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Expert Opinion on Investigational Drugs

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https://www.readbyqxmd.com/read/29228840/investigational-pd-1-inhibitors-in-hl-and-nhl-and-biomarkers-for-predictors-of-response-and-outcome
#1
Andres Chang, Danielle Schlafer, Christopher R Flowers, Pamela B Allen
Inhibitors against the PD-1/PD-L1 pathway are revolutionizing the treatment and management of malignancies. Areas covered: We summarize our current understanding of the function of PD-1, its role in immune evasion, the clinical data available that support the use of PD-1 antagonist in Hodgkin and non-Hodgkin lymphomas, and potential predictors of response. Expert opinion: We anticipate that in the next 10 years, agents that modulate the immune system such as PD-1 antagonists will be increasingly used in favor over traditional cytotoxic chemotherapeutic agents...
December 12, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29226721/investigational-drugs-in-phase-i-and-phase-ii-clinical-trials-for-hereditary-angioedema
#2
Henriette Farkas, Márta Lídia Debreczeni, Kinga Viktória Kőhalmi
Hereditary angioedema (HAE) with C1-inhibitor deficiency (C1-INH-HAE) is a rare bradykinin-mediated disease characterized by recurrent subcutaneous and/or submucosal angioedematous attacks (HAE attacks), which occur unpredictably. The recurrent HAE attacks do not respond to conventional treatments, and may evolve into a life-threatening condition; therefore, special therapy is required. Areas covered: The agents used so far for the acute management of HAE attacks act by blocking the release of bradykinin, or its binding to its receptor...
December 11, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29224364/new-anticoagulants-for-venous-thromboembolism-and-atrial-fibrillation-what-the-future-holds
#3
Gerasimos Dimitropoulos, S M Zubair Rahim, Alexandra Sophie Moss, Gregory Y H Lip
Introduction The field of anticoagulation has seen impressive progress over the last decade. The introduction of the Non Vitamin K Oral Anticoagulants (NOACs) has revolutionized practice surrounding thromboprophylaxis, treatment of thromboembolic disease and stroke prevention in atrial fibrillation (AF). However, the search for the "holy grail" of anticoagulation, an agent that combines optimal efficacy with minimal bleeding diathesis, continues. Areas covered In this paper we aim to summarize the current evidence from pre-clinical studies and early phase clinical trials, presenting the pharmacodynamic and pharmacokinetic properties as well as the safety and efficacy profiles of the most important antithrombotic agents in development...
December 9, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29216787/mek-inhibitors-under-development-for-treatment-of-non-small-cell-lung-cancer
#4
Chul Kim, Giuseppe Giaccone
The mitogen-activated protein kinase (MAPK) pathway is intimately implicated in the molecular pathogenesis of non-small-cell lung cancer (NSCLC). Aberrant MAPK signaling resulting from the upstream activating mutations converges on mitogen-activated protein kinase kinase 1/2 (MEK1/2), making MEK inhibition an attractive strategy for the treatment of NSCLC. Several MEK inhibitors have demonstrated anticancer activity in patients with NSCLC. Areas covered: In this article, we discuss the biological rationale for the use of MEK inhibitors and summarize the clinical experience with MEK1/2 inhibitors for the treatment of NSCLC, from initial phase I studies to phase II/III studies, both as monotherapy or in combination with other anticancer agents...
December 7, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29188733/investigational-drugs-in-clinical-trials-for-hidradenitis-suppurativa
#5
Peter Theut Riis, Linnea R Thorlacius, Gregor B Jemec
Hidradenitis suppurativa is a chronic skin disease with a significant unmet need for treatment options. Randomized controlled trials are few and only a single drug (adalimumab) has Hidradenitis as a registered indication. Areas covered: The clinicaltrials.gov and the EudraCT clinical trials register for reported trials on Hidradenitis Suppurativa was searched on the 22-06-2017. Trials for upcoming new drugs for HS are reported focusing on drugs in phase I and II trials. Expert opinion: Currently, MABp1, Secukinumab, CJM112, Apremilast and IFX-1 are being investigated in Phase I and II trials and offer theoretical and promising new treatment options...
November 30, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29125406/bruton-s-tyrosine-kinase-inhibitors-first-and-second-generation-agents-for-patients-with-chronic-lymphocytic-leukemia-cll
#6
Philip A Thompson, Jan A Burger
The BTK inhibitor ibrutinib is effective in both low- and high-risk CLL patients, achieving durable remissions with continuous therapy in the majority of patients. Ibrutinib lacks myelotoxicity and is generally well tolerated by older and unfit patients; however, side effects, such as atrial fibrillation or hemorrhage, can result in treatment interruption or discontinuation. Given the high efficacy and overall safety, ibrutinib is increasingly used in untreated and previously treated CLL patients. Second-generation BTK inhibitors are being developed, with different and generally more BTK-selective kinase inhibition profiles, which may increase the safety and/or efficacy...
