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Expert Opinion on Investigational Drugs

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https://www.readbyqxmd.com/read/28267385/clinical-development-landscape-in-gist-from-novel-agents-that-target-accessory-pathways-to-revisiting-non-targeted-therapies
#1
Kamalesh K Sankhala
Activating mutations in the genes encoding the tyrosine receptor kinases KIT and platelet-derived growth factor receptor occur in 85%-90% of patients with gastrointestinal stromal tumors (GIST). Although imatinib and other tyrosine kinase inhibitors have revolutionized the treatment of GIST, most patients progress within a few years. Areas covered: Monoclonal antibodies and small-molecule inhibitors targeting specific signaling pathways or proteins associated with resistance to existing treatments are being explored as alternative treatment approaches for GIST...
March 20, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28264599/bimatoprost-for-the-treatment-of-eyelash-eyebrow-and-scalp-alopecia
#2
Yevher Lorena Barrón-Hernández, Antonella Tosti
Alopecia is a common condition observed among people of all ages. It is a disorder that can involve only the scalp as observed in androgenetic alopecia or scalp and body as in alopecia areata or patients under chemotherapy treatment. There are several treatment options with different safety and efficacy outcomes. Bimatoprost, a synthetic prostamide F2α analog originally approved for the treatment of ocular hypertension and open-angle glaucoma, is now FDA approved as a 0.03%, solution to be applied once daily to increase eyelashes growth...
March 16, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28290731/a-randomized-double-blind-single-dose-two-arm-parallel-study-comparing-pharmacokinetics-immunogenicity-and-tolerability-of-branded-adalimumab-and-its-biosimilar-lbal-in-healthy-male-volunteers
#3
Kyoung Ryun Park, Hyewon Chung, Sung Mo Yang, SeungHwan Lee, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu
OBJECTIVES: This study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira(®), in healthy volunteers. METHODS: A randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs)...
March 14, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28277881/drugs-in-clinical-development-for-the-treatment-of-amyotrophic-lateral-sclerosis
#4
Ana Martinez, Maria Del Valle Palomo Ruiz, Daniel I Perez, Carmen Gil
Amyotrophic Lateral Sclerosis (ALS) is a fatal motor neuron progressive disorder for which no treatment exists to date. However, there are other investigational drugs and therapies currently under clinical development may offer hope in the near future. Areas covered: We have reviewed all the ALS ongoing clinical trials (until November 2016) and collected in Clinicaltrials.gov or EudraCT. We have described them in a comprehensive way and have grouped them in the following sections: biomarkers, biological therapies, cell therapy, drug repurposing and new drugs...
March 14, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28286992/cadazolid-for-the-treatment-of-clostridium-difficile
#5
Bradley T Endres, Eugénie Bassères, M Jahangir Alam, Kevin W Garey
Antibiotic development goals for CDI include potent antimicrobial effect against C. difficile, limited killing of host microbiota, potential effect on spores, and ability to interfere with toxin production. Cadazolid, a novel, non-absorbable hybrid antibiotic has many of these criteria. In phase I and II clinical trials, cadazolid was shown to be safe, well tolerated, and efficacious positioning itself as a potential future viable therapeutic option for CDI. Areas covered: This review provides an in-depth evaluation of the chemistry, microbiology, pharmacodynamics, pharmacokinetics, and clinical trial results for cadazolid...
March 13, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28277884/investigational-drugs-for-treatment-of-juvenile-idiopathic-arthritis
#6
Angela Mauro, Donato Rigante, Rolando Cimaz
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in childhood. The improvement of knowledge about the pathogenetic mechanisms of JIA and advances in the understanding of pathways linking inflammation and autoimmunity and functions of multiple transcription factors have translated into new drug development for a tailored treatment directed to specific subpopulations of JIA patients. Areas covered: This review provides a digest of new investigational drugs which are currently or have been recently tested for treatment of JIA, and highlights some early phase clinical trials on rilonacept, givinostat, daclizumab, tofacitinib, and sarilumab...
March 12, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28277883/prucalopride-for-the-treatment-of-ileus
#7
Christopher J Smart, Kamran I Malik
Postoperative ileus (POI) is an impairment of coordinated gastrointestinal (GI) motility that develops as a consequence of abdominal surgery and is a major factor contributing to patient morbidity and prolonged hospitalisation. Despite the availability of various options its treatment is still under debate. This review will focus on effect of Prucalopride (5-HT4 receptor agonist) on postoperative ileus based on the existing literature. Areas covered: A literature search of MEDLINE, EMBASE and COCHRANE Library was performed concerning topics related to the treatment of ileus with prucalopride...
March 10, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28277882/investigational-therapies-for-squamous-cell-lung-cancer-from-animal-studies-to-phase-ii-trials
#8
Elaine Shum, Feng Wang, Salem Kim, Roman Perez-Soler, Haiying Cheng
It remains challenging to treat squamous cell lung cancer (SCC) with limited therapeutic options. However, recent breakthroughs in targeted therapies and immunotherapies have shed some light on the management of this deadly disease. Areas covered: The article first reviews the current treatment options for advanced SCC, especially recent FDA approved molecular agents (afatinib, ramucirumab and necitumumab) and immunotherapies (nivolumab, pembrolizumab and atezolimumab). We then provide an overview on investigational therapies with data ranging from preclinical to phase II studies, focusing on new cytotoxic agents, emerging molecularly targeted agents (including a PARP inhibitor for Homologous Recombinant Deficiency positive SCC) and novel immunotherapeutic strategies...
