Displaying publications 1 - 20 of 72 in total

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  1. Liu K, Wang H, Xiao J, Taha Z
    Comput Intell Neurosci, 2015;2015:158478.
    PMID: 25866500 DOI: 10.1155/2015/158478
    The purpose of this research is to analyse the relationship between nonlinear dynamic character and individuals' standing balance by the largest Lyapunov exponent, which is regarded as a metric for assessing standing balance. According to previous study, the largest Lyapunov exponent from centre of pressure time series could not well quantify the human balance ability. In this research, two improvements were made. Firstly, an external stimulus was applied to feet in the form of continuous horizontal sinusoidal motion by a moving platform. Secondly, a multiaccelerometer subsystem was adopted. Twenty healthy volunteers participated in this experiment. A new metric, coordinated largest Lyapunov exponent was proposed, which reflected the relationship of body segments by integrating multidimensional largest Lyapunov exponent values. By using this metric in actual standing performance under sinusoidal stimulus, an obvious relationship between the new metric and the actual balance ability was found in the majority of the subjects. These results show that the sinusoidal stimulus can make human balance characteristics more obvious, which is beneficial to assess balance, and balance is determined by the ability of coordinating all body segments.
  2. Wong FC, Chai TT, Xiao J
    Crit Rev Food Sci Nutr, 2019;59(6):947-952.
    PMID: 29787299 DOI: 10.1080/10408398.2018.1479681
    In our diets, many of the consumed foods are subjected to various forms of heating and thermal processing. Besides enhancing the taste, texture, and aroma of the foods, heating helps to sterilize and facilitate food storage. On the other hand, heating and thermal processing are frequently reported during the preparation of various traditional herbal medicines. In this review, we intend to highlight works by various research groups which reported on changes in phytochemicals and bioactivities, following thermal processing of selected plant-derived foods and herbal medicines. Relevant cases from plant-derived foods (garlic, coffee, cocoa, barley) and traditional herbal medicines (Panax ginseng, Polygonum multiforum, Aconitum carmichaelii Debeaux, Angelica sinensis Radix) will be presented in this review. Additionally, related works using pure phytochemical compounds will also be highlighted. In some of these cases, the amazing formation of new compounds were being reported. Maillard reaction could be concluded as the predominant pathway leading to the formation of new conjugates, along with other possibilities being suggested (degradation, transglycosylation, deglycosylation and dehydration). With collective efforts from all researchers, it is hoped that more details will be revealed and lead to the possible discovery of new, heat-mediated phytochemical conjugates.
  3. Li Y, Liu C, Lin L, Li Y, Xiao J, Loh KH
    Zookeys, 2020;969:137-154.
    PMID: 33013170 DOI: 10.3897/zookeys.969.52069
    The southern lesser pomfret (Pampus minor) is an economically important fish, and its numbers are declining because of overfishing and environmental pollution. In addition, owing to the similarities of its external morphological characteristics to other species in the genus Pampus, it is often mistaken for grey pomfret (P. cinereus) or silver pomfret (P. argenteus) juveniles. In this study, the genetic diversity and structure of 264 P. minor individuals from 11 populations in China and Malaysia coastal waters were evaluated for the first time, to the best of our knowledge, using mitochondrial cytochrome b fragments. The results showed that P. minor had moderate haplotype diversity and low nucleotide diversity. Furthermore, two divergent lineages were detected within the populations, but the phylogenetic structure corresponded imperfectly with geographical location; thus, the populations may have diverged in different glacial refugia during the Pleistocene low sea levels. Analysis of molecular variation (AMOVA) showed that genetic variation originated primarily from individuals within the population. Pairwise FST results showed significant differentiation between the Chinese and Malaysian populations. Except for the Xiamen population, which was classified as a marginal population, the genetic differentiation among the other Chinese populations was not significant. During the Late Pleistocene, P. minor experienced a population expansion event starting from the South China Sea refugium that expanded outward, and derivative populations quickly occupied and adapted to the new habitat. The results of this study will provide genetic information for the scientific conservation and management of P. minor resources.
  4. Zhao J, Xiao J, Lee ML, Ma Y
    Springerplus, 2016;5(1):1633.
