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Expert Opinion on Investigational Drugs

Joseph Cioccio, David Claxton
Tyrosine kinases (TKs) drive cell survival and proliferation in many normal and malignant cell types. TKs are frequently mutated in acute myeloid leukemia (AML) and hence are increasingly targeted. The management of AML has dramatically improved because of TKI-targeted treatment. Areas Covered: This review provides a biological background for TK inhibitors (TKIs) in AML and reviews their use in the clinic. TK expression and mutation in AML are explored with a focus on TKs associated with specific AML subsets and treatment outcomes...
February 18, 2019: Expert Opinion on Investigational Drugs
Avani Athauda, Ian Chau
No abstract text is available yet for this article.
February 15, 2019: Expert Opinion on Investigational Drugs
Travis J Carlson, Bradley T Endres, Eugénie Bassères, Anne J Gonzales-Luna, Kevin W Garey
Ridinilazole is a novel antibiotic being developed for the treatment of Clostridioides difficile infection (CDI). Ridinilazole has completed two phase II trials and phase III trials which are denoted Ri-CoDIFy 1 and 2, are planned ( identifiers: NCT03595553 and NCT03595566). Areas covered: This article covers the chemistry, mechanism of action, in vitro microbiology versus C. difficile and host microbiota, pre-clinical and clinical efficacy, pharmacokinetics, pharmacodynamics and safety and tolerability of ridinilazole...
February 15, 2019: Expert Opinion on Investigational Drugs
Olgun Elicin, Nikola Cihoric, Eugenia Vlaskou Badra, Mahmut Ozsahin
Head and neck cancer (HNC) is an immunosuppressive disease that demonstrates heterogeneous molecular characteristics and features of tumor-host interaction. Beside radiotherapy and surgery, the current standard of care in systemic treatment involves the use of cytotoxic chemotherapy, monoclonal antibodies (mAbs) and tyrosine kinase inhibitors (TKIs). There are also other modalities being developed under the category of immunotherapy, but they are overshadowed by the recent advancements of immune checkpoint inhibitors...
February 14, 2019: Expert Opinion on Investigational Drugs
Ana Marija Sola, Daniel E Johnson, Jennifer R Grandis
Despite advances in treatment, head and neck squamous cell carcinoma (HNSCC) survival rates remain stagnant. Current treatment is associated with significant toxicities and includes chemotherapy, radiation, surgery and few targeted treatments. Targeted treatments, epidermal growth factor receptor (EGFR)-targeted agent, cetuximab, and immune checkpoint inhibitors, pembrolizumab and nivolumab, show improved toxicity profiles and modestly improved survival in select patients. An urgent need remains to identify novel targeted treatments for single-agent or combined therapy use...
February 12, 2019: Expert Opinion on Investigational Drugs
Mai-Chi N Tran, Ravina Kullar, Ellie Jc Goldstein
Clostridioides (Clostridium) difficile Infection (CDI) is an urgent global threat causing ~500,000 infections annually in the United States of America (USA) and is associated with a 36% 30-day attributable mortality rate. Despite the availability of three therapeutic agents, CDI recurrence occurs in 20-40% of patients, with a 30-40% second recurrence rate in these patients. Consequently, there is a need for novel agents for treating CDI. Areas covered: We searched MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials...
February 12, 2019: Expert Opinion on Investigational Drugs
Dimitrios Milonas, Konstantinos Tziomalos
Despite the substantial reduction in cardiovascular morbidity and mortality after the management of dyslipidemia with statins, residual risk remains even after achieving low-density lipoprotein cholesterol targets. This residual risk appears to be partly attributed to low levels of high-density lipoprotein cholesterol (HDL-C) and high levels of triglycerides (TG). Apolipoprotein C3 (APOC3) is a key regulator of TG metabolism and its targeting may reduce TG levels and cardiovascular risk. Areas covered: We discuss APOC3-targeted experimental treatments for dyslipidemia...
