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FDA Approved Treatment

M De Santis
BACKGROUND: Prostate cancer (PCA) seems to be more of an immunologic desert than other tumor entities. It is striking that only rarely does prostate cancer show abundant immune cells and a proimmunogenic microenvironment. OBJECTIVES: Is immunotherapy in PCA effective and which patients can benefit. MATERIALS AND METHODS: A review of the literature and recent congress data are presented. RESULTS: Preliminary results with sipuleucel-T for PCA cancer were very promising showing a significant overall survival benefit in randomised phase III studies and the US Federal Drug Administration (FDA) approval for this individualised vaccine...
October 19, 2018: Der Urologe. Ausg. A
Lilian Abbo, Bhavarth S Shukla, Amber Giles, Laura Aragon, Adriana Jimenez, Jose F Camargo, Jacques Simkins, Kathleen Sposato, Truc T Tran, Lorena Diaz, Jinnethe Reyes, Rafael Rios, Lina P Carvajal, Javier Cardozo, Maribel Ruiz, Gemma Rosello, Armando Perez Cardona, Octavio Martinez, Giselle Guerra, Thiago Beduschi, Rodrigo Vianna, Cesar A Arias
Background: Vancomycin-resistant enterococci are an important cause of healthcare-associated infections and are inherently resistant to many commonly used antibiotics. Linezolid is the only drug currently approved by the Food and Drug Administration (FDA) to treat vancomycin-resistant enterococci, however resistance to this antibiotic appears to be increasing. Although outbreaks of linezolid- and vancomycin-resistant Enterococcus faecium (LR-VRE) in solid organ transplant recipients remain uncommon, they represent a major challenge for infection control and hospital epidemiology...
October 18, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Alison D Treister, Peter A Lio
BACKGROUND/OBJECTIVES: Clinical trials of dupilumab have shown efficacy in treating moderate-to-severe atopic dermatitis (AD) in adult patients. While a phase 2 trial of dupilumab has shown efficacy and safety in children, the medication awaits Food and Drug Administration (FDA) approval, and off-label use is limited by dosing currently available to adults. We present this case series to describe the efficacy and safety profile of off-label dupilumab use in six pediatric patients treated by one provider in a private practice...
October 18, 2018: Pediatric Dermatology
Soren Hayrabedyan, Krassimira Todorova, Marialuigia Spinelli, Eytan R Barnea, Martin Mueller
The central pathological feature of Alzheimer's disease (AD) is the sequential proteolytic processing of amyloid precursor protein (APP) to amyloid-β peptides (Aβ) agglomeration. The clearance of Aβ may be induced by the large zinc-binding protease insulin degrading enzyme (IDE). IDE is the common link between AD and Type II diabetes as insulin is an IDE target as well. Not surprisingly, the search for safe and effective drugs modulating IDE is ongoing. A new pregnancy derived peptide, PreImplantation Factor (PIF), inhibits neuro-inflammation and crosses the blood-brain-barrier...
September 21, 2018: Oncotarget
Rakesh K Pathak, Uttara Basu, Anis Ahmad, Shrita Sarkar, Anil Kumar, Bapurao Surnar, Saba Ansari, Katarzyna Wilczek, Michael E Ivan, Brian Marples, Nagesh Kolishetti, Shanta Dhar
Multimodal therapies are used to treat advanced cancers including castration-resistant prostate cancer to manage the biological characteristics of the tumors like inflammation, bone metastases, and participation of metabolically altered cancer stem cells (CSCs) that have integral roles in disease dissemination and progression. We developed a multifunctional polymer-based self-assembled technology to deliver a predefined stoichiometric combination of a chemotherapy and an anti-inflammatory agent in a stimuli responsive manner, to complement and improve the currently established treatment methods of prostate cancer...
September 5, 2018: Biomaterials
M Oellerich, E Schütz, J Beck, P D Walson
Genomic analyses in oncologic care allow for the development of more precise clinical laboratory tests that will be critical for personalized pharmacotherapy. Traditional biopsy-based approaches are limited by the availability of sequential tissue specimens to detect resistance. Blood-based genomic profiling ("liquid biopsy") is useful for longitudinal monitoring of tumor genomes and can complement biopsies. Tumor-associated mutations can be identified in cell-free tumor DNA (ctDNA) from patient blood samples and used for monitoring disease activity...
