which neutralize vascular endothelial growth factor (VEGF). Whilst these options demonstrate modest clinical benefits, none is yet to fully attenuate clinical progression or reverse damage to the retina. This has led to an interest in developing novel therapies for the condition, such as mediators of angiopoietin signaling axes, immunosuppressants, nonsteroidal anti-inflammatory drugs (NSAIDs), oxidative stress inhibitors and vitriol viscosity inhibitors...
November 8, 2018: Expert Opinion on Biological Therapy
Francesca Bonello, Mattia D'Agostino, Maria Moscvin, Chiara Cerrato, Mario Boccadoro, Francesca Gay
Multiple myeloma (MM) is a currently incurable hematologic tumor with heterogeneous clinical behavior and prognosis. During the last years, survival improved due to a better understanding of MM biology and the development of novel drugs, although it still remains unsatisfactory in many cases: new drugs and treatment strategies are needed. CD38 is uniformly expressed at high levels on MM cells and, to a lesser extent, on the surface of normal hematopoietic and non-hematopoietic cells, making this molecule an interesting target for immunotherapeutic approaches...
November 5, 2018: Expert Opinion on Biological Therapy
Luke D Rothermel, Jonathan S Zager
Melanoma treatments have evolved rapidly in the past decade and have included the use of intratumoral injections of engineered oncolytic viruses. One such oncolytic virus is talimogene laherparepvec (T-VEC), which is the first approved therapy of its kind for use in recurrent, unresectable stage IIIB-IVM1a melanoma. Additional oncolytic viruses and their uses in combination with other interventions are currently under investigation. Areas Covered: Oncolytic viruses are being evaluated as immunotherapies for a variety of advanced malignancies...
November 4, 2018: Expert Opinion on Biological Therapy
Sheila A Doggrell
The Amyloid β (Aβ) cascade hypothesis is that reducing Aβ levels in the brain will be beneficial in treatment of Alzheimer's disease. Solanezumab is a humanized analogue of a murine antibody that selectively targets the central domain of the soluble form of Aβ. In the EXPEDITION 1 and 2 Phase 3 clinical trials, solanezumab was shown to be ineffective in subjects with mild-to-moderate Alzheimer's disease, and to have no effect on brain Aβ burden. Areas covered: This evaluation considers, in conjunction, the secondary analysis of (EXPEDITION 1 and 2), which led to the EXPEDITION 3 trial of solanezumab in subjects with mild Alzheimer's disease, and the results of EXPEDITION 3...
October 30, 2018: Expert Opinion on Biological Therapy
Ziena Abdulrahman, Kim E Kortekaas, Peggy J De Vos Van Steenwijk, Sjoerd H Van Der Burg, Mariette Ie Van Poelgeest
Vulvar squamous cell carcinoma (VSCC) develops via two different pathways: TP53 mutations in a background of lichen sclerosus or a persistent infection with high-risk human papilloma virus (HPV). The latter group of tumor responds better to treatment than the non-virally induced VSCC. This may be explained by a difference in the tumor immune microenvironment (TME). Areas covered: This review summarizes literature on TME of VSCC and its precursors, and extrapolates this to foster the development of new therapeutic strategies...
October 29, 2018: Expert Opinion on Biological Therapy
Mark A Samaan, Zehra Arkir, Tariq Ahmad, Peter M Irving
BACKGROUND: We aimed to understand the way in which therapeutic drug monitoring (TDM) is used, understood and interpreted for anti-TNF agents in IBD. RESEARCH DESIGN AND METHODS: We designed an 18-question survey that included 5 TDM-based clinical scenarios, for which the 'most appropriate' responses were based on the BRIDGe groups 'Anti-TNF Optimizer'. This resource combines TDM evidence with expert consensus. RESULTS: We received 110 complete responses: 50 (45%) consultants, 30 (27%) trainees, 25 (23%) IBD nurse specialists and 5 (5%) gastroenterology pharmacists...