February 12, 2019: Expert Opinion on Investigational Drugs
Polyxeni Ntontsi, Aggeliki Detta, Petros Bakakos, Stelios Loukides, Georgios Hillas
Severe, inadequately-controlled asthma remains a clinical challenge. For this reason, clinical trials and preclinical experimental studies on novel agents as an add-on therapies continue emerge. Phosphodiesterases (PDEs) are enzymes that regulate the function of immune cells by hydrolyzing cyclic guanosine monophosphate/cGMP and cyclic adenosine monophosphate/cAMP. PDEs are divided into subfamilies [PDE3, PDE4, PDE5 and PDE7] which are mainly found in the respiratory tract. Inhibitors of PDEs have already been approved for COPD and pulmonary hypertension...
January 24, 2019: Expert Opinion on Investigational Drugs
Andrea R Genazzani, Ulysse Gaspard, Jean-Michel Foidart
Menopausal symptoms have a substantial effect on the quality of life of many women, hence investigations for the amelioration of menopausal symptoms continue to be necessary. The two main approaches to the amelioration of symptoms are hormone therapy (HT) and non-hormonal therapy. Areas covered: This review provides a background for understanding the types of menopausal symptoms and their underlying physiology. The early clinical development of a natural estrogen (estetrol, E4), neurokinin 3 receptor (NK3R) antagonists and other non-hormonal therapies are covered...
January 24, 2019: Expert Opinion on Investigational Drugs
Enrico Heffler, Luisa Brussino, Stefano Del Giacco, Giovanni Paoletti, Paola Lucia Minciullo, Gilda Varricchi, Guy Scadding, Luca Malvezzi, Armando De Virgilio, Giuseppe Spriano, Francesca Puggioni, Monica Fornero, Giovanni Rolla, Giorgio Walter Canonica
Allergic rhinitis (AR) is the most common allergic disease, and it has a relevant impact on the quality of life of the patient. Treatment of AR includes a combination of strategies of proven efficacy and effectiveness; however, a relevant proportion of patients remain uncontrolled. Areas covered: This review article summarizes emerging therapeutic approaches to AR; these approaches include nasal sprays, oral drugs, alternative allergen immunotherapy administration routes, and biologic agents. Expert opinion: The agents discussed require further clinical trials to prove their efficacy in the treatment of AR...
January 24, 2019: Expert Opinion on Investigational Drugs
Brandon D Philbrick, D Cory Adamson
Glioblastoma and anaplastic astrocytoma are two of the most aggressive and common glioma malignancies in adults. These high-grade gliomas (HGG) universally recur despite aggressive treatment modalities and have a median overall survival (mOS) of approximately 14 months from initial diagnosis. Upon recurrence, there is no standard of care and these patients have a dismal prognosis of around 9 months at time of recurrence. Areas covered: In this article, we assess the newly published phase I data of Toca 511 and Toca FC, a two-drug combination therapy for recurrent HGG (rHGG) tumors, for effectiveness and safety...
January 24, 2019: Expert Opinion on Investigational Drugs
(no author information available yet)
No abstract text is available yet for this article.
January 15, 2019: Expert Opinion on Investigational Drugs
Jorge Ocampo-Garza, Jacob Griggs, Antonella Tosti
Alopecia is a very common complaint in medical practice, which usually has a large psychological impact in patients. Treatment of alopecia is often difficult and frustrating for patients and clinicians owing to the slow growth rate of the hair, long treatment terms, limited efficacy, and possible adverse side effects. Areas covered: This paper reviews the new and emerging treatments for two of the most common forms of alopecia, known as androgenetic alopecia and alopecia areata. A literature search of PubMed/MEDLINE and ClinicalTrial...
January 15, 2019: Expert Opinion on Investigational Drugs
Renee-Marie Ragguett, Carola Rong, Kevin Kratiuk, Roger S McIntyre
Major depressive disorder (MDD) is a debilitating disorder with increasing prevalence globally. Despite the development of novel treatments for MDD, many patients present with treatment resistant depression (TRD), identified by treatment non-response following one or more adequate trials of an antidepressant. Rapastinel may prove to be a viable treatment for TRD; it has the potential to produce a rapid antidepressant response without serious adverse events and improve functional symptoms. Areas covered: We review the efficacy of rapastinel via completed and on-going clinical trials...