    PMID: 27722051
    Slopes are subjected to stress redistributions during underground mining activities, and this may eventually cause deformation or landslide. This paper takes Madaling landslide in Guizhou Province, China as a case study to investigate the failure mechanism and its run-out behaviours by using discrete element method. Previous qualitative analysis indicated that the slope experienced four stages of failure mechanisms: (1) development of tension cracks, (2) development of stepped-like creep cracks, (3) development of potential rupture surfaces, and (4) occurrence of the landslide. PFC2D program was employed to model the pre-failure deformation characteristics in order to verify the failure mechanisms quantitatively. Subsequently, the run-out behaviours of the landslide were analyzed by PFC3D program. The results indicated that the movement could be summarized into four stages: acceleration stage, constant movement stage, rapid movement stage, and deceleration and deposition stage.
  5. Chai TT, Xiao J, Mohana Dass S, Teoh JY, Ee KY, Ng WJ, et al.
    Food Chem, 2021 Mar 15;340:127876.
    PMID: 32871354 DOI: 10.1016/j.foodchem.2020.127876
    Jackfruit is a sweet tropical fruit with very pleasant aroma, and the ripe seeds are edible. In this study, jackfruit seed proteins were isolated and subjected to trypsin digestion. The resultant protein hydrolysate was then subjected to antioxidant assay-guided purification, using centrifugal filtration, C18 reverse-phase and strong cation exchange (SCX) fractionations. The purified SCX fraction was further analyzed by de novo peptide sequencing, and two peptide sequences were identified and synthesized. Peptide JFS-2 (VGPWQK) was detected with antioxidant potential, with EC50 value comparable to that of commercial GSH antioxidant peptide. Additionally, the identified peptides were tested with protein protection potential, in an albumin protein denaturation inhibitory assay. Concurrently, we also investigated the pH, temperature, and gastrointestinal-digestion stability profiles for the identified peptide. With further research efforts, the identified peptides could potentially be developed into preservative agent for protein-rich food systems or as health-promoting diet supplements.
  6. Chai TT, Tan YN, Ee KY, Xiao J, Wong FC
    Crit Rev Food Sci Nutr, 2019;59(sup1):S162-S177.
    PMID: 30663883 DOI: 10.1080/10408398.2018.1561418
    The emergence of bacterial resistance against conventional antibiotics and the growing interest in developing alternative, natural antibacterial agents have prompted the search for plant-derived antibacterial peptides in recent decades. Different classes of endogenous antibacterial peptides have been identified from various plant species. Moreover, protein hydrolysates and hydrolysate-derived peptides with potent antibacterial effects have also been identified from numerous plant sources. Antibacterial peptides are often cationic and amphipathic, consisting of fewer than 100 amino acids. They are able to disrupt bacterial membrane integrity via pore formation and/or compromise bacterial metabolic processes. In this review, we summarize current knowledge on the characteristics and modes of action of antibacterial peptides, as well as salient points concerning the production of antibacterial protein hydrolysates from plant proteins. Examples of plant-derived antibacterial hydrolysates and peptides will be highlighted, with particular attention to less explored seeds, fermented plant foods and agricultural by-products. Promising future research directions with regards to the application of plant-derived antibacterial hydrolysates and peptides in food preservation, farm animal disease management, and nutraceutical/functional food development will be proposed.
  7. Teng H, Chen Y, Lin X, Lv Q, Chai TT, Wong FC, et al.
    Food Chem Toxicol, 2019 Jul;129:138-143.
    PMID: 31034934 DOI: 10.1016/j.fct.2019.04.043
    The aim of this study was to assess the inhibitory effects of Sonchus olearleu extract on the generation of heterocyclic amines in roasted pork patties cooked by pan-frying. All samples were cooked for two different durations (45 min and 105 min) under 200 °C and 230 °C. 2-amino-3-methylimidazo[4,5-f]quinoline (IQ), 2-ami- no-3,8-dimethylimidazo[4,5-f]quinoxaline (MeIQx), 2-amino-3,4,8-trimethylimidazo[4,5-f]quinox-aline (4,8-DiMeIQx), harman, and norharman were detected and quantified. In patties cooked at 230 °C for 105 min, S. olearleu extract (0.5%) significantly inhibited the formation of IQ, harman, and norharman by 39%, 67%, and 63%, respectively. In contrast to IQ, the levels of harman and norharman were significantly reduced by the extracts tested. However, no such effects were observed for MeIQx and 4, 8-DiMeIQx. Notably, the inhibitory effect on heterocyclic amines is significantly correlated with the antioxidant potential and total phenolic content of S. olearleu extract.
  8. Wong FC, Xiao J, Ong MG, Pang MJ, Wong SJ, Teh LK, et al.
    Food Chem, 2019 Jan 15;271:614-622.
