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Expert Opinion on Investigational Drugs

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https://www.readbyqxmd.com/read/28730878/investigational-drugs-in-development-for-hepatitis-d
#1
Mario Rizzetto
Treatment of chronic hepatitis D still relies on Interferon. To improve efficacy, new therapeutic strategies are in development which aim to deprive the Hepatitis D Virus (HDV) of functions of the Hepatitis B Virus and of the host required for its life-cycle. Areas covered: The therapeutic options are; 1) The inhibition of the farnesylation of the large HD-protein permissive of virion assembly with Lonafarnib, 2) The blocking of HBsAg entry into cells with Myrcludex B via the inhibition of the Sodium Taurocholate Cotransporting Receptor, to prevent the spreading of HDV to uninfected hepatocytes, 3) The reduction of subviral HBsAg particles by REP 2139, leading to diminished virion morphogenesis ...
July 21, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28726523/investigational-therapies-for-the-treatment-of-narcolepsy
#2
Stefano de Biase, Annacarmen Nilo, Gian Luigi Gigli, Mariarosaria Valente
Narcolepsy is a chronic sleep disorder characterized by a pentad of excessive daytime sleepiness (EDS), cataplexy, sleep paralysis, hypnagogic/hypnopompic hallucinations, and disturbed nocturnal sleep. While non-pharmacological treatments are sometimes helpful, more than 90% of narcoleptic patients require a pharmacological treatment. Areas covered: The present review is based on an extensive Internet and PubMed search from 1994 to 2017. It is focused on drugs currently in development for the treatment of narcolepsy...
July 20, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28721753/nintedanib-in-ovarian-cancer
#3
Saira Khalique, Susana Banerjee
Advanced ovarian cancer remains an unmet clinical need. Angiogenesis is considered a therapeutic target in ovarian cancer, with bevacizumab, a monoclonal antibody against VEGF, being the first drug to show a progression-free survival benefit. Nintedanib is an oral tyrosine kinase inhibitor targeting VEGF receptor 1-3, FGFR 1-3 and PDGFR α and β, which has entered phase III trial development in ovarian cancer. Areas covered: This article reviews the preclinical and clinical efficacy of nintedanib in ovarian cancer, its pharmacokinetic and pharmacodynamics profile, safety issues, together with an overview of clinical trials carried out so far...
July 19, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28718331/entinostat-for-the-treatment-of-breast-cancer
#4
Dario Trapani, Angela Esposito, Carmen Criscitiello, Luca Mazzarella, Marzia Locatelli, Ida Minchella, Saverio Minucci, Giuseppe Curigliano
Breast cancer accounts for 29% of malignant tumors. It is an heterogenous disease covering a spectrum of different molecular subtypes. Epigenetic aberrations may affect gene expression through DNA and histone proteins modifications thus promoting tumor progression and resistance to anti- tumor treatment. Area covered: This article explores the potential role of entinostat in the treatment of breast cancer. The clinical trials evaluating entinostat are discussed, highlighting preclinical data and early-phase clinical studies results...
July 18, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28714740/do-stat3-inhibitors-have-potential-in-the-future-for-cancer-therapy
#5
Andrea L A Wong, Jayshree L Hirpara, Shazib Pervaiz, Jie-Qing Eu, Gautam Sethi, Boon-Cher Goh
No abstract text is available yet for this article.
July 17, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28707483/investigational-drugs-in-development-for-focal-segmental-glomerulosclerosis
#6
Howard Trachtman
Focal segmental glomerulosclerosis is an important cause of end stage kidney disease and is a paradigm for the study of glomerular scarring. There are no FDA approved treatments for this condition. Current therapies, assessed based on reduction in proteinuria, are generally effective in a subset of patients which suggests that FSGS is a heterogeneous group of glomerular disorders or podocytopathies that converge on a common histopathological phenotype. Areas covered: We searched for investigational drugs agents that target different pathophysiological pathways using the key words 'FSGS' and 'podocyte' in American and European clinical trial registers (clinicaltrials...
July 14, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28689433/experimental-and-early-investigational-drugs-for-androgenetic-alopecia
#7
Hongwei Guo, Wendi Victor Gao, Hiromi Endo, Kevin John McElwee
Treatments for androgenetic alopecia constitute a multi-billion-dollar industry, however, currently available therapeutic options have variable efficacy. Consequently, in recent years small biotechnology companies and academic research laboratories have begun to investigate new or improved treatment methods. Research and development approaches include improved formulations and modes of application for current drugs, new drug development, development of cell-based treatments, and medical devices for modulation of hair growth...