December 26, 2018: Expert Opinion on Investigational Drugs
Srikanth Yandrapalli, Gabriela Andries, Shashvat Gupta, Abdel Rahman Dajani, Wilbert S Aronow
Advances in our understanding of the complex pathophysiologic mechanisms responsible for high-risk atherosclerotic plaque rupture resulting in acute myocardial infarction (AMI) have led to the development of numerous antiplatelet and anticoagulant agents for treatment of AMI. Areas covered: We review various antithrombotic drugs which were recently investigated for the treatment of AMI. A MEDLINE search for relevant articles on newer antiplatelet agents and anticoagulants drugs for the treatment of AMI was performed, and important original investigations were reviewed...
December 22, 2018: Expert Opinion on Investigational Drugs
Juliana Boex Mengue, Jana Held, Andrea Kreidenweiss
AQ-13 is a drug candidate in development for the treatment of p. falciparum infections. The chemical structure is similar to chloroquine, a 4-aminoquinoline, with a shorter diaminoalkane side chain. Chloroquine has been the standard of care for P. falciparum malaria for more than 40 years but the spread of resistant parasites in all malaria endemic regions has led to abandonment of the drug. The outstanding attribute of AQ-13 is its retrieval of activity against chloroquine resistant P. falciparum. Areas covered: We review preclinical and clinical studies on AQ-13 and summarize findings on pharmacokinetic, safety, potency and efficacy...
December 21, 2018: Expert Opinion on Investigational Drugs
Fabio Barra, Giulio Evangelisti, Lorenzo Ferro Desideri, Stefano Di Domenico, Domenico Ferraioli, Valerio Gaetano Vellone, Franco De Cian, Simone Ferrero
Endometrial cancer (EC) is the most common neoplasm of the female genital tract in developed countries. Despite the progress in early detection and treatment, a significant number of cases of advanced ECs are still diagnosed. These patients have few treatment options and a poor prognosis. Our understanding of EC pathogenesis and progression has been enhanced by recent genomic studies. Among the relevant biological pathways, phosphatidylinositol 3-kinase/AKT (PIK3/AKT)-mammalian target of rapamycin (mTOR) signaling is frequently upregulated in this cancer...
December 21, 2018: Expert Opinion on Investigational Drugs
Lea Stitzlein, Pss Rao, Richard Dudley
The incidence of renal cell carcinoma (RCC) has increased in recent years and, unfortunately, many patients initially present with metastatic disease. When surgery is not an option, treatment involves administration of targeted therapies. The vascular endothelial growth factor (VEGF) pathway has been identified as an important mediator for the development of RCC. Numerous agents target VEGF-mediated signaling, yet resistance and progressive disease still persists. Novel small molecule VEGF inhibitors with high affinity for the VEGF receptor (VEGFR) have been discovered and are currently under investigation for the management of RCC...
December 21, 2018: Expert Opinion on Investigational Drugs
Ilit Turgeman, Gil Bar-Sela
A flowering plant of variegated ingredients and psychoactive qualities, Cannabis has long been used for medicinal and recreational purposes. Regulatory approvals have been gained across a broad range of palliative and therapeutic indications, and in some cases, included in standard treatment guidelines. Areas covered: The use of Cannabis and cannabinoid-based-medicines in oncology is summarized in this article. Cannabinoids were classified according to natural and synthetic subtypes and their mechanisms of action expounded...
December 20, 2018: Expert Opinion on Investigational Drugs
Taku Fujimura, Takanori Hidaka, Yumi Kambayashi, Setsuya Aiba
Approximately, 30.4-66.0% of cutaneous melanomas possess a mutation in the BRAF gene that activates downstream signaling through the mitogen-activated protein (MAP) kinase pathway; this provides an attractive target for the treatment of advanced melanoma. Although BRAF inhibitors rapidly suppress melanoma growth, median progression-free survival remains unsatisfactory. Recent clinical trials have investigated drugs that can optimally enhance and prolong the anti-melanoma effects of BRAF inhibitors. Area covered: This review discusses the development of BRAF inhibitor-based combination therapies for BRAF-mutant advanced melanoma...
December 16, 2018: Expert Opinion on Investigational Drugs
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