    PMID: 30236723 DOI: 10.1016/j.foodchem.2018.07.206
    This study was conducted to identify and characterize antioxidant peptides from the alcalase hydrolysate of the blue-spotted stingray. Purification steps guided by ABTS cation radical (ABTS+) scavenging assay and de novo peptide sequencing produced two peptides, WAFAPA (661.3224 Da) and MYPGLA (650.3098 Da). WAFAPA (EC50 = 12.6 µM) had stronger antioxidant activity than glutathione (EC50 = 13.7 µM) and MYPGLA (EC50 = 19.8 µM). Synergism between WAFAPA and MYPGLA was detected. WAFAPA and MYPGLA surpassed carnosine in their ability to suppress H2O2-induced lipid oxidation. The peptides protected plasmid DNA and proteins from Fenton's reagent-induced oxidative damage. Thermal (25-100 °C) and pH 3-11 treatments did not alter antioxidant activity of the peptides. MYPGLA maintained its antioxidant activity after simulated gastrointestinal digestion, whereas WAFAPA showed a partial loss. The two peptides may have potential applications as functional food ingredients or nutraceuticals, whether used singly or in combination.
  9. Shishir MRI, Suo H, Taip FS, Ahmed M, Xiao J, Wang M, et al.
    PMID: 36919601 DOI: 10.1080/10408398.2023.2188564
    Seed mucilages are potential sources of natural polysaccharides. They are biodegradable, biocompatible, sustainable, renewable, and safe for human consumption. Due to the desirable physicochemical and functional properties (e.g. gelling, thickening, stabilizing, and emulsifying), seed mucilages have attracted extensive attention from researchers for utilization as a promising material for the development of advanced carrier systems. Seed mucilages have been utilized as natural polymers to improve the properties of various carrier systems (e.g. complex coacervates, beads, nanofibers, and gels) and for the delivery of diverse hydrophilic and lipophilic compounds (e.g. vitamins, essential oils, antioxidants, probiotics, and antimicrobial agents) to achieve enhanced stability, bioavailability, bioactivity of the encapsulated molecules, and improved quality attributes of food products. This review highlights the recent progress in seed mucilage-based carrier systems for food and nutraceutical applications. The main contents include (1) sources, extraction methods, and physicochemical and functional characteristics of seed mucilages, (2) application of seed mucilages for the development of advanced carrier systems, (3) major issues associated with carrier fabrication, and (4) mechanisms of carrier development, latest improvements in carrier formulation, carrier efficiency in the delivery of bioactive agents, and application in food and nutraceuticals. Furthermore, major challenges and future perspectives of seed mucilage-based carriers for a commercial application are discussed.
  10. Zheng Y, Wang Q, Zhuang W, Lu X, Miron A, Chai TT, et al.
    Molecules, 2016 Nov 02;21(11).
    PMID: 27827862
    Lotus is an edible and medicinal plant, and the extracts from its different parts exhibit various bioactivities. In the present study, the hot water-soluble polysaccharides from lotus seeds (LSPS) were evaluated for their cancer cell cytotoxicity, immunomodulatory and antitumor activities. LSPS showed significant inhibitory effects on the mouse gastric cancer MFC cells, human liver cancer HuH-7 cells and mouse hepatocarcinoma H22 cells. The animal studies showed that LSPS inhibited tumor growth in H22 tumor-bearing mice with the highest inhibition rate of 45.36%, which is comparable to that induced by cyclophosphamide (30 mg/kg) treatment (50.79%). The concentrations of white blood cells were significantly reduced in cyclophosphamide-treated groups (p < 0.01), while LSPS showed much fewer side effects according to the hematology analysis. LSPS improved the immune response in H22 tumor-bearing mice by enhancing the spleen and thymus indexes, and increasing the levels of serum cytokines including tumor necrosis factor-α and interleukin-2. Moreover, LSPS also showed in vivo antioxidant activity by increasing superoxide dismutase activity, thus reducing the malondialdehyde level in the liver tissue. These results suggested that LSPS can be used as an antitumor and immunomodulatory agent.
  11. Yan S, Su Y, Xiao J, Luo X, Ji Y, Ghazali KHB
    Sensors (Basel), 2023 Oct 24;23(21).
