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https://www.readbyqxmd.com/read/28642891/safety-tolerability-of-the-anti-semaphorin-4d-antibody-vx15-2503-in-a-randomized-phase-1-trial
#1
Christopher LaGanke, Lawrence Samkoff, Keith Edwards, Lily Jung Henson, Pavle Repovic, Sharon Lynch, Lael Stone, David Mattson, Aaron Galluzzi, Terrence L Fisher, Christine Reilly, Laurie A Winter, John E Leonard, Maurice Zauderer
OBJECTIVE: To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX15/2503 in a randomized, single-dose, dose-escalation, double-blind, placebo-controlled study enrolling adult patients with MS. METHODS: Single IV doses of VX15/2503 or placebo were administered. Ten patients each were randomized (4:1 randomization ratio) into 5 ascending dose cohorts of 1, 3, 6, 10, or 20 mg/kg. Safety, immunogenicity, PK/PD, MRI, ECG, and lymphocyte subset levels were evaluated...
July 2017: Neurology® Neuroimmunology & Neuroinflammation
https://www.readbyqxmd.com/read/28635620/anomalous-dielectric-response-of-short-hydrogen-bonds-under-pressure-the-case-of-mn-fe-sup-2-sup-alpo-sub-4-sub-oh-sub-2-sub-h-sub-2-sub-o
#2
Benedikt Röska, So-Hyun Park, Yusuke Yoshimori, Kenta Kimura, Tsuyoshi Kimura
An anomalous increase in the real part of dielectric response is observed in Mn<sub>0.5</sub>Fe<sub>0.5</sub>AlPO<sub>4</sub>(OH)<sub>2</sub>H<sub>2</sub>O while cooling to ~70 K. This is addressed to field-induced proton dynamics in a short hydrogen bond of 2.480(3) Å. The absence of discontinuities in heat capacity curves above the Néel temperature (T<sub>N</sub> ≈ 7 K) excludes a paraelectric to antiferroelectric phase transition...
June 21, 2017: Journal of Physics. Condensed Matter: An Institute of Physics Journal
https://www.readbyqxmd.com/read/28630677/non-lamellar-lipid-assembly-at-interfaces-controlling-layer-structure-by-responsive-nanogel-particles
#3
Aleksandra P Dabkowska, Maria Valldeperas, Christopher Hirst, Costanza Montis, Gunnar K Pálsson, Meina Wang, Sofi Nöjd, Luigi Gentile, Justas Barauskas, Nina-Juliane Steinke, Gerd E Schroeder-Turk, Sebastian George, Maximilian W A Skoda, Tommy Nylander
Biological membranes do not only occur as planar bilayer structures, but depending on the lipid composition, can also curve into intriguing three-dimensional structures. In order to fully understand the biological implications as well as to reveal the full potential for applications, e.g. for drug delivery and other biomedical devices, of such structures, well-defined model systems are required. Here, we discuss the formation of lipid non-lamellar liquid crystalline (LC) surface layers spin-coated from the constituting lipids followed by hydration of the lipid layer...
August 6, 2017: Interface Focus
https://www.readbyqxmd.com/read/28629912/calprotectin-and-the-magnitude-of-antibodies-to-infliximab-in-clinically-stable-ulcerative-colitis-patients-are-more-relevant-than-infliximab-trough-levels-and-pharmacokinetics-for-therapeutic-escalation
#4
Fernando Magro, Joana Afonso, Susana Lopes, Rosa Coelho, Raquel Gonçalves, Paulo Caldeira, Paula Lago, Helena Tavares de Sousa, Jaime Ramos, Ana Rita Gonçalves, Paula Ministro, Isadora Rosa, Ana Isabel Vieira, Patrícia Andrade, João-Bruno Soares, Diana Carvalho, Paula Sousa, Tânia Meira, Joanne Lopes, Joana Moleiro, Cláudia Camila Dias, Amílcar Falcão, Karel Geboes, Fatima Carneiro
Although infliximab (IFX) is an efficient therapy for ulcerative colitis (UC) patients, a considerably high rate of therapeutic failures still occurs. This study aimed at a better understanding of IFX pharmacokinetics and pharmacodynamics among clinically-asymptomatic UC patients. This was a multicentric and prospective study involving 65 UC patients in the maintenance phase of IFX therapy. There were no significant differences between patients with positive and negative clinical, endoscopic and histological outcomes concerning their IFX trough levels (TLs), area under the IFX concentration vs...
