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Cytotoxic drug safety

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https://www.readbyqxmd.com/read/28098856/anti%C3%A2-wrinkle-effect-of-fermented-black-ginseng-on-human-fibroblasts
#1
Quynh Lien Pham, Hyun-Jun Jang, Kyu-Bong Kim
Fermented black ginseng (FBG) is processed by the repeated steaming and drying of fresh ginseng followed by fermentation with Saccharomyces cerevisiae. It is known to possess anti‑oxidative effects. Skin wrinkle formation is associated with oxidative stress and inflammatory reactions. The aim of this study was to determine whether FBG possesses anti‑wrinkle activity using human fibroblasts (HS68). According to the Korea Ministry of Food and Drug Safety (MFDS) guidelines for the evaluation of the efficacy of functional anti‑wrinkle cosmetics, we attempted to elucidate the effects of FBG on type I procollagen, matrix metalloproteinase (MMP)‑1, MMP‑2, MMP‑9 and tissue inhibitor of metalloproteinase‑2 (TIMP‑2)...
January 16, 2017: International Journal of Molecular Medicine
https://www.readbyqxmd.com/read/28097007/safety-assessment-in-rats-and-dogs-of-acoustic-cluster-therapy-a-novel-concept-for-ultrasound-mediated-targeted-drug-delivery
#2
Oddvar Myhre, Marie Bjørgan, Derek Grant, Svein-Olaf Hustvedt, Per C Sontum, Hubert Dirven
Acoustic Cluster Therapy (ACT) represents a novel concept for targeted drug delivery. Ultrasound is applied to activate intravenously administered free-flowing clusters of microbubbles and microdroplets within the target pathology, depositing 20-30 μm large bubbles in the microvasculature for 5-10 min. Further application of ultrasound induces biomechanical effects which increase vascular permeability and enhance localized extravasation of coadministered drugs. Herein we report investigations done to assess the preclinical safety of ACT, using doses up to 1 mL/kg (3 μL perfluoromethyl-cyclopentane/kg)...
December 2016: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28089783/characterization-of-rat-or-human-hepatocytes-cultured-in-microphysiological-systems-mps-to-identify-hepatotoxicity
#3
Shih-Yu Chang, Jenna L Voellinger, Kirk P Van Ness, Brian Chapron, Rachel M Shaffer, Thomas Neumann, Collin C White, Terrance J Kavanagh, Edward J Kelly, David L Eaton
The liver is the main site for drug and xenobiotics metabolism, including inactivation or bioactivation. In order to improve the predictability of drug safety and efficacy in clinical development, and to facilitate the evaluation of the potential human health effects from exposure to environmental contaminants, there is a critical need to accurately model human organ systems such as the liver in vitro. We are developing a microphysiological system (MPS) based on a new commercial microfluidic platform (Nortis, Inc...
January 12, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/28081501/isolation-characterization-using-lc-esi-qtof-nmr-and-in-vitro-cytotoxicity-assay-of-niclosamide-forced-degradation-products
#4
Johnsirani P, Vishnuvardhan Ch, Lingesh A, Naidu V G M, Naveen Ch, Satheeshkumar N
The present study describes the isolation, characterization and in vitro cytotoxic effect of all forced degradation products of niclosamide (NCM) an anthelmintic class of drug used specifically to treat tapeworms. NCM was subjected to forced degradation involving hydrolysis (acidic, alkaline and neutral), oxidative, photolysis and thermal stress, as per ICH (Q1A (R2)) suggested conditions. The drug under hydrolytic (acidic and basic) conditions showed extensive degradation, while it was stable under neutral hydrolytic, oxidative, photolytic and thermal stress conditions...
January 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28056525/venetoclax
#5
Amber C King, Tim J Peterson, Troy Z Horvat, Mabel Rodriguez, Laura A Tang
OBJECTIVE: To review the pharmacology, efficacy, and safety of venetoclax for treatment of lymphoid malignancies. DATA SOURCES: A literature search was performed of PubMed and MEDLINE databases (2005 to September 2016), abstracts from the American Society of Hematology and the American Society of Clinical Oncology, and ongoing studies from clinicaltrials.gov. Searches were performed utilizing the following key terms: venetoclax, ABT-199, GDC-199, obatoclax, GX15-070, BCL-2 inhibitor, navitoclax, ABT-263, and Venclexta...