    PMID: 37960380 DOI: 10.3390/s23218680
    Indoor location-based services (LBS) have tremendous practical and social value in intelligent life due to the pervasiveness of smartphones. The magnetic field-based localization method has been an interesting research hotspot because of its temporal stability, ubiquitousness, infrastructure-free nature, and good compatibility with smartphones. However, utilizing discrete magnetic signals may result in ambiguous localization features caused by random noise and similar magnetic signals in complex symmetric and large-scale indoor environments. To address this issue, we propose a deep neural network-based fusion indoor localization system that integrates magnetic and pedestrian dead reckoning (PDR). In this system, we first propose a ResNet-GRU-LSTM neural network model to achieve magnetic localization more accurately. Afterward, we put forward a multifeatured-driven step length estimation. A hierarchy GRU (H-GRU) neural network model is proposed, and a multidimensional dataset using acceleration and a gyroscope is constructed to extract more valid characteristics. Finally, more reliable and accurate pedestrian localization can be achieved under the particle filter framework. Experiments were conducted at two trial sites with two pedestrians and four smartphones. Results demonstrate that the proposed system achieves better accuracy and robustness than other traditional localization algorithms. Moreover, the proposed system exhibits good generality and practicality in real-time localization with low cost and low computational complexity.
  12. Chen Q, Dong L, Li Y, Liu Y, Xia Q, Sang S, et al.
    PMID: 36803106 DOI: 10.1080/10408398.2023.2179969
    Ovalbumin (OVA) is the most abundant protein in egg white, with excellent functional properties (e.g., gelling, foaming, emulsifying properties). Nevertheless, OVA has strong allergenicity, which is usually mediated by specific IgE thus results in gut microbiota dysbiosis and causes atopic dermatitis, asthma, and other inflammation actions. Processing technologies and the interactions with other active ingredients can influence the functional properties and allergic epitopes of OVA. This review focuses on the non-thermal processing technologies effects on the functional properties and allergenicity of OVA. Moreover, the research advance about immunomodulatory mechanisms of OVA-mediated food allergy and the role of gut microbiota in OVA allergy was summarized. Finally, the interactions between OVA and active ingredients (such as polyphenols and polysaccharides) and OVA-based delivery systems construction are summarized. Compared with traditional thermal processing technologies, novel non-thermal processing techniques have less damage to OVA nutritional value, which also improve OVA properties. OVA can interact with various active ingredients by covalent and non-covalent interactions during processing, which can alter the structure or allergic epitopes to affect OVA/active components properties. The interactions can promote OVA-based delivery systems construction, such as emulsions, hydrogels, microencapsulation, nanoparticles to encapsulate bioactive components and monitor freshness for improving foods quality and safety.
  13. Choo SW, Wee WY, Ngeow YF, Mitchell W, Tan JL, Wong GJ, et al.
    Sci Rep, 2014;4:4061.
    PMID: 24515248 DOI: 10.1038/srep04061
    Mycobacterium abscessus (Ma) is an emerging human pathogen that causes both soft tissue infections and systemic disease. We present the first comparative whole-genome study of Ma strains isolated from patients of wide geographical origin. We found a high proportion of accessory strain-specific genes indicating an open, non-conservative pan-genome structure, and clear evidence of rapid phage-mediated evolution. Although we found fewer virulence factors in Ma compared to M. tuberculosis, our data indicated that Ma evolves rapidly and therefore should be monitored closely for the acquisition of more pathogenic traits. This comparative study provides a better understanding of Ma and forms the basis for future functional work on this important pathogen.
  14. Ma ZF, Yusof N, Hamid N, Lawenko RM, Mohammad WMZW, Liong MT, et al.
    Benef Microbes, 2019 Mar 13;10(2):111-120.
    PMID: 30525951 DOI: 10.3920/BM2018.0008
    Individuals in a community who developed irritable bowel syndrome (IBS) after major floods have significant mental health impairment. We aimed to determine if Bifidobacterium infantis M-63 was effective in improving symptoms, psychology and quality of life measures in flood-affected individuals with IBS and if the improvement was mediated by gut microbiota changes. Design was non-randomised, open-label, controlled before-and-after. Of 53 participants, 20 with IBS were given B. infantis M-63 (1×109 cfu/sachet/day) for three months and 33 were controls. IBS symptom severity scale, hospital anxiety and depression scale, SF-36 Questionnaire, hydrogen breath testing for small intestinal bacterial overgrowth and stools for 16S rRNA metagenomic analysis were performed before and after intervention. 11 of 20 who were given probiotics (M-63) and 20 of 33 controls completed study as per-protocol. Mental well-being was improved with M-63 vs controls for full analysis (P=0.03) and per-protocol (P=0.01) populations. Within-group differences were observed for anxiety and bodily pain (both P=0.04) in the M-63 per-protocol population. Lower ratio of Firmicutes/Bacteroidetes was observed with M-63 vs controls (P=0.01) and the lower ratio was correlated with higher post-intervention mental score (P=0.04). B. infantis M-63 is probably effective in improving mental health of victims who developed IBS after floods and this is maybe due to restoration of microbial balance and the gut-brain axis. However, our conclusion must be interpreted within the context of limited sample size. The study was retrospectively registered on 12 October 2017 and the Trial Registration Number (TRN) was NCT03318614.