October 16, 2018: Therapeutic Drug Monitoring
Virginia Miraldi Utz, Razek Georges Coussa, Fares Antaki, Elias I Traboulsi
Significant discoveries in the etiology and pathogenesis of inherited retinal diseases (IRDs) have been made in the last few decades. Of the large number genes that cause IRDs, bi-allelic mutations in RPE65 lead to Leber Congenital Amaurosis type 2 (LCA 2), and can also result in phenotypes described as severe early childhood onset retinal dystrophy (SECORD) and Retinitis pigmentosa 20 (RP20). Following the publication of the successful Phase-III clinical trials of gene augmentation surgery for RPE65-related IRDs with voretigene neparvovec, the FDA approved the commercial use of this pharmacologic agent in December 2017...
October 18, 2018: Ophthalmic Genetics
Rasha Shaaban, Wael M El-Sayed, Safia Samir, Ehab El-Dabaa
Recombinant human interferon alpha2b (rhIFN-α2b) protein is FDA approved for treatment of many tumors and viral diseases. A rhIFN-α2b isoform has been produced and purified from the refolding reaction using high-resolution anion ion exchange chromatography. This isoform has a proper MW (19 kDa) and high purity and homogeneity. The conservation of native linear and conformational epitopes in this isoform was immunologically confirmed by Western blot and ELISA. Mass spectrometry assessment of its intact mass showed average mass (19,337 Da) equivalent to that of the expressed rhIFN-α2b protein without any chemical modification and without the first methionine...
October 18, 2018: Applied Biochemistry and Biotechnology
Sunanda Kane
Infliximab was the first FDA approved biologic for the treatment of Crohn's disease. Data for its use before and during pregnancy in both females and males have been increasing over the last decade, but most studies have had fewer than 100 patients and inconsistent comparison to healthy control outcomes. New data from the TREAT Safety Registry have a robust N of female and male patients exposed to infliximab with known birth outcomes from both academic and community settings. There does not appear to be any increase in adverse pregnancy outcomes from this population...
October 17, 2018: American Journal of Gastroenterology
Hee Yeon Kim, Dong Keon Kim, Seung-Hyun Bae, HyeRan Gwak, Ji Hoon Jeon, Jong Kwang Kim, Byung Il Lee, Hye Jin You, Dong Hoon Shin, Young-Ho Kim, Soo Youl Kim, Sung-Sik Han, Jin-Kyoung Shim, Ji-Hyun Lee, Seok-Gu Kang, Hyonchol Jang
Glioblastoma is a highly malignant tumor that easily acquires resistance to treatment. The stem-cell-like character (stemness) has been thought to be closely associated with the treatment resistance of glioblastoma cells. In this study, we determined that farnesyl diphosphate synthase (FDPS), a key enzyme in isoprenoid biosynthesis, plays an important role in maintaining glioblastoma stemness. A comparison of the mRNA expression in patient-derived glioblastoma sphere cells, which maintain stemness, and their differentiated counterparts, which lose stemness, via RNA sequencing showed that most of the altered genes were networked in the cholesterol biosynthesis pathway...
October 17, 2018: Experimental & Molecular Medicine
Raanan Tal
No abstract text is available yet for this article.
October 17, 2018: International Journal of Impotence Research
Vivek Kumar Singh, Mohane Selvaraj Coumar
Chronic myeloid leukemia (CML) is a myeloproliferative disease caused due to translocation between chromosome 9 and 22 leading to chimeric gene product known as Bcr-Abl. Bcr-Abl fusion protein has constitutively activated Abl tyrosine kinase activity which is responsible for the uncontrolled proliferation in CML The tyrosine kinase inhibitors (TKIs) such as Imatinib, Dasatinib, and Nilotinib are the current firstline treatments approved by the United States Food and Drug Administration (US FDA) for the treatment of the disease...
October 17, 2018: Mini Reviews in Medicinal Chemistry
Loredana Cappellacci, Diego R Perinelli, Filippo Maggi, Mario Grifantini, Riccardo Petrelli
Histone deacetylase (HDAC) inhibitors are a relatively new class of anti-cancer agents that play important roles in epigenetic or non-epigenetic regulation, inducing death, apoptosis, and cell cycle arrest in cancer cells. Recently, their use has been clinically validated in cancer patients resulting in the approval by the FDA of four HDAC inhibitors, vorinostat, romidepsin, belinostat and panobinostat, used for the treatment of cutaneous/peripheral T-cell lymphoma and multiple myeloma. Many more HDAC inhibitors are in different stages of clinical development for the treatment of hematological malignancies as well as solid tumors...
