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https://www.readbyqxmd.com/read/28322893/in-vitro-and-in-vivo-safety-evaluation-of-nephure%C3%A2
#1
Helena Cowley, Qin Yan, Lee Koetzner, Laurie Dolan, Erik Nordwald, Aaron B Cowley
Nephure™ is a proprietary oxalate decarboxylase (OxDC) enzyme being developed as a food ingredient. In this study, the safety of Nephure™ was evaluated in a bacterial mutagenicity assay and in a sub-chronic (13-week) oral toxicity study in rats. Nephure™ did not show any mutagenic properties in the mutagenicity assay. In the 13-week sub-chronic oral toxicity study in which 10 Sprague Dawley rats per sex were administered 0, 118, 235 and 475 mg/kg bw/day (8260, 16450 and 33,250 Units/kg bw/day, respectively) of Nephure™ by gavage, male and female rats did not show any test article-related clinical observations or effects on body weight, body weight gain, food consumption, food efficiency, ophthalmology, functional observational battery parameters or motor activity...
March 18, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28287415/dietary-buglossoides-arvensis-oil-increases-circulating-n-3-polyunsaturated-fatty-acids-in-a-dose-dependent-manner-and-enhances-lipopolysaccharide-stimulated-whole-blood-interleukin-10-a-randomized-placebo-controlled-trial
#2
Natalie Lefort, Rémi LeBlanc, Marc E Surette
Buglossoides arvensis (Ahiflower) oil is a dietary oil rich in stearidonic acid (20% SDA; 18:4 n-3). The present randomized, double blind, placebo-controlled clinical trial investigated the effects of three Ahiflower oil dosages on omega-3 polyunsaturated fatty acid (PUFA) content of plasma and mononuclear cells (MCs) and of the highest Ahiflower dosage on stimulated cytokine production in blood. Healthy subjects (n = 88) consumed 9.7 mL per day for 28 days of 100% high oleic sunflower oil (HOSO); 30% Ahiflower oil (Ahi) + 70% HOSO; 60% Ahi + 40% HOSO; and 100% Ahi...
March 10, 2017: Nutrients
https://www.readbyqxmd.com/read/28265009/preclinical-mammalian-safety-studies-of-epharna-dopc-nanoliposomal-epha2-targeted-sirna
#3
Michael J Wagner, Rahul Mitra, Mark J McArthur, Wallace Baze, Kirstin Barnhart, Sherry Wu, Cristian Rodriguez-Aguayo, Xinna Zhang, Robert L Coleman, Gabriel Lopez-Berestein, Anil K Sood
To address the need for efficient and biocompatible delivery systems for systemic siRNA delivery, we developed 1,2-Dioleoyl-sn-Glycero-3-Phosphatidylcholine (DOPC) nanoliposomal EphA2-targeted therapeutic (EPHARNA). Here, we performed safety studies of EPHARNA in murine and primate models. Single dosing of EPHARNA was tested at 5 concentrations in mice (N=15 per group) and groups were sacrificed on days 1, 14, and 28 for evaluation of clinical pathology and organ toxicity. Multiple dosing of EPHARNA was tested in mice and Rhesus macaques twice weekly at two dose levels in each model...
March 6, 2017: Molecular Cancer Therapeutics
https://www.readbyqxmd.com/read/28249303/clinical-parameters-following-multiple-oral-dose-administration-of-a-standardized-andrographis-paniculata-capsule-in-healthy-thai-subjects
#4
Tawit Suriyo, Nanthanit Pholphana, Teerapat Ungtrakul, Nuchanart Rangkadilok, Duangchit Panomvana, Apinya Thiantanawat, Wanwisa Pongpun, Jutamaad Satayavivad
Andrographis paniculata has been widely used in Scandinavian and Asian counties for the treatment of the common cold, fever, and noninfectious diarrhea. The present study was carried out to investigate the physiological effects of short-term multiple dose administration of a standardized A. paniculata capsule used for treatment of the common cold and uncomplicated upper respiratory tract infections, including blood pressure, electrocardiogram, blood chemistry, hematological profiles, urinalysis, and blood coagulation in healthy Thai subjects...
March 1, 2017: Planta Medica
https://www.readbyqxmd.com/read/28214195/first-clinical-case-of-canine-granulocytic-anaplasmosis-in-korea-and-genotypic-analyses-of-anaplasma-phagocytophilum
#5
Seung-Hun Lee, Nara Kim, Dongmi Kwak
A 2-year-old male Jindo dog was presented to a local veterinary clinic for anorexia, lethargy, edema around neck, and vomiting. Based on the clinical history, physical examination, hematology, blood chemistry, serology, and PCR, the dog was diagnosed with canine granulocytic anaplasmosis (CGA). PCR and phylogenetic analyses targeting the 16S rRNA, groEL, and msp2 genes of Anaplasma phagocytophilum revealed that the A. phagocytophilum identified in this study subgrouped into alanine and USA groups according to the groEL and msp2 gene sequences, respectively...