  15. Wu H, Sang S, Weng P, Pan D, Wu Z, Yang J, et al.
    Compr Rev Food Sci Food Saf, 2023 Nov;22(6):4217-4241.
    PMID: 37583298 DOI: 10.1111/1541-4337.13217
    Starch-based materials have viscoelasticity, viscous film-forming, dough pseudoplasticity, and rheological properties, which possess the structural characteristics (crystal structure, double helix structure, and layered structure) suitable for three-dimensional (3D) food printing inks. 3D food printing technology has significant advantages in customizing personalized and precise nutrition, expanding the range of ingredients, designing unique food appearances, and simplifying the food supply chain. Precision nutrition aims to consider individual nutritional needs and individual differences, which include special food product design and personalized precise nutrition, thus expanding future food resources, then simplifying the food supply chain, and attracting extensive attention in food industry. Different types of starch-based materials with different structures and rheological properties meet different 3D food printing technology requirements. Starch-based materials suitable for 3D food printing technology can accurately deliver and release active substances or drugs. These active substances or drugs have certain regulatory effects on the gut microbiome and diabetes, so as to maintain personalized and accurate nutrition.
  16. El-Seedi HR, Khalifa SAM, Taher EA, Farag MA, Saeed A, Gamal M, et al.
    Pharmacol Res, 2019 03;141:123-175.
    PMID: 30579976 DOI: 10.1016/j.phrs.2018.12.015
    Cardiac glycosides (CGs) are a class of naturally occurring steroid-like compounds, and members of this class have been in clinical use for more than 1500 years. They have been used in folk medicine as arrow poisons, abortifacients, heart tonics, emetics, and diuretics as well as in other applications. The major use of CGs today is based on their ability to inhibit the membrane-bound Na+/K+-ATPase enzyme, and they are regarded as an effective treatment for congestive heart failure (CHF), cardiac arrhythmia and atrial fibrillation. Furthermore, increasing evidence has indicated the potential cytotoxic effects of CGs against various types of cancer. In this review, we highlight some of the structural features of this class of natural products that are crucial for their efficacy, some methods of isolating these compounds from natural resources, and the structural elucidation tools that have been used. We also describe their physicochemical properties and several modern biotechnological approaches for preparing CGs that do not require plant sources.
  17. El-Seedi HR, Yosri N, Khalifa SAM, Guo Z, Musharraf SG, Xiao J, et al.
    J Ethnopharmacol, 2021 Apr 06;269:113626.
    PMID: 33248183 DOI: 10.1016/j.jep.2020.113626
    ETHNOPHARMACOLOGICAL RELEVANCE: Egyptian plants are a rich source of natural molecules, representing considerable biodiversity due to climate variations between the Northern, Southern, Eastern and Western regions of the country. Sinai is considered a precious nature reserves preserving flora, fauna, marine organisms, and historical habitats with ancient origins. Here, traditional medicinal approaches have been used for hundreds of years. Healthy lifestyles, low levels of stress and microbial infections, and a dependence on flora and herbal medicine might in combination explain why the burden of cancer is lower in some regions than in others.

    AIM OF THE STUDY: The primary aim of this review is to document the plants and natural products that are used as foods and medicines in Egypt, in general, and in Sinai, in particular, with a focus on those with demonstrated anticancer activities. The documented traditional uses of these plants are described, together with their chemical and pharmacological activities and the reported outcomes of clinical trials against cancer.

    MATERIALS AND METHODS: A literature search was performed to identify texts describing the medicinal plants that are cultivated and grown in Egypt, including information found in textbooks, published articles, the plant list website (http://www.theplantlist.org/), the medicinal plant names services website (http://mpns.kew.org/mpns-portal/), and web databases (PubMed, Science Direct, and Google Scholar).