December 1, 2016: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28056202/trastuzumab-emtansine-with-or-without-pertuzumab-versus-trastuzumab-plus-taxane-for-human-epidermal-growth-factor-receptor-2-positive-advanced-breast-cancer-primary-results-from-the-phase-iii-marianne-study
#6
Edith A Perez, Carlos Barrios, Wolfgang Eiermann, Masakazu Toi, Young-Hyuck Im, Pierfranco Conte, Miguel Martin, Tadeusz Pienkowski, Xavier Pivot, Howard Burris, Jennifer A Petersen, Sven Stanzel, Alexander Strasak, Monika Patre, Paul Ellis
Purpose Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2) -targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody-drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 demonstrated encouraging efficacy and safety in a phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Combination T-DM1 and pertuzumab showed synergistic activity in cell culture models and had an acceptable safety profile in a phase Ib and II study...
January 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28043557/antimycobacterial-potency-and-cytotoxicity-study-of-three-medicinal-plants
#7
Patrick Valere Tsouh Fokou, Regina Appiah-Opong, Dorothy Yeboah-Manu, Abena Adomah Kissi-Twum, Lauve Rachel Tchokouaha Yamthe, Aristide Laurel Mokale Kognou, Phyllis Addo, Fabrice Fekam Boyom, Alexander Kwadwo Nyarko
OBJECTIVE/BACKGROUND: Mycobacterial infections including tuberculosis, leprosy, and buruli ulcer are among the most prevalent, debilitating, and deadly tropical diseases, especially in Sub-Saharan Africa. The development of drug resistance to the currently available drugs and the poor compliance emphasize the need for new chemotherapeutic agents. This study was designed to evaluate the in vitro activity of Cleistopholis patens, Annona reticulata, and Greenwayodendron suaveolens against Mycobacterium smegmatis...
December 2016: International Journal of Mycobacteriology
https://www.readbyqxmd.com/read/28043556/antimycobacterial-ingredients-from-plants-used-in-traditional-medicine-to-treat-buruli-ulcer
#8
Patrick Valere Tsouh Fokou, Abena Adomah Kissi-Twum, Dorothy Yeboah-Manu, Regina Appiah-Opong, Phyllis Addo, Lauve Rachel Tchokouaha Yamthe, Alvine Ngoutane Mfopa, Fabrice Fekam Boyom, Alexander Kwadwo Nyarko
AIM AND OBJECTIVES: Buruli ulcer (BU) is a neglected tropical disease caused by a mycobacteria, Mycobacterium ulcerans. The WHO recommended Rifampicin-Streptomycin combination side effects and poor compliance, leaves rural populations with no choice than to patronise indigenous remedies. This study is aimed at validating medicinal plants used in traditional medicine to treat BU by investigating the in vitro efficacy and safety as well as their composition in active molecules. METHODS: A short report-based survey was used to identify medicinal plants used traditionally for BU treatment...
December 2016: International Journal of Mycobacteriology
https://www.readbyqxmd.com/read/28042530/enzyme-prodrug-systems-for-cancer-gene-therapy
#9
Obeid M Malekshah, Xuguang Chen, Alireza Nomani, Siddik Sarkar, Arash Hatefi
The use of enzyme/prodrug system has gained attention because it could help improve the efficacy and safety of conventional cancer chemotherapies. In this approach, cancer cells are first transfected with a gene that can express an enzyme with ability to convert a non-toxic prodrug into its active cytotoxic form. As a result, the activated prodrug could kill the transfected cancer cells. Despite the significant progress of different suicide gene therapy protocols in preclinical studies and early clinical trials, none has reached the clinic due to several shortcomings...
December 2016: Current Pharmacology Reports
https://www.readbyqxmd.com/read/28031710/a-quality-by-design-approach-on-polymeric-nanocarrier-delivery-of-gefitinib-formulation-in-vitro-and-in-vivo-characterization
#10
Navya Sree Kola Srinivas, Ruchi Verma, Girish Pai Kulyadi, Lalit Kumar
Gefitinib is an anticancer agent which acts by inhibiting epidermal growth factor receptor tyrosine kinase receptors. The aim of the present study was to prepare gefitinib nanosuspension. Gefitinib was encapsulated in Eudragit(®) RL100 and then dispersed in stabilizer solution, polyvinyl alcohol, and polyvinylpyrrolidone K30. Nanosuspension was prepared by using homogenization and ultrasonication techniques. The quality by design approach was also used in the study to understand the effect of critical material attributes (CMAs) and critical processing parameters (CPPs) on critical quality attributes and to improve the quality and safety of formulation...
