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Expert Opinion on Investigational Drugs

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https://www.readbyqxmd.com/read/28161993/eribulin-in-non-small-cell-lung-cancer-challenges-and-potential-strategies
#1
Umang Swami, Umang Shah, Sanjay Goel
Eribulin is a non-taxane, macrocyclic, synthetic, ketone analog of Halichondrin B with a microtubule inhibitory action specific towards plus ends. It is approved by United States Food and Drug Administration (USFDA) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. It is also approved as a third line therapy for patients with metastatic breast cancer who have received a prior treatment with anthracycline and taxane in either adjuvant or metastatic setting...
February 6, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28161988/therapeutic-inhibition-of-bcl-2-and-related-family-members
#2
Michelle Levy, David Claxton
BCL-2 proteins are key players in the balance of cell life and death. Their roles in the development and biology of cancer have been well established and continue to be investigated. Understanding the mechanisms by which these proteins regulate apoptosis has led to the development of small molecule targeted therapies that act to overcome the cell's ability to evade programmed cell death. Areas covered: The biology of the intrinsic apoptotic pathway is reviewed with attention to the varied roles of the anti-apoptotic members of the BCL-2 family...
February 6, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28121208/fgfr-targeted-therapeutics-for-the-treatment-of-breast-cancer
#3
Antonella De Luca, Daniela Frezzetti, Marianna Gallo, Nicola Normanno
Breast cancer is a complex disease and several molecular drivers regulate its progression. Fibroblast growth factor receptor (FGFR) signaling is frequently deregulated in many cancers, including breast cancer. Due the involvement of the FGFR/FGF axis in the pathogenesis and progression of tumors, FGFR-targeted agents might represent a potential therapeutic option for breast cancer patients. Areas covered: This review offers an overview of targeted agents against FGFRs and their clinical development in breast cancer...
February 6, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28117615/investigational-beta-2-adrenergic-agonists-for-the-treatment-of-chronic-obstructive-pulmonary-disease
#4
Mario Malerba, Alessandro Radaeli, Paolo Montuschi, Kesavan S Babu, Jaymin B Morjaria
Long-acting bronchodilators are pivotal in the therapeutic management of COPD patients with moderate-to-severe airflow obstruction. New ultra-long-acting β2-agnoists (ultra-LABAs) have been developed, some of which have been licensed for use as monotherapy and/or in combination with other bronchodilators or inhaled corticosteroids, for use in COPD patients with persistent symptoms and worsening airflow limitation. These new agents are faster in onset and have a prolonged duration of action, with a similar safety profile to the traditional twice-daily bronchodilators which may have an impact on patient concordance...
February 6, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28103158/serotonin-receptor-targeted-therapy-for-migraine-treatment-an-overview-of-drugs-in-phase-i-and-ii-clinical-development
#5
Piero Barbanti, C Aurilia, G Egeo, L Fofi, R Palmirotta
Research has focused on serotonin (5-HT) 5-HT1D and 5-HT1F receptors to develop drugs acting through non-vasoconstrictive mechanisms for treating acute migraine and those targeting 5-HT2B and 5-HT7 receptors for preventing migraine. Areas covered: This paper reviews antimigraine drugs targeting 5-HT receptors in one phase I trial (sumatriptan iontophoretic transdermal system, TDS) and five phase II clinical trials (PNU-142633, LY334370, lasmiditan, NOX-188). Expert opinion: Data from our overview on investigational drugs in phase I and II clinical trials using the 5-HT1B/1D receptor agonist (sumatriptan TDS), 5-HT1D receptor agonist (PNU-142633), 5-HT1F receptor agonists (LY334370, lasmiditan) and a combined 5-HT1B/1D receptor agonist with nNOS inhibition (NOX-188) provided encouraging data for sumatriptan TDS and lasmiditan, disappointing results for PNU-142633, and promising findings for NOX-188...
February 1, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28141955/investigational-new-drugs-for-allergic-rhinitis
#6
Peter A Ricketti, Sultan Alandijani, Chen Hsing Lin, Thomas B Casale
Allergic rhinitis (AR) is a multifactorial disease characterized by paroxysmal symptoms of sneezing, rhinorrhea, postnasal drip and nasal congestion. For over a century, subcutaneous allergen immunotherapy (SCIT) has been recognized as the most effective therapy to date that may modify the underlying disease course and provide long-term benefits for individuals refractory to pharmacotherapy. However, over the past 25 years, there has been substantial growth in developing alternative therapies to traditional SCIT...