June 7, 2017: EBioMedicine
https://www.readbyqxmd.com/read/28619227/efficacy-and-safety-of-praziquantel-in-preschool-aged-and-school-aged-children-infected-with-schistosoma-mansoni-a-randomised-controlled-parallel-group-dose-ranging-phase-2-trial
#5
Jean T Coulibaly, Gordana Panic, Kigbafori D Silué, Jana Kovač, Jan Hattendorf, Jennifer Keiser
BACKGROUND: Praziquantel has been the drug of choice for schistosomiasis control for more than 40 years, yet surprisingly, the optimal dose for children younger than 4 years is not known. We aimed to assess the efficacy and safety of escalating praziquantel dosages in preschool-aged children (PSAC). METHODS: We did a randomised controlled, parallel-group, single-blind, dose-ranging, phase 2 trial in PSAC (2-5 years) and school-aged children (SAC; aged 6-15 years) as a comparator group in southern Côte d'Ivoire...
July 2017: Lancet Global Health
https://www.readbyqxmd.com/read/28618595/anticipated-synchronization-in-neuronal-circuits-unveiled-by-a-phase-response-curve-analysis
#6
Fernanda S Matias, Pedro V Carelli, Claudio R Mirasso, Mauro Copelli
Anticipated synchronization (AS) is a counterintuitive behavior that has been observed in several systems. When AS occurs in a sender-receiver configuration, the latter can predict the future dynamics of the former for certain parameter values. In particular, in neuroscience AS was proposed to explain the apparent discrepancy between information flow and time lag in the cortical activity recorded in monkeys. Despite its success, a clear understanding of the mechanisms yielding AS in neuronal circuits is still missing...
May 2017: Physical Review. E
https://www.readbyqxmd.com/read/28618541/qualitative-changes-in-phase-response-curve-and-synchronization-at-the-saddle-node-loop-bifurcation
#7
Janina Hesse, Jan-Hendrik Schleimer, Susanne Schreiber
Prominent changes in neuronal dynamics have previously been attributed to a specific switch in onset bifurcation, the Bogdanov-Takens (BT) point. This study unveils another, relevant and so far underestimated transition point: the saddle-node-loop bifurcation, which can be reached by several parameters, including capacitance, leak conductance, and temperature. This bifurcation turns out to induce even more drastic changes in synchronization than the BT transition. This result arises from a direct effect of the saddle-node-loop bifurcation on the limit cycle and hence spike dynamics...
May 2017: Physical Review. E
https://www.readbyqxmd.com/read/28612409/self-assembled-pd-ceo2-%C3%AE-al2-o3-catalysts-with-enhanced-activity-for-catalytic-methane-combustion
#8
Xilan Feng, Wang Li, Dapeng Liu, Zheng Zhang, Yang Duan, Yu Zhang
Pd@CeO2 /Al2 O3 catalysts are of great importance for real applications, such as three-way catalysis, CO oxidation, and methane combustion. In this article, the Pd@CeO2 core@shell nanospheres are prepared via the autoredox reaction in aqueous phase. Three kinds of methods are then employed, that is, electrostatic interaction, supramolecular self-assembly, and physical mixing, to support the as-prepared Pd@CeO2 nanospheres on γ-Al2 O3 . A model reaction of catalytic methane-combustion is employed here to evaluate the three Pd@CeO2 /γ-Al2 O3 samples...
June 14, 2017: Small
https://www.readbyqxmd.com/read/28609389/time-to-first-occurrence-of-breast-pain-and-vaginal-bleeding-in-phase-3-trials-of-ce-bza
#9
JoAnn V Pinkerton, Andrew G Bushmakin, Joel Bobula, Joanne Lavenberg, Barry S Komm, Lucy Abraham
OBJECTIVE: In studies of the menopausal therapy, conjugated estrogens/bazedoxifene, breast pain and vaginal bleeding rates were comparable to placebo and lower than conjugated estrogens/medroxyprogesterone acetate (MPA). This post hoc analysis determined median time to occurrence of these events. METHODS: Participants in phase 3 conjugated estrogens/bazedoxifene trials recorded breast pain and vaginal bleeding in daily diaries. Median time to first incident was determined in women taking conjugated estrogens 0...
June 12, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28606766/medicinal-species-as-mtdls-turnera-diffusa-willd-ex-schult-inhibits-cns-enzymes-and-delays-glutamate-excitotoxicity-in-sh-sy5y-cells-via-oxidative-damage
#10
João Bernardo, Federico Ferreres, Ángel Gil-Izquierdo, Patrícia Valentão, Paula B Andrade
One of the most promising approaches to confront the complexity of central nervous system disorders are new multi-target directed ligands (MTDLs). Five medicinal species (Cereus grandiflorus (L.) Mill., Hyssopus officinalis L., Acorus calamus L., Silybum marianum L. Gaertn. and Turnera diffusa Willd. Ex Schult), selected for their ethnopharmacological relevance, were object for in vitro screening. The aqueous extract of T. diffusa revealed the strongest neuroactive potential, inhibiting monoamine oxidase-A (IC50 = 129...