October 24, 2018: Expert Opinion on Biological Therapy
Nicola E Natsis, Alice B Gottlieb
Psoriasis and psoriatic arthritis are common diseases with significant physical and emotional burden. Several biologics are FDA-approved to treat psoriasis and psoriatic arthritis, though some patients remain refractory to, or have lost response to, therapy and/or cannot tolerate the associated risks and side effects. Bimekizumab is a new biologic that inhibits both IL-17A and IL-17F. It is currently in phase III clinical trials. To date, phase II studies show promise in its ability to rapidly resolve symptoms while remaining safe and well-tolerated...
October 18, 2018: Expert Opinion on Biological Therapy
Paurvi Shinde, Vinita Bharat, Annabelle Rodriguez-Oquendo, Beiyan Zhou, Anthony T Vella
Due to the ability of pathogen-associated molecular patters and tumor necrosis factor receptor (TNFR) family costimulatory agonists to boost T cell responses, studies have combined Toll-like receptor (TLR) ligands with TNFR family costimulatory receptor agonists to induce impressive and long-lasting T cell responses. Although some studies have determined how these combinatorial vaccines promote enhanced T cell responses, much remains unknown about the mechanism used by these combinations to promote synergistic T cell responses - especially in settings of infectious diseases or cancer...
September 12, 2018: Expert Opinion on Biological Therapy
Zulema Romero, Mark DeWitt, Mark C Walters
Sickle cell anemia (SCA) is a hereditary blood disease caused by a single-gene mutation that affects millions of individuals world-wide. In this review, we focus on techniques to treat SCA by ex vivo genetic manipulation of hematopoietic stem/progenitor cells (HSPC), emphasizing replacement gene therapy and gene editing. Areas covered: Viral transduction of an anti-sickling β-like globin gene has been tested in pre-clinical and early-phase clinical studies, and shows promising preliminary results. Targeted editing of endogenous genes by site-directed nucleases has been developed more recently, and several approaches also are nearing clinical translation...
November 2018: Expert Opinion on Biological Therapy
Serap Gur, Asim B Abdel-Mageed, Suresh C Sikka, Wayne J G Hellstrom
Stem cell (SC) application is a promising area of research in regenerative medicine, with the potential to treat, prevent, and cure disease. In recent years, the number of studies focusing on SCs for the treatment of erectile dysfunction (ED) and other sexual dysfunctions has increased significantly. Areas covered: This review includes critical ED targets and preclinical studies, including the use of SCs and animal models in diabetes, aging, cavernous nerve injury, and Peyronie's disease. A literature search was performed on PubMed for English articles...
November 2018: Expert Opinion on Biological Therapy
Xavier Thomas, Etienne Paubelle
Cellular immunotherapy with autologous or allogeneic T cells, genetically engineered to express chimeric antigen receptors (CARs) or T-cell receptors, in order to redirect their cytotoxic specificity toward malignant cells, is emerging as a promising new treatment modality. The most advanced approach in clinical development is the use of anti-CD19 CAR T-cells for the treatment of CD19+ B-cell malignancies, including acute lymphocytic leukemia (ALL). Areas covered: Recently, the Food and Drug Administration (FDA) approved the first anti-CD19 CAR T-cell product, tisagenlecleucel, for the treatment of pediatric and young adult patients with relapsed/refractory ALL...
November 2018: Expert Opinion on Biological Therapy
Jingbo Hu, Min Wang, Yufen Zhao
The global incidence of diabetes mellitus is increasing, with a concomitant rise in individual and overall treatment costs. The development of biosimilars contributes to the facilitation of greater access to treatment. SAR342434 is a biosimilar follow-on of insulin lispro, a key therapeutic for the treatment of diabetes mellitus, and it is currently under phase III clinical trials. Areas covered: In this review we discuss the recent updates on clinical data obtained from phase III trials to compare the equivalence and similarity of SAR342434 to insulin lispro, including pharmacokinetics (PKs), pharmacodynamics, clinical efficacy, safety and immunogenicity...