2017: International Journal of Nanomedicine
https://www.readbyqxmd.com/read/28027106/systemic-treatment-for-thymic-malignancies
#11
Nicolas Girard, Claire Merveilleux du Vignaux
PURPOSE OF REVIEW: The management of thymic epithelial tumors is a paradigm of multidisciplinary collaboration. Chemotherapy may be administered as part of curative-intent sequential strategy integrating subsequent surgery or radiotherapy, or as an exclusive treatment if local treatment is not achievable. Recurrences of thymic epithelial tumors should be managed according to the same strategy as newly diagnosed tumors. RECENT FINDINGS: More options have become available for advanced, refractory, and recurrent thymic epithelial tumors, which include cytotoxic agents such as carboplatin-paclitaxel, pemetrexed, and oral etoposide...
December 23, 2016: Current Opinion in Oncology
https://www.readbyqxmd.com/read/28024890/assessment-of-cell-viability-and-permeation-enhancement-in-presence-of-lipid-based-self-emulsifying-drug-delivery-systems-using-caco-2-cell-model-polysorbate-80-as-the-surfactant
#12
Pengli Bu, Yue Ji, Silpa Narayanan, Damon Dalrymple, Xingguo Cheng, Abu T M Serajuddin
PURPOSE: Lipid-based self-emulsifying drug delivery systems (SEDDS) are commonly used for solubilizing and enhancing oral bioavailability of poorly water-soluble drugs. However, their effects on viability of intestine epithelial cells and influence on membrane permeation are poorly understood. The present study was undertaken for safety assessment of lipid-based formulations containing medium-chain fatty acid esters as lipids and polysorbate 80 as the surfactant using the Caco-2 in vitro model...
December 24, 2016: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28017859/antiparasitic-activity-of-menadione-vitamin-k3-against-schistosoma-mansoni-in-babl-c-mice
#13
Govind J Kapadia, Ingrid A O Soares, G Subba Rao, Fernanda R Badoco, Ricardo A Furtado, Mariana B Correa, Denise C Tavares, Wilson R Cunha, Lizandra G Magalhães
Schistosomiasis is one of the neglected tropical diseases affecting nearly quarter of a billion people in economically challenged tropical and subtropical countries of the world. Praziquantel (PZQ) is the only drug currently available to treat this parasitic disease in spite being ineffective against juvenile worms and concerns about developing resistance to treat reinfections. Our earlier in vitro viability studies demonstrated significant antiparasitic activity of menadione (MEN) (vitamin K3) against Schistosoma mansoni adult worms...
December 23, 2016: Acta Tropica
https://www.readbyqxmd.com/read/28013349/pharmacology-and-toxicology-of-the-novel-investigational-agent-cantrixil-trx-e-002-1
#14
REVIEW
Muhammad Wasif Saif, Andrew Heaton, Kimberley Lilischkis, James Garner, David M Brown
PURPOSE: Recurrent, chemo-resistant ovarian cancer is thought to be due to a subgroup of slow-growing, drug-resistant cancer cells with stem-like properties and a high capacity for tumour repair. Cantrixil targets this sub-population of cells and is being developed as an intraperitoneal therapy to be used as first-line therapy in combination with carboplatin for epithelial ovarian cancer. The studies presented here justify further development. METHODS: A GLP dog CV study using a 4 × 4 Latin Square Crossover study was conducted using telemetric ECG recordings from dogs post IP administration to assess for cardiac abnormalities...
December 24, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28005456/physicochemical-and-biological-characterization-of-sb2-a-biosimilar-of-remicade%C3%A2-infliximab
#15
Juyong Hong, Yuhwa Lee, Changsoo Lee, Suhyeon Eo, Soyeon Kim, Nayoung Lee, Jongmin Park, Seungkyu Park, Donghyuck Seo, Min Jeong, Youngji Lee, Soojeong Yeon, George Bou-Assaf, Zoran Sosic, Wei Zhang, Orlando Jaquez
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration...