March 9, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28274158/heat-shock-protein-antagonists-in-early-stage-clinical-trials-for-nsclc
#9
Lizza E L Hendriks, Anne-Marie C Dingemans
Cancer cells have a higher need of chaperones than normal cells to prevent the toxic effects of intracellular protein misfolding and aggregation. Heat shock proteins (Hsps) belong to these chaperones; they are classified into families according to molecular size. Hsps are upregulated in many cancers and inhibition can inhibit tumor growth by destabilizing proteins necessary for tumor survival. In non-small cell lung cancer (NSCLC), there are three different Hsp antagonist classes that are in (early) clinical trials: Hsp90, Hsp70 and Hsp27 inhibitors...
March 8, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28274154/investigational-drugs-for-the-treatment-of-cervical-cancer
#10
Fabio Barra, Domenica Lorusso, Umberto Leone Roberti Maggiore, Antonino Ditto, Giorgio Bogani, Francesco Raspagliesi, Simone Ferrero
Cervical cancer (CC) is currently the fourth most common malignant disease of women worldwide. Although the incidence and the mortality rates have been decreasing with screening detection and new treatment strategies, a significant number of metastatic or recurrent disease is still diagnosed. For those patients not amenable to curative treatments, such as surgery and radiation, palliative chemotherapy remains the standard of care. As chemotherapy regimens have limited activity, research is focalized on investigating novel pharmacologic strategies...
March 8, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28271910/early-clinical-development-of-epidermal-growth-factor-receptor-targeted-therapy-in-breast-cancer
#11
Naoko Matsuda, Bora Lim, Xiaoping Wang, Naoto T Ueno
Epidermal growth factor receptor (EGFR) targeted treatment has been evaluated but has not shown a clear clinical benefit for breast cancer. This review article aims to consider the knowledge of the biological background of EGFR pathways in dissecting clinical studies of EGFR targeted treatment in breast cancer. Areas covered: This review focuses on the role of the EGFR pathway and the investigational drugs that target EGFR for breast cancer. Expert opinion: Recent studies have indicated that EGFR targeted therapy for breast cancer has some promising effects for patients with triple-negative breast cancer, basal-like breast cancer, and inflammatory breast cancer...
March 8, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28161993/eribulin-in-non-small-cell-lung-cancer-challenges-and-potential-strategies
#12
Umang Swami, Umang Shah, Sanjay Goel
Eribulin is a non-taxane, macrocyclic, synthetic, ketone analog of halichondrin B with a microtubule inhibitory action specific toward 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 22, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28277032/novel-avenues-for-treating-diabetic-nephropathy-new-investigational-drugs
#13
Viviana Lacava, Vincenzo Pellicanò, Carmen Ferrajolo, Valeria Cernaro, Luca Visconti, Giovanni Conti, Michele Buemi, Domenico Santoro
At present, treatment of diabetic kidney disease (DKD) is still mainly based on drugs acting on glycemic and blood pressure control, as there is no validated therapy able to halt the progression of renal failure. Because of the high incidence of DKD, due to the increase of diabetes mellitus in general population, new therapeutic strategies are needed. Areas covered: We analysed ongoing and already completed clinical trials, from clinicaltrials.gov and PubMed, dealing with new therapies for DKD. Expert opinion: Among the drugs currently being explored, the most promising molecules are those that interfere with glucose-dependent pathways, in particular polyol, protein kinase, hexosamine and AGEs metabolic pathways, and impaired renal vascular regulation...
February 17, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28277033/efficacy-of-hydralazine-and-valproate-in-cutaneous-t-cell-lymphoma-a-phase-ii-study
#14
Jose Ramiro Espinoza-Zamora, Juan Labardini-Méndez, Alejandro Sosa-Espinoza, Celia López-González, Magnolia Vieyra-García, Myrna Candelaria, Valentin Lozano-Zavaleta, Diana Vanesa Toledano-Cuevas, Nidia Zapata-Canto, Eduardo Cervera, Alfonso Dueñas-González
OBJECTIVES: To evaluate the activity and safety hydralazine and valproate (Transkrip® in cutaneous T-cell lymphoma (CTCL). METHODS: Previously untreated and progressive/refractory CTCL patients received hydralazine at 83 mg or 182 mg/day for slow and rapid acetylators respectively plus magnesium valproate at a total dose of 30 mg/Kg t.i.d daily in continuous 28-day cycles in this phase II study. The primary objective was overall response rate (ORR) measured by the modified severity weighted assessment tool (m-SWAT), secondary end-points were time to response (TTR), time to progression (TTP), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety...
February 15, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28161988/therapeutic-inhibition-of-bcl-2-and-related-family-members
#15
REVIEW
Michelle A Levy, David F 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...
March 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28141955/investigational-new-drugs-for-allergic-rhinitis
#16
REVIEW
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...
March 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28140696/siltuximab-and-hematologic-malignancies-a-focus-in-non-hodgkin-lymphoma
#17
REVIEW
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...
March 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28127997/investigational-drug-therapies-for-the-treatment-of-gastroparesis
#18
REVIEW
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...
March 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28121208/fgfr-targeted-therapeutics-for-the-treatment-of-breast-cancer
#19
REVIEW
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...
March 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
#20
REVIEW
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...
March 2017: Expert Opinion on Investigational Drugs
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