November 10, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29065735/phase-i-and-ii-clinical-trials-for-the-mucopolysaccharidoses
#7
Fabiano Poswar, Guilherme Baldo, Roberto Giugliani
The mucopolysaccharidoses are lysosomal diseases characterized by deficient activity of one of the enzymes that degrades glycosaminoglycans. Treatment options are limited; therefore, new treatments are under investigation. Areas covered: We review the medicinal products for the treatment of mucopolysaccharidoses that are currently being investigated in phase I and phase II clinical trials. Expert opinion: The number of alternatives to treat MPS diseases increased dramatically in an attempt to provide therapy options for orphan MPS diseases and to address the unmet needs of the MPS that already have a treatment available...
October 31, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29050521/glutamate-receptor-antagonists-with-the-potential-for-migraine-treatment
#8
Anna Ferrari, Cecilia Rustichelli, Carlo Baraldi
Preclinical, clinical, and other (e.g., genetic) evidence support the concept that migraine susceptibility may at least partially result from a glutamatergic system disorder. Therefore, the receptors of the glutamatergic system are considered relatively new targets for investigational drugs to treat migraine. Investigational and established glutamate receptor antagonists (GluRAs) have been shown to possess antinociceptive properties in preclinical models of trigeminovascular nociception and have been evaluated in clinical trials...
October 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29032717/bet-inhibitors-in-metastatic-prostate-cancer-therapeutic-implications-and-rational-drug-combinations
#9
Mark C Markowski, Angelo M De Marzo, Emmanuel S Antonarakis
The bromodomain and extra-terminal (BET) family of proteins are epigenetic readers of acetylated histones regulating a vast network of protein expression across many different cancers. Therapeutic targeting of BET is an attractive area of clinical development for metastatic castration-resistant prostate cancer (mCRPC), particularly due to its putative effect on c-MYC expression and its interaction with the androgen receptor (AR). Areas covered: We speculate that a combination approach using inhibitors of BET proteins (BETi) with other targeted therapies may be required to improve the therapeutic index of BET inhibition in the management of prostate cancer...
October 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29053394/vedroprevir-in-the-management-of-hepatitis-c-virus-infection
#10
Ameer Abutaleb, Shyamasundaran Kottilil
Hepatitis C Virus (HCV) is a chronic infection of the liver and the leading cause of liver failure and liver transplantation worldwide. While prior HCV therapies were prolonged and had variable success rates, the advent of direct-acting antivirals (DAAs) has dramatically improved HCV therapy with minimal side effects, shorter treatment durations, and higher cure rates. Areas covered: In this paper, we review the literature discussing the use of Vedroprevir (GS-9451) in treatment of HCV in a variety of patient populations...
October 26, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29052441/investigational-glucagon-receptor-antagonists-in-phase-i-and-ii-clinical-trials-for-diabetes
#11
André J Scheen, Nicolas Paquot, Pierre J Lefèbvre
Despite type 2 diabetes (T2D) being recognized as a bihormonal pancreatic disease, current therapies are mainly focusing on insulin, while targeting glucagon has been long dismissed. However, glucagon receptor (GCGr) antagonists are currently investigated in clinical trials. Area covered: Following a brief description of the rationale for antagonizing GCGr in T2D, lessons from GCGr knock-out mice and pharmacological means to antagonize GCGr, a detailed description of the main results obtained with GCGr antagonists in Phase I-II clinical trials is provided...
October 26, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29046065/investigational-pd-1-inhibitors-for-advanced-non-small-lung-cancer-new-players-in-a-shifting-paradigm
#12
Sassine Ghanem, Gautam Krichore Valecha, Sami Hossri, Uroosa Ibrahim, Jean Paul Atallah
No abstract text is available yet for this article.
October 24, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29027483/cdk4-6-blockade-in-breast-cancer-current-experience-and-future-perspectives
#13
Dimitrios Zardavas, Noam Pondé, Konstantinos Tryfonidis
Dysregulated cellular proliferation, one of the hallmarks of cancer, is mediated by aberrant activation of the cell cycle machinery through the biological effects of cyclin-dependent kinases (CDKs). The clinical development of non-selective CDK inhibitors failed due to combined lack of efficacy and excessive toxicity reported by clinical trials across different cancer types. The clinical development of second generation, CDK4/6-selective inhibitors, namely palbociclib, abemaciclib and ribociclib, led to practice-changing results in the setting of breast cancer...
October 23, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28984489/directing-the-use-of-ddr-kinase-inhibitors-in-cancer-treatment
#14
Inger Brandsma, Emmy D G Fleuren, Chris T Williamson, Christopher J Lord
Defects in the DNA damage response (DDR) drive the development of cancer by fostering DNA mutation but also provide cancer-specific vulnerabilities that can be exploited therapeutically. The recent approval of three different PARP inhibitors for the treatment of ovarian cancer provides the impetus for further developing targeted inhibitors of many of the kinases involved in the DDR, including inhibitors of ATR, ATM, CHEK1, CHEK2, DNAPK and WEE1. Areas covered: We summarise the current stage of development of these novel DDR kinase inhibitors, and describe which predictive biomarkers might be exploited to direct their clinical use...