December 22, 2016: MAbs
https://www.readbyqxmd.com/read/27998971/a-phase-i-ii-study-of-cancer-peptide-vaccine-s-288310-in-patients-with-advanced-urothelial-carcinoma-of-the-bladder
#16
W Obara, M Eto, H Mimata, K Kohri, N Mitsuhata, I Miura, T Shuin, T Miki, T Koie, H Fujimoto, K Minami, Y Enomoto, T Nasu, T Yoshida, H Fuse, I Hara, K Kawaguchi, A Arimura, T Fujioka
BACKGROUND: S-288310, a cancer peptide vaccine composed of two HLA-A*24:02-restricted peptides derived from two oncoantigens, DEP domain-containing 1 (DEPDC1) and M-phase phosphoprotein 1 (MPHOSPH1), was investigated in urothelial carcinoma (UC) of the bladder. PATIENTS AND METHODS: Thirty eight HLA-A*24:02-positive patients with progressive UC were enrolled in this study. In the phase I part of the study, three patients each were treated with S-288310 at 1 mg or 2 mg/peptide subcutaneously once a week to evaluate safety and tolerability...
December 20, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/27997919/viability-of-primary-human-pigment-epithelium-cells-and-muller-glia-cells-after-intravitreal-ziv-aflibercept-and-aflibercept
#17
Gabriel Costa de Andrade, Christian Wertheimer, Kirsten Eibl, Armin Wolf, Anselm Kampik, Eduardo Buchele Rodrigues, Michel Eid Farah, Christos Haritoglou
PURPOSE: The aim of this study was to access the safety profiles of 2 fusion proteins with anti-vascular endothelial growth factor action (ziv-aflibercept and aflibercept) on retinal pigment epithelium cells and Muller-Glia cells in culture by assessing cell viability post drug exposure. METHODS: Primary human retinal pigment epithelium cells (pRPE) and Muller-Glia cells (Mio-M1) were exposed to the clinical standardized concentrations of ziv-aflibercept (25 mg/mL) and aflibercept (40 mg/mL)...
2016: Ophthalmologica. Journal International D'ophtalmologie
https://www.readbyqxmd.com/read/27988360/targeted-delivery-for-regenerative-medicines-an-untapped-opportunity-for-drug-conjugates
#18
Eric Valeur, Laurent Knerr, Maria Ölwegård-Halvarsson, Malin Lemurell
Regenerative approaches are promising avenues to effectively cure diseases rather than merely treating symptoms, but are associated with concerns around proliferation in other organs. Given that targeted delivery holds the promise of delivering a drug precisely to its desired site of action, usually with the prospect of increasing the therapeutic index, it can be considered as an essential enabler of regenerative medicines. Although significant progress has been made predominantly in oncology for the delivery of cytotoxic drugs using antibody-drug conjugates (ADCs), the physiological conditions and safety requirements for regenerative medicines are very different...
December 14, 2016: Drug Discovery Today
https://www.readbyqxmd.com/read/27982602/targeted-biomimetic-nanoparticles-for-synergistic-combination-chemotherapy-of-paclitaxel-and-doxorubicin
#19
Mengjie Rui, Yuanrong Xin, Ran Li, Yanru Ge, Chunlai Feng, Ximing Xu
Codelivery of multiple chemotherapeutics has become a versatile strategy in recent cancer treatment, but the antagonistic behavior of combined drugs limited their application. We developed a recombinant high-density lipoprotein (rHDL) nanoparticle for the precise coencapsulation and codelivery of two established drugs and hypothesized that they could act synergistically to improve anticancer efficacy. The coloaded rHDL was formulated by passively incorporating hydrophobic paclitaxel (PTX), and subsequently remotely loading hydrophilic doxorubicin (Dox) into the same nanoparticles...
January 3, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/27974925/new-pharmacological-strategies-in-rheumatic-diseases
#20
REVIEW
Schiotis Re, Buzoianu Ad, Mureșanu Df, Suciu S
Targeting the pathogenic pathway of chronic inflammation represents an unmet challenge for controlling disease activity, preventing functional disability, and maintaining an adequate quality of life in patients with rheumatic diseases. Abatacept, a novel molecule that inhibits co-stimulation signal, induces an inhibitory effect on the T-cells. This will further interfere with the activity of several cell lines, leading to the normalization of the immune response. In the latest years, abatacept has been extensively investigated in studies of rheumatoid arthritis for which it was recently approved as a second line biologic treatment in Romania...
July 2016: Journal of Medicine and Life
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