February 3, 2017: Ticks and Tick-borne Diseases
https://www.readbyqxmd.com/read/28181678/safety-and-immunological-efficacy-of-a-dna-vaccine-encoding-the-androgen-receptor-ligand-binding-domain-ar-lbd
#6
Brian M Olson, Eric S Bradley, Thomas Sawicki, Weixiong Zhong, Erik A Ranheim, Jordan E Bloom, Viswa T Colluru, Laura E Johnson, Brian T Rekoske, Jens C Eickhoff, Douglas G McNeel
BACKGROUND: The androgen receptor (AR) is a key oncogenic driver of prostate cancer, and has been the primary focus of prostate cancer treatment for several decades. We have previously demonstrated that the AR is also an immunological target antigen, recognized in patients with prostate cancer, and targetable by means of vaccines in rodent models with delays in prostate tumor growth. The current study was performed to determine the safety and immunological efficacy of a GMP-grade plasmid DNA vaccine encoding the ligand-binding domain (LBD) of the AR, pTVG-AR...
February 9, 2017: Prostate
https://www.readbyqxmd.com/read/28166521/rationale-and-design-of-a-clinical-trial-investigating-tolvaptan-safety-and-efficacy-in-autosomal-dominant-polycystic-kidney-disease
#7
Vicente E Torres, Olivier Devuyst, Arlene B Chapman, Ron T Gansevoort, Ronald D Perrone, John Ouyang, Jaime D Blais, Frank S Czerwiec, Olga Sergeyeva
BACKGROUND: In TEMPO 3:4, the vasopressin V2-receptor antagonist tolvaptan slowed kidney growth and function decline in autosomal dominant polycystic kidney disease (ADPKD) patients with relatively preserved kidney function. METHODS: Prospective, phase 3b, multi-center, randomized-withdrawal, placebo-controlled, double-blind trial of tolvaptan in ADPKD patients with late stage 2 to early stage 4 chronic kidney disease (CKD). The primary endpoint was estimated glomerular filtration rate (eGFR) change from pre-treatment baseline to post-treatment follow-up...
2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28164761/mitogen-activated-protein-kinase-mapk-interacting-kinases-1-and-2-mnk1-and-mnk2-as-targets-for-cancer-therapy-recent-progress-in-the-development-of-mnk-inhibitors
#8
Agnieszka Dreas, Maciej Mikulski, Mariusz Milik, Charles-Henry Fabritius, Krzysztof Brzózka, Tomasz Rzymski
BACKGROUND: MNK1 and MNK2 are MAP kinase-interacting serine/threonine kinases, which are activated by RAS and MAPK signaling pathways and are involved in regulation of protein translation. Both kinases phosphorylate translation initiation factor eIF4E on a conserved serine 209. Overactivated eIF4E can act as an oncogene and contribute to the transformation both in vitro and in vivo and is highly expressed in diverse types of cancer. Interestingly, knockout mice that lack both Mnk1 and Mnk2 do not have any apparent phenotype...
February 3, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28161122/acute-and-repeated-dose-28-days-toxicity-studies-in-rats-and-dogs-of-recombinant-batroxobin-a-snake-venom-thrombin-like-enzyme-expressed-from-pichia-pastoris
#9
Ok Hwan Kim, Kil-Sang Cho, Young Seomun, Jong-Tak Kim, Kwang-Hoe Chung
Recombinant batroxobin is a thrombin-like enzyme of Bothrops atrox moojeni venom. To evaluate its toxicological effect, it was highly expressed in Pichia pastorisand successfully purified to homogeneity from culture broth supernatant following Good Manufacturing Practice (GMP). The maximum tolerated dose of the recombinant batroxobin was examined in Sprague-Dawley (SD) rat and Beagle dogs following Good Laboratory Practice (GLP) regulations. The approximate lethal dose of recombinant batroxobin was 10 National Institute of Health (NIH) u/kg in male and female rats...
February 1, 2017: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/28153367/using-sigma-quality-control-to-verify-and-monitor-performance-in-a-multi-instrument-multisite-integrated-health-care-network
#10
REVIEW
Harold H Harrison, Jay B Jones
The authors developed a system-wide integrated network of instrumentation and Sigma-based quality control for fundamental chemistry, coagulation, and hematology analysis. The authors have based selection of Westgard rules for run management on a straightforward, Sigma-driven selection process. The network includes multiple hospitals and large regional clinic laboratories. Most hospitals have multiple instruments; overall there are at least four distinct instrument models active from each manufacturer. The authors have measured and monitored Sigma values in this network for more than five years, to verify and validate performance and to provide ongoing justification for rules selection and rules changes when necessary...