January 31, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28140696/siltuximab-and-hematologic-malignancies-a-focus-in-non-hodgkin-lymphoma
#7
Andrea Ferrario, Michele Merli, Claudia Basilico, Margherita Maffioli, Francesco Passamonti
The role of interleukin-6 (IL-6) in tumorigenesis and in particular in haematological malignancies is crucial. On the basis of the favourable results obtained in the subset of multicentric Castleman disease (MCD), Siltuximab, a chimeric, human-murine, immunoglobulin (Ig) Gk monoclonal antibody directed against human IL-6 has been evaluated in haematological malignancies such as multiple myeloma, myelodisplastic syndromes and non Hodgkin lymphomas. Areas covered: This review discusses available data related to the role of IL-6 as a therapeutic target, the characteristics of Siltuximab in term pharmacokinetics and pharmacodynamics properties and a detailed analysis of the studies involving haematological malignancies with a peculiar focus on non Hodgkin lymphoma...
January 31, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28127997/investigational-drug-therapies-for-the-treatment-of-gastroparesis
#8
Gareth J Sanger, Pankaj Jay Pasricha
Gastroparesis is defined by nausea, vomiting, pain, early satiety and bloating, and characterized by delayed gastric emptying without obvious structural abnormalities. Metoclopramide is widely used, increasing gastric emptying and inhibiting nausea and vomiting. Other drugs are available in certain countries and some are used 'off-label' because they increase gastric emptying or inhibit emesis. However, correlation between gastroparesis symptoms and rates of gastric emptying is poor. For anti-emetic drugs, dose-ranging and Phase III trials in gastroparesis are lacking...
January 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28092725/strontium-ranelate-a-promising-disease-modifying-osteoarthritis-drug
#9
Weiyu Han, Shicai Fan, Xiaochun Bai, Changhai Ding
The articular cartilage and subchondral bone may have potential crosstalk in the development and progression of osteoarthritis (OA). Strontium ranelate (SrR) has the ability to dissociate the bone remodeling process and to change the balance between bone resorption and bone formation. Its effect on subchondral bone makes it a potential disease- modifying osteoarthritis drug (DMOAD) in the treatment of OA. The aim of the current review is to summarize up-to-date pharmacological and clinical data of SrR for OA treatment...
January 25, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28064554/evaluating-bempedoic-acid-for-the-treatment-of-hyperlipidaemia
#10
Peter Penson, Mary McGowan, Maciej Banach
Despite the effectiveness of statins in the treatment of lipid disorders, residual risk still exists, and hitherto studies where additional drugs were added to statin therapy have been mainly negative or the outcomes were very modest. Therefore there is still a need for new and effective oral agents in the combination therapy of lipid disorders. Areas covered: The review covers the current state of knowledge on the mechanism of action of bempedoic acid (ETC-1002) and results from recent clinical studies. Expert opinion: ETC-1002 is a novel oral lipid-lowering therapy...
January 17, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28085503/dupilumab-for-the-treatment-of-asthma
#11
Giuseppe Santini, Nadia Mores, Mario Malerba, Chiara Mondino, Roberta Anzivino, Giuseppe Macis, Paolo Montuschi
Introduction Dupilumab (REGN668/SAR231893), produced by a collaboration between Regeneron and Sanofi, is a monoclonal antibody currently in phase III for moderate-to-severe asthma. Dupilumab is directed against the α-subunit of the interleukin (IL)-4 receptor and blocks the IL-4 and IL-13 signal transduction. Areas Covered Pathophysiological role of IL-4 and IL-13 in asthma; mechanism of action of dupilumab; pharmacology of IL-4 receptor; phase I and phase II studies with dupilumab; regulatory affair. Expert opinion Patients with severe asthma who are not sufficiently controlled with standard-of-care represent the target asthma population for dupilumab...
January 13, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28076702/lasmiditan-for-the-treatment-of-migraine
#12
Matilde Capi, Fernando de Andrés, Luana Lionetto, Giovanna Gentile, Fabiola Cipolla, Marina Borro, Paolo Martelletti, Martina Curto
Migraine is one of the most common diseases in the world, with high economical and subjective burden. Migraine acute therapy is nowadays based on specific and non-specific drugs but up to 40% of episodic migraineurs still have unmet treatment needs and over 35% do not benefit from triptans administration. Serotonin-1F receptors have been identified in trigeminal system and became an ideal target for anti-migraine drug development as potential trigeminal neural inhibitors. Lasmiditan, a novel serotonin1F receptor agonist, showed specific affinity in vitro for the receptor with any vasoconstrictive action and inhibited markers associated with electrical stimulation of trigeminal ganglion in migraine animal models...
January 11, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28056562/the-latest-prospects-of-investigational-drugs-for-head-and-neck-cancer
#13
Olgun Elicin, Mahmut Ozsahin
No abstract text is available yet for this article.
January 10, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28054500/erratum
#14
(no author information available yet)
No abstract text is available yet for this article.