July 12, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28691539/investigational-antiarrhythmic-agents-promising-drugs-in-early-clinical-development
#8
Jordi Heijman, Shokoufeh Ghezelbash, Dobromir Dobrev
Although there have been important technological advances for the treatment of cardiac arrhythmias (e.g., catheter ablation technology), antiarrhythmic drugs (AADs) remain the cornerstone therapy for the majority of patients with arrhythmias. Most of the currently available AADs were coincidental findings and did not result from a systematic development process based on known arrhythmogenic mechanisms and specific targets. During the last 20 years, our understanding of cardiac electrophysiology and fundamental arrhythmia mechanisms has increased significantly, resulting in the identification of new potential targets for mechanism-based antiarrhythmic therapy...
July 10, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28661188/bruton-s-tyrosine-kinase-inhibitors-in-b-cell-lymphoma-current-experience-and-future-perspectives
#9
T Seiler, M Dreyling
The Bruton tyrosine kinase (BTK) is a central hub in the B cell receptor (BCR) pathway and strongly influences B cell maturation, differentiation and proliferation. Not surprisingly, BTK plays an essential role in the pathogenesis of various B cell lymphomas. Inhibitors of BTK have broadened our therapeutic options in several B cell lymphomas and already are an integral element in the treatment of Mantle Cell Lymphoma (MCL), chronic lymphocytic leukemia (CLL) and Waldenström's marcoglobulinemia. Several second generation BTK inhibitors are in clinical development and might further improve tolerability and efficacy of therapy in advanced stage CLL and MCL...
July 10, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28685626/lurasidone-for-the-treatment-of-irritability-and-anger-in-autism-spectrum-disorders
#10
Lynn McClellan, Kelli C Dominick, Ernest V Pedapati, Logan K Wink, Craig A Erickson
Autism Spectrum Disorder (ASD) is a heterogeneous neurodevelopmental disorder characterized by deficits in social interaction and communication as well as restricted patterns of behaviors and interests. Irritability marked by tantrums, self-injury and aggression occurs frequently in youth with ASD, causing significant parent and caregiver distress. Atypical antipsychotics have been the most studied drug class targeting irritability in ASD. Risperidone and aripiprazole are Food and Drug Administration (FDA)-approved atypical antipsychotics for treatment of irritability in youth with ASD...
July 7, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28679291/promising-investigational-drug-candidates-in-phase-i-and-phase-ii-clinical-trials-for-mesothelioma
#11
Alice Guazzelli, Emyr Bakker, Kun Tian, Constantinos Demonacos, Marija Krstic-Demonacos, Luciano Mutti
Malignant mesothelioma is a rare and lethal malignancy primarily affecting the pleura and peritoneum. Mesothelioma incidence is expected to increase worldwide and current treatments remain ineffective, leading to poor prognosis. Within this article potential targets to improve the quality of life of the patients and assessment of further avenues for research are discussed. Areas covered: This review highlights emerging therapies currently under investigation for malignant mesothelioma with a specific focus on phase I and phase II clinical trials...
July 6, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28675058/selumetinib-for-the-treatment-of-non-small-cell-lung-cancer
#12
Francesca Casaluce, Assunta Sgambato, Paolo Maione, Paola Claudia Sacco, Giuseppe Santabarbara, Cesare Gridelli
KRAS is the most frequently mutated oncogene in NSCLC, occurring in around a third of patients. However, this largest genomically defined subgroup of lung cancer patients seem to remain "undruggable", with any effective targeted therapy approved at the moment. The prognostic and predictive power and thus the clinical utility of KRAS oncogenic mutations in lung cancer are highly debated issues, not supportive of KRAS testing in clinical practice of NSCLC therapy. Areas covered: A phase II trial in KRAS-mutant NSCLC had shown significant improvements in PFS and ORR in patients treated with selumetinib plus docetaxel compared to docetaxel alone...
July 4, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28670932/alicaforsen-for-the-treatment-of-inflammatory-bowel-disease
#13
Vipul Jairath, Reena Khanna, Brian G Feagan
Introduction Intracellular adhesion molecule-1 (ICAM-1), is a transmembrane glycoprotein of the immunoglobulin family, constitutively expressed on vascular endothelial cells and upregulated in inflamed colonic tissue. Alicaforsen, a 20 base ICAM-1 anti-sense oligonucleotide and highly selective ICAM-1 inhibitor, down-regulates ICAM-1 mRNA. Areas covered We review mechanism of action, pharmacokinetics, pre-clinical, clinical and safety data of alicaforsen for the treatment of ulcerative colitis (UC), pouchitis and Crohn's disease (CD)...