June 9, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28605625/high-stability-of-the-immunomodulatory-gk-1-synthetic-peptide-measured-by-a-reversed-phase-high-performance-liquid-chromatography-method
#11
Jacquelynne Cervantes-Torres, René Segura-Velázquez, Patricia Padilla, Edda Sciutto, Gladis Fragoso
The 18-mer anionic peptide GK-1 has been successfully employed to improve the immunogenicity and protective response induced by the influenza vaccine and exhibited some degree of protection against experimental murine melanoma. In this study, a sensitive and quantitative reversed-phase HPLC method was developed to study GK-1 stability under different pH, temperature and storage time. The analysis was carried out on a Sunfire C18 column with mobile phase of acetonitrile-water containing 0.02% TFA. The detection was performed on an UV/Vis Detector at 220nm...
June 4, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28599432/efficacy-and-tolerability-of-nanoparticle-albumin-bound-paclitaxel-in-combination-with-carboplatin-as-a-late-phase-chemotherapy-for-recurrent-and-advanced-non-small-cell-lung-cancer-a-multi-center-study-of-the-fukushima-lung-cancer-association-group-of-surgeons
#12
Mitsunori Higuchi, Hironori Takagi, Yuki Owada, Takuya Inoue, Yuzuru Watanabe, Takumi Yamaura, Mitsuro Fukuhara, Satoshi Muto, Naoyuki Okabe, Yuki Matsumura, Takeo Hasegawa, Atsushi Yonechi, Jun Osugi, Mika Hoshino, Yutaka Shio, Koichi Fujiu, Ryuzo Kanno, Akio Ohishi, Hiroyuki Suzuki, Mitsukazu Gotoh
The present retrospective multi-center study aimed to evaluate the efficacy and feasibility of nanoparticle albumin-bound (nab)-paclitaxel plus carboplatin as a second or late-phase chemotherapy in patients with non-small cell lung cancer (NSCLC). A total of 25 patients with recurrent or advanced NSCLC who had received previous chemotherapy were treated with nab-paclitaxel (70-100 mg/m(2), intravenously) on days 1, 8 and 15 every 28 days with a carboplatin area under the concentration-time curve of 4-6 on day 1...
June 2017: Oncology Letters
https://www.readbyqxmd.com/read/28595616/phase-i-study-of-oral-ridaforolimus-in-combination-with-paclitaxel-and-carboplatin-in-patients-with-solid-tumor-cancers
#13
Hye Sook Chon, Sokbom Kang, Jae K Lee, Sachin M Apte, Mian M Shahzad, Irene Williams-Elson, Robert M Wenham
BACKGROUND: Ridaforolimus is a mammalian target of rapamycin inhibitor that has activity in solid tumors. Paclitaxel and carboplatin have broad antineoplastic activity in many cancers. This phase I trial was conducted to determine the safety profile, maximal tolerated dose, and recommended phase II dose and schedule of oral ridaforolimus combined with paclitaxel and carboplatin in patients with solid tumor cancers. METHODS: Eligible patients with advanced solid tumor cancers received oral 10 to 30 mg ridaforolimus daily for 5 consecutive days per week combined with intravenous paclitaxel (175 mg/m(2)) and carboplatin (area under the curve [AUC] 5-6 mg/mL/min) in 3-week cycles...
June 8, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28591833/a-new-fully-human-recombinant-fsh-follitropin-epsilon-two-phase-i-randomized-placebo-and-comparator-controlled-pharmacokinetic-and-pharmacodynamic-trials
#14
Khalid Abd-Elaziz, Ingrid Duijkers, Lars Stöckl, Bruno Dietrich, Christine Klipping, Kelvin Eckert, Steffen Goletz
STUDY QUESTION: What are the differences and similarities of pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the novel recombinant human FSH follitropin epsilon expressed in the human cell line GlycoExpress compared with a Chinese hamster ovary (CHO) derived compound and a urinary derived product? SUMMARY ANSWER: Overall follitropin epsilon, with a fully human glycosylation, shows a comparable PK profile at single-dose as well as multiple-dose administration compared to recombinant CHO-derived FSH as well as urinary derived FSH, whereas the PD properties differ from product to product with follitropin epsilon being most active in PD parameters...
June 7, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28577419/a-simplified-guide-for-charged-aerosol-detection-of-non-chromophoric-compounds-analytical-method-development-and-validation-for-the-hplc-assay-of-aerosol-particle-size-distribution-for-amikacin
#15
Arianne Soliven, Imad A Haidar Ahmad, James Tam, Nani Kadrichu, Pete Challoner, Robert Markovich, Andrei Blasko
Amikacin, an aminoglycoside antibiotic lacking a UV chromophore, was developed into a drug product for delivery by inhalation. A robust method for amikacin assay analysis and aerosol particle size distribution (aPSD) determination, with comparable performance to the conventional UV detector was developed using a charged aerosol detector (CAD). The CAD approach involved more parameters for optimization than UV detection due to its sensitivity to trace impurities, non-linear response and narrow dynamic range of signal versus concentration...