October 14, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29068253/topical-e6005-rvt-501-a-novel-phosphodiesterase-4-inhibitor-for-the-treatment-of-atopic-dermatitis
#15
REVIEW
Masutaka Furue, Takafumi Kadono, Gaku Tsuji, Takeshi Nakahara
Local adverse effects of steroid use and the burning sensation of calcineurin inhibitors impair patients' adherence to treatment and decrease the treatment response in atopic dermatitis (AD). Steroid phobia appears to be a psychological problem in patients with AD. Topical non-steroidal remedies are in demand. Areas covered: This manuscript reviews the current literature on preclinical and clinical studies regarding topical E6005/RVT-501, a novel phosphodiesterase 4 inhibitor. We also discuss the mechanistic background of E6005/RVT-501 in the treatment of AD...
December 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28972395/venetoclax-for-the-treatment-of-chronic-lymphocytic-leukemia
#16
REVIEW
Massimo Gentile, Annamaria Petrungaro, Giuseppina Uccello, Ernesto Vigna, Anna Grazia Recchia, Nadia Caruso, Sabrina Bossio, Laura De Stefano, Angela Palummo, Francesca Storino, Massimo Martino, Fortunato Morabito
Venetoclax, an orally bioavailable inhibitor of BCL-2, was approved in 2016 by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL) patients with 17p deletion [del(17p)], who have received at least one prior therapy. Areas covered: We focus on the mechanism of action of venetoclax and on the clinical trial data that led to the approval of venetoclax for CLL patients. We also review the studies in which this drug has being explored in combination with other anti-CLL drugs...
November 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28965421/safety-and-efficacy-of-nintedanib-for-the-treatment-of-metastatic-colorectal-cancer
#17
REVIEW
Maria Carmen Riesco-Martinez, Ana Sanchez-Torre, Rocio Garcia-Carbonero
Nintedanib (BIBF 1200) is an oral tyrosine kinase inhibitor that targets the vascular endothelial growth factor (VEGFR), platelet-derived growth factor (PDGFR) and fibroblast growth factor (FGFR) receptors. It is approved in Europe in combination with docetaxel for patients with advanced lung adenocarcinoma who have progressed to first-line chemotherapy. However, its role in the treatment of metastatic colorectal cancer (mCRC) is uncertain. Recent results from the LUME-Colon 1 pivotal phase III trial showed only a marginal increase in progression free survival over placebo in refractory mCRC patients, with a toxicity profile similar to other antiangiogenic agents, and no benefit in overall survival...
November 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28956664/investigational-hiv-integrase-inhibitors-in-phase-i-and-phase-ii-clinical-trials
#18
REVIEW
Yingshan Han, Thibault Mesplède, Mark A Wainberg
To date, three HIV integrase strand transfer inhibitors (INSTIs), i.e. raltegravir, elvitegravir and dolutegravir, have been approved for clinical use. Recent research has focused on new integrase inhibitors including those targeting non-catalytic sites of HIV integrase. Areas covered: This paper reviews two investigational INSTIs in phase I and II clinical trials, bictegravir (BIC) and cabotegravir (CAB), as well as an investigational noncatalytic integrase inhibitor (NCINI) termed BI 224436. Expert opinion: Data from phase I and II clinical trials demonstrate that CAB has good efficacy and is well-tolerated...
November 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28952411/clinical-development-of-mtor-inhibitors-for-renal-cancer
#19
REVIEW
Michele Ghidini, Fausto Petrelli, Antonio Ghidini, Gianluca Tomasello, Jens Claus Hahne, Rodolfo Passalacqua, Sandro Barni
Renal cell carcinoma (RCC) accounts for approximately 3% of adult malignancies and 90-95% of neoplasms arising from the kidney. In the last 10 years, clinical trials have established multitargeted tyrosine kinase inhibitors (TKIs) as the standard first-line treatment in patients with metastatic disease. Multiple agents are now available for treatment in subsequent lines.The mammalian target of rapamycin (mTOR) inhibitors (e.g., everolimus alone or with lenvatinib) are among the most effective options. Areas covered: This paper provides a complete and updated overview on mTOR inhibitors for the treatment of advanced RCC...
November 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28952409/targeting-triple-negative-breast-cancer-with-histone-deacetylase-inhibitors
#20
REVIEW
Palma Fedele, Laura Orlando, Saverio Cinieri
Triple negative breast cancer (TNBC) is a heterogeneous disease characterized by poor outcomes, higher rates of relapse, lack of biomarkers for rational use of targeted treatments and insensitivity to current available treatments. Histone deacetylase inhibitors (HDACis) perform multiple cytotoxic actions and are emerging as promising multifunctional agents in TNBC. Areas covered: This review focuses on the challenges so far addressed in the targeted treatment of TNBC and explores the various mechanisms by which HDACis control cancer cell growth, tumor progression and metastases...
November 2017: Expert Opinion on Investigational Drugs
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