January 5, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28043173/glucocorticoid-targeted-therapies-for-the-treatment-of-rheumatoid-arthritis
#15
Cindy Strehl, Marlies C van der Goes, Johannes W J Bijlsma, Johannes W G Jacobs, Frank Buttgereit
The beneficial effects of glucocorticoids are highly regarded in the treatment of inflammatory diseases. In rheumatoid arthritis, these drugs are widely used because they effectively reduce signs and symptoms of the disease, and exert disease-modifying effects. However, both patients and physicians frequently associate glucocorticoids with a variety of adverse effects which hamper adherence. Due to this ambivalent nature of these drugs, several new glucocorticoids or glucocorticoid receptor ligands are being developed, aiming at improving their benefit-risk balance...
January 3, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28043164/current-treatment-options-and-investigational-drugs-for-waldenstrom-s-macroglobulinemia
#16
Maria Gavriatopoulou, Evangelos Terpos, Efstathios Kastritis, Meletios A Dimopoulos
Waldenström's Macroglobulinemia (WM) is a rare, indolent, incurable, low-grade B-cell lymphoplasmacytic neoplasm. This review article provides a modern clinical perspective of the individualized management of patients with symptomatic WM, in the context of the updated treatment guidelines and the currently available trial data. Areas covered: Rituximab-based regimens (such as the dexamethasone, rituximab and cyclophosphamide combination, DRC) are the most widely used in the management of both newly diagnosed and relapsed/refractory patients with WM...
January 3, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28042732/the-potential-utility-of-tildrakizumab-an-interleukin-23-inhibitor-for-the-treatment-of-psoriasis
#17
Zenas Z N Yiu, Richard B Warren
The approved biologic therapies are effective for the treatment of psoriasis, but have limitations. Tildrakizumab has a different mechanism of action and is a humanized immunoglobulin G1κ that binds to the p19 subunit of IL23. Areas covered: Phase I, II and III clinical trials investigated the pharmacokinetics, efficacy, safety and immunogenicity of tildrakizumab for patients with psoriasis. The mean half-life of tildrakizumab is between 20.2 to 28.2 days. Tildrakizumab achieved a PASI 75 of 66% and 74% at week 16 for the doses of 100 mg and 200 mg respectively in a phase IIb randomised clinical trial (RCT), and PASI 75 of 61%/64% and 62%/66% at week 12 for 100 mg and 200 mg respectively in two phase III RCTs...
January 1, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28042706/do-cdk4-6-inhibitors-have-potential-as-targeted-therapeutics-for-squamous-cell-cancers
#18
Nene N Kalu, Faye M Johnson
Introduction Dysregulation of cell cycle progression has an established link to neoplasia and cancer progression. Components of the cyclin D-CDK4/6-INK4-Rb pathway are frequently altered in squamous cell carcinomas (SCCs) by diverse mechanisms, including viral oncogene-induced degradation, mutation, deletion, and amplification. Activation of the CDK4/6 pathway may predict response to CDK4/6 inhibitors and provide clinical biomarkers. Recently, the CDK4/6 inhibitor palbociclib showed clinical efficacy in combination with cetuximab in HNSCC patients...
January 1, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28001095/antileukemic-effects-of-midostaurin-in-acute-myeloid-leukemia-the-possible-importance-of-multikinase-inhibition-in-leukemic-as-well-as-nonleukemic-stromal-cells
#19
Tor Henrik Tvedt, Ina Nepstad, Øystein Bruserud
Midostaurin is a multikinase inhibitor that inhibits receptor tyrosine kinases (Flt3, CD117/c-kit, platelet-derived growth factor receptor, vascular endothelial growth factor receptor 2) as well as non-receptor tyrosine kinases (Frg, Src, Syk, Protein kinase C). Combination of midostaurin with conventional intensive chemotherapy followed by one year maintenance monotherapy was recently reported to improve the survival of acute myeloid leukemia (AML) patients with Flt3 mutations. Areas covered: Relevant publications were identified through literature searches in the PubMed database...
December 28, 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/27998189/letermovir-for-the-management-of-cytomegalovirus-infection
#20
Lyndsey J Bowman, Jennifer Iuppa Melaragno, Daniel C Brennan
Cytomegalovirus (CMV) is a major cause of morbidity and mortality in immunocompromised patients. Available antivirals are fraught with adverse effects and risk for the development of CMV resistance. Letermovir is a novel antiviral in the late stages of drug development for the treatment and prevention of CMV. Areas covered: A MEDLINE search of the MeSH terms 'letermovir,' 'cytomegalovirus,' 'hematopoietic stem cell transplant,' and 'solid organ transplant,' was last conducted on 15 August 2016. Articles were selected on the basis of their contribution to current knowledge about letermovir...
December 28, 2016: Expert Opinion on Investigational Drugs
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