March 2017: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/28149266/national-external-quality-assurance-program-pakistan-neqapp-a-milestone-in-proficiency-testing-in-pakistan
#11
Muhammad Usman Munir, Aamir Ijaz
OBJECTIVE: The objective of this study was to highlight current status and importance of National External Quality Assurance Program Pakistan (NEQAPP). Study Design: Cross sectional study. PLACE AND DURATION OF STUDY: Department of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology (AFIP) from August to October 2015. METHODS: The study data was extracted from electronic NEQAPP database. Results from 2014-2015 were evaluated for clinical chemistry, hematology, microbiology, and immunoassay programs...
December 2016: EJIFCC
https://www.readbyqxmd.com/read/28138994/megakaryocyte-expansion-and-macrophage-infiltration-in-bone-marrow-of-rats-subchronically-treated-with-mnx-n-nitroso-environmental-degradation-product-of-munitions-compound-rdx-hexahydro-1-3-5-trinitro-1-3-5-triazine
#12
Sindhura Ramasahayam, Sridhar Jaligama, Sahar M Atwa, Joshua T Salley, Marissa Thongdy, Benny L Blaylock, Sharon A Meyer
Hexahydro-1-nitroso-3,5-dinitro-1,3,5-triazine (MNX), environmental degradation product of munitions hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX), causes seizures in rats with acute oral exposure like parent RDX. Our previous studies have additionally reported hematotoxicity with acute MNX exposure manifested as myelosuppression, anemia and splenic hemosiderosis. This study explored whether MNX administered subchronically continued to target bone marrow to elicit peripheral blood cytopenia. Female Sprague-Dawley rats were gavaged daily for 4 or 6 weeks with 47 mg kg(-1)  day(-1) MNX (¼ LD50 ) or vehicle (5% dimethyl sulfoxide in corn oil) and hematological and clinical chemistry parameters, spleen weights, spleen and bone marrow histopathology and immunohistochemistry with ED1 anti-CD68 macrophage marker were evaluated 24 h after the last dose...
January 31, 2017: Journal of Applied Toxicology: JAT
https://www.readbyqxmd.com/read/28135891/successful-treatment-of-hypersplenism-in-wilson-s-disease-by-partial-splenic-embolization
#13
Liang-Yong Li, Huai-Zhen Chen, Yuan-Cheng Bao, Qing-Sheng Yu, Wen-Ming Yang
AIM: Hypersplenism can occur in patients with Wilson's disease (WD). Surgical splenectomy is a conventional treatment for this condition; however, emotional and neurological deterioration may follow splenectomy. In recent years, partial splenic embolization (PSE) has been increasingly performed as a nonsurgical alternative treatment for hypersplenism. The aim of this study was to evaluate the effectiveness and safety of PSE compared with splenectomy in the treatment of hypersplenism in WD patients...
January 31, 2017: Journal of Investigative Surgery: the Official Journal of the Academy of Surgical Research
https://www.readbyqxmd.com/read/28133509/subchronic-oral-toxicity-study-of-acanthopanax-divaricatus-var-albeofructus-in-rats
#14
Myoung Jun Kim, Mi Ju Lee, Yong-Hoon Lee, Sun Hee Park, Duyeol Kim, Cheol Beom Park, Jin Seok Kang, Jong-Koo Kang
Acanthopanax divaricatus (Siebold & Zucc.) Seem. var. albeofructus (ADA), a traditional medical herb, has been used to treat arthritis and muscular injury, to strengthen muscle and bone, and to get vital energy. However, information regarding its toxicity is limited. ADA was administered by oral gavage to groups of rats at doses of 0 (control), 1,000, 1,500, 2,000, 2,500, and 3,000 mg/kg five times per week for 13 weeks. Mortality, clinical signs, body weights, food consumption, hematology, serum chemistry, urinalysis, organ weights, necropsy, histopathological finding, vaginal cytology, and sperm morphology were compared between control and ADA-treated groups...
January 2017: Toxicological Research
https://www.readbyqxmd.com/read/28132846/a-90-day-toxicity-study-of-gmtmt-transgenic-maize-in-sprague-dawley-rats
#15
Jin Fang, Yongquan Feng, Yuan Zhi, Lan Zhang, Zhou Yu, Xudong Jia
GmTMT transgenic maize is a genetically modified maize plant that overexpresses the γ-tocopherol methyltransferase (γ-TMT) from Glycine max (Gm). The γ-TMT gene was introduced into maize line Zhen58 to encode the GmTMT2a protein which can convert γ-tocopherol into α-tocopherol. Overexpression of GmTMT2a significantly increased the α-tocopherol content in transgenic maize. The present study was designed to investigate any potential effects of GmTMT maize grain in a 90-day subchronic rodent feeding study...