November 2018: Expert Opinion on Biological Therapy
Jianyu Zou, Bo Bai, Yongchang Yao
Cartilage tissue engineering has rapidly developed in recent decades, exhibiting promising potential to regenerate and repair cartilage. However, the origin of a large amount of a suitable seed cell source is the major bottleneck for the further clinical application of cartilage tissue engineering. The use of a monoculture of passaged chondrocytes or mesenchymal stem cells results in undesired outcomes, such as fibrocartilage formation and hypertrophy. In the last two decades, co-cultures of chondrocytes and a variety of mesenchymal stem cells have been intensively investigated in vitro and in vivo, shedding light on the perspective of co-culture in cartilage tissue engineering...
November 2018: Expert Opinion on Biological Therapy
Adam M Swartz, Steven H Shen, Miguel A Salgado, Kendra L Congdon, Luis Sanchez-Perez
Conventional therapies for glioblastoma  (GBM) typically fail to provide lasting antitumor benefits, owing to their inability to specifically eliminate all malignant cells. Cancer vaccines are currently being evaluated as a means to direct the adaptive immune system to target residual GBM cells that remain following standard-of-care treatment. Areas covered: In this review, we provide an overview of the more noteworthy cancer vaccines that are under investigation for the treatment of GBM, as well as potential future directions that may enhance GBM-vaccine effectiveness...
November 2018: Expert Opinion on Biological Therapy
Anita Bálint, Mariann Rutka, Martin Kolar, Martin Bortlik, Dana Duricova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Milan Lukas, Zoltán Szepes, Ferenc Nagy, Károly Palatka, Szilvia Lovas, Zsuzsanna Végh, Zsuzsanna Kürti, Ágnes Csontos, Pál Miheller, Tibor Nyári, Renáta Bor, Ágnes Milassin, Anna Fábián, Kata Szántó, Péter L Lakatos, Tamás Molnár, Klaudia Farkas
BACKGROUND: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC. METHODS: CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study...
November 2018: Expert Opinion on Biological Therapy
Theocharis Koufakis, Spyridon N Karras, Pantelis Zebekakis, Ramzi Ajjan, Kalliopi Kotsa
INTRODUCTION: Early short-term insulin treatment (STIT), defined as insulin administration shortly after diabetes diagnosis for only a brief period of time, is an alternative concept, aiming to entirely revise the perspective of type 2 diabetes (T2DM) management. Areas covered: The present review intends to summarize what is already known regarding early STIT in T2DM and highlight questions and dilemmas from the clinician's point of view, with a discourse on future research agenda. Expert opinion: STIT has the potential to modify the natural history of T2DM, resulting in improved drug-free remission rates by favorably affecting the underlying pathophysiology of the disease...
November 2018: Expert Opinion on Biological Therapy
Carl Britto, Christina Dold, Arturo Reyes-Sandoval, Christine S Rollier
The emergence of the Zika virus (ZIKV) in Latin America in 2015-2016 led to an expeditious search for vaccine candidates, with a DNA-based candidate having progressed to Phase II. However, several features of ZIKV infection and epidemiology are not understood, which may be key to maximizing efficacy and ensuring safety of ZIKV vaccines. Areas covered: Conceivable problems related to vaccine development and policy include: (1) paucity of diagnostics to satisfactorily discriminate between past ZIKV and dengue virus (DENV) exposure; (2) insufficient knowledge of the mechanisms of ZIKV neurovirulence, amongst other unknowns in the biology of this infection, is particularly relevant from a vaccine safety perspective; and (3) the potential for disease enhancement, as observed with DENV infection and vaccine...
November 2018: Expert Opinion on Biological Therapy
Priscilla de Graaff, Coen Govers, Harry J Wichers, Reno Debets
Adoptive T-cell treatments of solid cancers have evolved into a robust therapy with objective response rates surpassing those of standardized treatments. Unfortunately, only a limited fraction of patients shows durable responses, which is considered to be due to a T cell-suppressive tumor microenvironment (TME). Here we argue that naturally occurring β-glucans can enable reversion of such T cell suppression by engaging innate immune cells and enhancing numbers and function of lymphocyte effectors. Areas covered: This review summarizes timely reports with respect to absorption, trafficking and immune stimulatory effects of β-glucans, particularly in relation to innate immune cells...
October 2018: Expert Opinion on Biological Therapy
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