October 16, 2018: Current Medicinal Chemistry
Nicola E Natsis, Alice B Gottlieb
Psoriasis and psoriatic arthritis are common diseases with significant physical and emotional burden. Several biologics are FDA-approved to treat psoriasis and psoriatic arthritis, though some patients remain refractory to, or have lost response to, therapy and/or cannot tolerate the associated risks and side effects. Bimekizumab is a new biologic that inhibits both IL-17A and IL-17F. It is currently in phase III clinical trials. To date, phase II studies show promise in its ability to rapidly resolve symptoms while remaining safe and well-tolerated...
October 18, 2018: Expert Opinion on Biological Therapy
Oscar Teijido, Ramón Cacabelos
Cerebrovascular and neurodegenerative disorders affect one billion people around the world and result from a combination of genomic, epigenomic, metabolic, and environmental factors. Diagnosis at late stages of disease progression, limited knowledge of gene biomarkers and molecular mechanisms of the pathology, and conventional compounds based on symptomatic rather than mechanistic features, determine the lack of success of current treatments, including current FDA-approved conventional drugs. The epigenetic approach opens new avenues for the detection of early presymptomatic pathological events that would allow the implementation of novel strategies in order to stop or delay the pathological process...
October 16, 2018: International Journal of Molecular Sciences
Rocio Garcia-Santibanez, Matthew Burford, Robert C Bucelli
PURPOSE OF REVIEW: This article provides an overview of recent advancements in the fields of hereditary motor neuropathies and ALS. RECENT FINDINGS: There has been a robust growth in our knowledge and understanding of hereditary and degenerative motor neuronopathies/neuropathies over the last decade. Many breakthroughs in the field of hereditary motor neuropathies (HMN) have been associated with identification and characterization of the genes and molecular mechanisms underlying these disorders...
October 17, 2018: Current Neurology and Neuroscience Reports
Elihu H Estey
Outcome in patients with acute myeloid leukemia (AML) ranges from death within a few days of beginning treatment (treatment related mortality, TRM) to likely cure. The major reason patients are not cured is resistance to treatment, often manifested as relapse from remission, rather than, even in older patients, TRM, whose incidence is decreasing. Knowledge of the pre-treatment mutation status of various genes has improved our ability to assign initial treatment and, of particular importance, knowledge of whether patients ostensibly in remission have measurable residual disease should influence subsequent management...
October 2018: American Journal of Hematology
H Ramamoorthy, P Abraham, B Isaac, D Selvakumar
Tenofovir disoproxil fumarate (TDF) is currently the only nucleotide analogue reverse-transcriptase inhibitor that is approved by the Food and Drug administration (FDA), USA, for the treatment of human immunodeficiency virus (HIV) infection. In recent days, renal toxicity is becoming common i HIV patients treated with TDF. However, the mechanism of tenofovir nephrotoxicity is not clear. We hypothesized that mitochondrial pathway of apoptosis, poly [ADP-ribose] polymerase (PARP) overactivation and neutrophil infiltration may contribute to tenofovir-induced renal damage...
October 16, 2018: Human & Experimental Toxicology
Xiaoge Gao, Xiangye Liu, Wenhua Shan, Qian Liu, Chao Wang, Jiwei Zheng, Hong Yao, Renxian Tang, Junnian Zheng
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, and is the third most frequent cause of cancer-related deaths worldwide. The development of safe new anti-tumor agents has become increasingly important due to the steady rise in drug-resistant tumors. After assessing the efficacy of several candidate compounds that could inhibit hepatocellular carcinoma, we focused on atovaquone, an FDA-approved anti-malarial drug. In the present study, we found that atovaquone significantly inhibited hepatoma cell proliferation via S phase cell cycle arrest and both extrinsic and intrinsic apoptotic pathway induction associated with upregulation of p53 and p21...
2018: American Journal of Cancer Research
Rutika Mehta, Anand Shah, Khaldoun Almhanna
Gastric and esopahgeal cancers account for the six most common causes of cancer death worldwide. Locally advanced resectable cancers have a 5-year life expectancy of 30%. Despite use of chemotherapy, median overall survival for stage IV cancer rarely exceeds 1 year. A subset of gastric cancers such as microsatellite-instable tumor and Epstein-Barr virus-positive tumors have a rich immune infiltrate that makes them more responsive to immune-directed therapies. Tumors can evade T-cell-mediated "immune surveillance" by activating the programmed cell death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1) pathway...
2018: OncoTargets and Therapy
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