July 3, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28651442/a-randomized-single-blind-phase-i-trial-invictan-1-assessing-the-bioequivalence-and-safety-of-bi-695502-a-bevacizumab-biosimilar-candidate-in-healthy-subjects
#14
Willem Hettema, Christopher Wynne, Benjamin Lang, Mario Altendorfer, Niklas Czeloth, Ragna Lohmann, Sandeep Athalye, Dorothee Schliephake
OBJECTIVES: This Phase I trial (INVICTAN(®)-1) evaluated three-way bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin(®), Genentech; EU-approved Avastin, Roche). METHODS: Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary endpoint to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early...
June 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28627277/anti-acne-drugs-in-phase-1-and-2-clinical-trials
#15
REVIEW
Christos C Zouboulis, Clio Dessinioti, Fragkiski Tsatsou, Harald P M Gollnick
Despite the impressive increase of knowledge on acne etiology accumulated during the last 20 years, few efforts have been overtaken to introduce new therapeutic regiments targeting the ideal treatment of acne. The increasing emergence of microbial resistance associated with antibiotics, teratogenicity, particularly associated with systemic isotretinoin, and the need for an adverse drug profile, which can be tolerated by the patient, make the need of new pathogenesis relevant anti-acne agents an emerging issue...
July 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28617137/drugs-currently-under-investigation-for-the-treatment-of-invasive-candidiasis
#16
REVIEW
Matthew W McCarthy, Thomas J Walsh
The widespread implementation of immunosuppressants, immunomodulators, hematopoietic stem cell transplantation and solid organ transplantation in clinical practice has led to an expanding population of patients who are at risk for invasive candidiasis, which is the most common form of fungal disease among hospitalized patients in the developed world. The emergence of drug-resistant Candida spp. has added to the morbidity associated with invasive candidiasis and novel therapeutic strategies are urgently needed...
July 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28587531/dapagliflozin-for-the-treatment-of-type-1-diabetes-mellitus
#17
REVIEW
Kalliopi Pafili, Efstratios Maltezos, Nikolaos Papanas
In 2017, the management of type 1 diabetes mellitus (T1DM) remains intriguing for the clinician, who has to balance between adequate glycemic control and untoward events related to insulin up-titration. Thus, agents that will complement insulin actions and reduce adverse effects are highly welcome. Areas covered: In this review, the authors summarize results from studies on the sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin in T1DM. Expert opinion: In T1DM, dapagliflozin is associated with significant antihyperglycemic and metabolic properties, which are achieved with reduction or stabilization of insulin dose and with a very low trend for hypoglycemia...
July 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28562105/prasugrel-hydrochloride-for-the-treatment-of-sickle-cell-disease
#18
REVIEW
Nicola Conran, David C Rees
Therapeutic options for sickle cell disease (SCD) are limited and, currently, only one drug (hydroxyurea) has FDA approval for the treatment of adult SCD. While this genetic disease is caused by hemoglobin polymerization, subsequent downstream events trigger platelet activation, vaso-occlusion and the disease's complex pathophysiology. Areas covered: The oral thienopyridine, prasugrel hydrochloride, irreversibly inhibits the P2Y12 receptors, inhibiting ADP-dependent platelet activation. We discuss recent clinical trials evaluating the pharmokinetics of prasugrel and its potential for use in SCD...
July 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28562100/developments-with-experimental-and-investigational-drugs-for-axial-spondyloarthritis
#19
REVIEW
Gaëlle Clavel, Marie-Christophe Boissier, Johanna Sigaux, Luca Semerano
Axial spondyloarthritis (AxS pA) is a chronic inflammatory disease for which, until recently, there were no valid therapeutic alternatives to TNF-α blocking agents. This unmet clinical need led to explore several therapeutic targets, from proinflammatory cytokines to intracellular signaling systems. The recent approval of Secukinumab, an anti-IL-17A monoclonal antibody, marked a new step in the evolution of AxSpA treatment. Areas covered: the authors review and discuss all the biological or synthetic agents that are currently developed or that have been tested in AxSpA...
July 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28541801/enemies-or-weapons-in-hands-investigational-anti-diabetic-drug-glibenclamide-and-cancer-risk
#20
REVIEW
Rui Gao, Tao Yang, Wei Xu
Epidemiological evidence suggests that diabetes is associated with elevated cancer risk through the actions of hyperglycemia, hyperinsulinemia and chronic inflammation. Metformin, a first-line medication for type 2 diabetes mellitus, arouses growing concerns on its anti-cancer effect. However, data regarding the effect of glibenclamide on tumor growth and cancer risk are less consistent, which may be a potential anti-cancer drug. Areas covered: In this review, we clarified probable underlying mechanisms in preclinical studies and reviewed epidemiological evidence on glibenclamide's cancer risk in clinical studies...
July 2017: Expert Opinion on Investigational Drugs
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