January 27, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28110321/recent-advances-in-arsenic-trioxide-encapsulated-nanoparticles-as-drug-delivery-agents-to-solid-cancers
#16
Akhtar Anam, Wang Scarlet Xiaoyan, Ghali Lucy, Bell Celia, Wen Xuesong
Since arsenic trioxide was first approved as the front line therapy for acute promyelocytic leukemia 25 years ago, its anti-cancer properties for various malignancies have been under intense investigation. However, the clinical successes of arsenic trioxide in treating hematological cancers have not been translated to solid cancers. This is due to arsenic's rapid clearance by the body's immune system before reaching the tumor site. Several attempts have henceforth been made to increase its bioavailability toward solid cancers without increasing its dosage albeit without much success...
January 19, 2017: Journal of Biomedical Research
https://www.readbyqxmd.com/read/28097044/study-on-the-single-dose-toxicity-of-shineumhur-pharmacopuncture-injected-into-the-muscles-of-rats
#17
Hohyun Jeong, Eunhye Cha, Jongcheol Lee, Seongjin Lee, Manyong Park, Dongwoung Kim, Bongkeun Song, Jongdeok Lee, Sungchul Kim
OBJECTIVES: This study was carried out to analyze the single dose toxicity of ShinEumHur (SEH) pharmacopuncture injected into the muscles of Sprague-Dawley rats. METHODS: The SEH pharmacopuncture was made in a clean room at the Korean Pharmacopuncture Institute (K-GMP). After the mixing process with sterile distilled water had been completed, the pH was controlled to between 7.0 and 7.5. All experiments were conducted at Biotoxtech, an institution authorized to perform non-clinical studies under the Good Laboratory Practice (GLP) regulations...
December 2016: Journal of Pharmacopuncture
https://www.readbyqxmd.com/read/28072712/seniorlab-a-prospective-observational-study-investigating-laboratory-parameters-and-their-reference-intervals-in-the-elderly
#18
Martin Risch, Urs Nydegger, Lorenz Risch
BACKGROUND: In clinical practice, laboratory results are often important for making diagnostic, therapeutic, and prognostic decisions. Interpreting individual results relies on accurate reference intervals and decision limits. Despite the considerable amount of resources in clinical medicine spent on elderly patients, accurate reference intervals for the elderly are rarely available. The SENIORLAB study set out to determine reference intervals in the elderly by investigating a large variety of laboratory parameters in clinical chemistry, hematology, and immunology...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28070107/effects-of-reduced-food-intake-for-4-weeks-on-physiological-parameters-in-toxicity-studies-in-dogs
#19
Junya Morita, Tomoko Izumi, Bunichiro Ogawa, Yoshiki Ban, Hironori Takagi, Minoru Sasaki, Shunsuke Tsutsumi
This study sought to clarify the effects of reduced feeding on physiological parameters in dogs to enable appropriate evaluations of the safety and toxicity of test compounds. We measured alkaline phosphatase isozymes and the circulating blood volume, as well as clinical signs, body weight, hematology, blood chemistry, electrocardiography, organ weight, and histopathology, in male beagle dogs fed a diet consisting of 300 g/day or 150 g/day for 4 weeks. There were no abnormal clinical signs in any of the dogs...
2017: Journal of Toxicological Sciences
https://www.readbyqxmd.com/read/28065395/serial-retrograde-instillations-of-sustained-release-formulation-of-mitomycin-c-to-the-upper-urinary-tract-of-the-yorkshire-swine-using-a-thermosensitive-polymer-safety-and-feasibility
#20
Nicholas M Donin, Dalit Strauss-Ayali, Yael Agmon-Gerstein, Nadav Malchi, Andrew T Lenis, Stuart Holden, Allan J Pantuck, Arie S Belldegrun, Karim Chamie
BACKGROUND: MitoGel is a novel drug formulation intended for the treatment of upper tract urothelial cancer with proven feasibility and safety in an animal model. OBJECTIVE: To evaluate the feasibility, safety, toxicokinetics, and histologic changes associated with serial retrograde MitoGel instillations to the upper urinary tract in a swine model. DESIGN, SETTING, AND PARTICIPANTS: Overall, 27 Yorkshire swine underwent 6 once-weekly unilateral retrograde instillations of MitoGel...
January 3, 2017: Urologic Oncology
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