May 31, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28574931/neoadjuvant-weekly-paclitaxel-carboplatin-is-effective-in-stage-i-ii-cervical-cancer
#16
Rawand Salihi, Karin Leunen, Philippe Moerman, Frédéric Amant, Patrick Neven, Ignace Vergote
OBJECTIVE: Neoadjuvant chemotherapy (NACT) followed by surgery in cervical cancer is widely studied with paclitaxel-ifosfamide-cisplatinum 3 weekly (TIP). Although the response rates with TIP are high, the toxicity is substantial. Therefore, this study evaluates dose-dense paclitaxel-carboplatin (TC) as an alternative. METHODS: In this prospective phase 2 study trial, we included 36 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB1 to IIB cervical cancer, who received 9 weeks' NACT dose-dense TC (median weekly dose paclitaxel 60 mg/m, carboplatinum area under the curve 2...
June 1, 2017: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/28569367/resonance-modulation-annihilation-and-generation-of-anti-resonance-and-anti-phasonance-in-3d-neuronal-systems-interplay-of-resonant-and-amplifying-currents-with-slow-dynamics
#17
Horacio G Rotstein
Subthreshold (membrane potential) resonance and phasonance (preferred amplitude and zero-phase responses to oscillatory inputs) in single neurons arise from the interaction between positive and negative feedback effects provided by relatively fast amplifying currents and slower resonant currents. In 2D neuronal systems, amplifying currents are required to be slave to voltage (instantaneously fast) for these phenomena to occur. In higher dimensional systems, additional currents operating at various effective time scales may modulate and annihilate existing resonances and generate antiresonance (minimum amplitude response) and antiphasonance (zero-phase response with phase monotonic properties opposite to phasonance)...
May 31, 2017: Journal of Computational Neuroscience
https://www.readbyqxmd.com/read/28562223/effect-of-phase-response-curve-shape-and-synaptic-driving-force-on-synchronization-of-coupled-neuronal-oscillators
#18
Ramana Dodla, Charles J Wilson
The role of the phase response curve (PRC) shape on the synchrony of synaptically coupled oscillating neurons is examined. If the PRC is independent of the phase, because of the synaptic form of the coupling, synchrony is found to be stable for both excitatory and inhibitory coupling at all rates, whereas the antisynchrony becomes stable at low rates. A faster synaptic rise helps extend the stability of antisynchrony to higher rates. If the PRC is not constant but has a profile like that of a leaky integrate-and-fire model, then, in contrast to the earlier reports that did not include the voltage effects, mutual excitation could lead to stable synchrony provided the synaptic reversal potential is below the voltage level the neuron would have reached in the absence of the interaction and threshold reset...
July 2017: Neural Computation
https://www.readbyqxmd.com/read/28561918/dose-finding-of-lenvatinib-in-subjects-with-advanced-hepatocellular-carcinoma-based-on-population-pharmacokinetic-and-exposure-response-analyses
#19
Toshiyuki Tamai, Seiichi Hayato, Seiichiro Hojo, Takuya Suzuki, Takuji Okusaka, Kenji Ikeda, Hiromitsu Kumada
Hepatocellular carcinoma (HCC) accounts for up to 90% of primary liver cancer occurrences worldwide. Lenvatinib, a multikinase inhibitor, was approved in radioiodine-refractory differentiated thyroid cancer. In this phase 2 study (study 202), we aimed to identify the lenvatinib optimal dose for subjects with advanced HCC Child-Pugh class A. Pooled data from phase 1 studies in healthy adults and in subjects with mixed tumor types, and from study 202 in subjects with HCC, were analyzed using a population pharmacokinetic approach...
May 31, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28556418/phase-i-randomized-study-of-khk4083-an-anti-ox40-monoclonal-antibody-in-patients-with-mild-to-moderate-plaque-psoriasis
#20
K A Papp, M J Gooderham, G Girard, M Raman, V Strout
BACKGROUND: OX40 (CD134) is expressed in lesional but not healthy skin of patients with psoriasis. KHK4083 is a fully human monoclonal antibody against OX40. OBJECTIVE: The primary aim of this first-in-human phase 1 study was to determine the safety and tolerability of ascending single doses of KHK4083 in patients with mild to moderate plaque psoriasis. Secondary aims were to determine the pharmacokinetics and immunogenicity of KHK4083, and an exploratory objective was to assess clinical activity...
May 27, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
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