    RESULTS AND DISCUSSION: We collected data for most of the plants cultivated or grown in Egypt that have been previously investigated for anticancer effects and reported their identified bioactive elements. Several plant species, belonging to different families and associated with 67 bioactive compounds, were investigated as potential anticancer agents (in vitro studies). The most potent cytotoxic activities were identified for the families Asteraceae, Lamiaceae, Chenopodiaceae, Apocynaceae, Asclepiadaceae, Euphorbiaceae, Gramineae, and Liliaceae. The anticancer activities of some species, such as Punica granatum L., Nerium oleander L., Olea europea L., Matricaria chamomilla L., Cassia acutifolia L., Nigella sativa L., Capsicum frutescens L., Withania somnifera L., and Zingiber officinale Roscoe, have been examined in clinical trials. Among the various Egyptian plant habitats, we found that most of these plants are grown in the North Sinai, New-Delta, and Giza Governorates.

    CONCLUSION: In this review, we highlight the role played by Egyptian flora in current medicinal therapies and the possibility that these plants may be examined in further studies for the development of anticancer drugs. These bioactive plant extracts form the basis for the isolation of phytochemicals with demonstrated anticancer activities. Some active components derived from these plants have been applied to preclinical and clinical settings, including resveratrol, quercetin, isoquercetin, and rutin.

  18. Yusof N, Hamid N, Ma ZF, Lawenko RM, Wan Mohammad WMZ, Collins DA, et al.
    Gut Pathog, 2017;9:75.
    PMID: 29255490 DOI: 10.1186/s13099-017-0224-7
    Background: After an environmental disaster, the affected community is at increased risk for persistent abdominal pain but mechanisms are unclear. Therefore, our study aimed to determine association between abdominal pain and poor water, sanitation and hygiene (WaSH) practices, and if small intestinal bacterial overgrowth (SIBO) and/or gut dysbiosis explain IBS, impaired quality of life (QOL), anxiety and/or depression after a major flood.

    Results: New onset abdominal pain, IBS based on the Rome III criteria, WaSH practices, QOL, anxiety and/or depression, SIBO (hydrogen breath testing) and stools for metagenomic sequencing were assessed in flood victims. Of 211 participants, 37.9% (n = 80) had abdominal pain and 17% (n = 36) with IBS subtyped diarrhea and/or mixed type (n = 27 or 12.8%) being the most common. Poor WaSH practices and impaired quality of life during flood were significantly associated with IBS. Using linear discriminant analysis effect size method, gut dysbiosis was observed in those with anxiety (Bacteroidetes and Proteobacteria, effect size 4.8), abdominal pain (Fusobacteria, Staphylococcus, Megamonas and Plesiomonas, effect size 4.0) and IBS (Plesiomonas and Trabulsiella, effect size 3.0).

    Conclusion: Disturbed gut microbiota because of environmentally-derived organisms may explain persistent abdominal pain and IBS after a major environmental disaster in the presence of poor WaSH practices.

  19. Eich A, Urban V, Jutel M, Vlcek J, Shim JJ, Trofimov VI, et al.
    COPD, 2017 Oct;14(5):476-483.
    PMID: 28753067 DOI: 10.1080/15412555.2017.1335697
    Interleukin (IL)-17A may be an underlying factor in the pathophysiology of chronic obstructive pulmonary disease (COPD). Anti-IL-17 monoclonal antibodies have been used successfully in treating several immune-mediated inflammatory diseases. This phase 2, randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study is the first clinical study evaluating the efficacy and safety of the anti-IL-17A monoclonal antibody CNTO 6785 in patients with symptomatic moderate-to-severe COPD. Patients were treated with CNTO 6785 (n = 93) or placebo (n = 94) intravenously at Weeks 0, 2, and 4 (induction), then Weeks 8 and 12, and followed till Week 24. The primary efficacy endpoint was the change from baseline in pre-bronchodilator percent-predicted forced expiratory volume in 1 second at Week 16. Samples were collected at all visits for pharmacokinetic (PK) evaluation, and standard safety assessments were performed. The mean difference in the primary efficacy endpoint between CNTO 6785 and placebo was not statistically significant (-0.49%; p = 0.599). No other efficacy endpoints demonstrated clinically or statistically significant differences with CNTO 6785 compared with placebo. CNTO 6785 was generally well tolerated; no major safety signals were detected. The most frequently reported treatment-emergent adverse events were infections and infestations; however, no notable differences were observed between CNTO 6785 and placebo in terms of rates of infections. PK results suggested that the steady state of serum CNTO 6785 concentration was reached within 16 weeks. These results suggest that IL-17A is unlikely to be a dominant driver in the pathology of, or a viable therapeutic target for, COPD. ClinicalTrials.gov Identifier: NCT01966549; EudraCT Identifier: 2012-003607-36.
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