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Updated overall survival and circulating tumor DNA analysis of ensartinib for crizotinib-refractory ALK-positive NSCLC from a phase II study

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Cancer Communications 2024年第4期44卷 455-468页

作者： Jing Zheng Tao Wang Yunpeng Yang Jie Huang Jifeng Feng Wu Zhuang Jianhua Chen Jun Zhao Wei Zhong Yanqiu Zhao Yiping Zhang Yong Song Yi Hu Zhuang Yu Youling Gong Yuan Chen Feng Ye Shucai Zhang Lejie Cao Yun Fan Gang Wu Yubiao Guo Chengzhi Zhou Kewei Ma Jian Fang Weineng Feng Yunpeng Liu Zhendong Zheng Gaofeng Li Huijie Wang Shundong Cang Ning Wu Wei Song Xiaoqing Liu Shijun Zhao Lieming Ding Giovanni Selvaggi Yang Wang Shanshan Xiao Qian Wang Zhilin Shen Jianya Zhou Jianying Zhou Li Zhang Department of Respiratory Disease Thoracic Disease CenterThe First Affiliated HospitalCollege of MedicineZhejiang UniversityZhejiang Provincial Clinical Research Center for Respiratory DiseaseHangzhouZhejiangP.R.China Hangzhou Repugene Technology Co. LtdHangzhouZhejiangP.R.China Department of Medical Oncology Sun Yat-sen University Cancer Cen-terState Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangzhouGuangdongP.R.China Department of Medical Oncology Jiangsu Cancer HospitalJiangsu Institute of Cancer ResearchThe Affiliated Cancer Hospital of Nanjing Medical UniversityNanjingJiangsuP.R.China Department of Thoracic Oncology Fujian Provincial Cancer HospitalFujian Medical University Cancer HospitalFuzhouFujianP.R.China Department of Medical Oncology-Chest Hunan Cancer HospitalChangshaHunanP.R.China Department of Thoracic Oncology Beijing Cancer HospitalBeijingP.R.China Department of Pulmonary Medicine Peking Union Medical College HospitalChinese Academy of Medical SciencesPeking Union Medical CollegeBeijingP.R.China Respiratory Department of Internal Medicine Henan Provincial Can-cer HospitalAffiliated Cancer Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China Thoracic Medical Oncology Zhejiang Cancer HospitalHangzhouZhejiangP.R.China division of Respiratory Medicine Jinling HospitalNanjing University School of MedicineNanjingJiangsuP.R.China Department of Oncology Chinese People’s Liberation Army(PLA)General HospitalBeijingP.R.China Department of Oncology The Affiliated Hospital of Qingdao UniversityQingdaoShandongP.R.China Department of Thoracic Oncology Cancer CenterWest China HospitalSichuan UniversityChengduSichuanP.R.China Department of Oncology Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiP.R.China Department of Medical Oncology Cancer HospitalThe First Affiliated Hospital of Xiamen UniversitySchool of MedicineXiamen UniversityTeaching Hospital of

Background:The initial phase II stuty(NCT03215693)demonstrated that ensartinib has shown clinical activity in patients with advanced crizotinib-refractory,anaplastic lymphoma kinase(ALK)-positive non-small cell lung cancer(NSCLC).Herein,we reported the updated data on overall survival(OS)and molecular profiling from the initial phase Ⅱ ***:In this study,180 patients received 225 mg of ensartinib orally once daily until disease progression,death or *** was estimated by Kaplan‒Meier methods with two-sided 95%confidence intervals(CIs).Next-generation sequencing was employed to explore prognostic biomarkers based on plasma samples collected at baseline and after initiating *** tumor DNA(ctDNA)was detected to dynamically monitor the genomic alterna-tions during treatment and indicate the existence of molecular residual disease,facilitating improvement of clinical ***:At the data cut-off date(August 31,2022),with a median follow-up time of 53.2 months,97 of 180(53.9%)patients had *** median OS was 42.8 months(95%CI:29.3-53.2 months).A total of 333 plasma samples from 168 patients were included for ctDNA *** inferior OS correlated sig-nificantly with baseline ALK or tumor protein 53(TP53)*** addition,patients with concurrent TP53 mutations had shorter OS than those without con-current TP53 *** ctDNA levels evaluated by variant allele frequency(VAF)and haploid genome equivalents per milliliter of plasma(hGE/mL)at baseline were associated with poor ***,patients with ctDNA clear-ance at 6 weeks and slow ascent growth had dramatically longer OS than those with ctDNA residual and fast ascent growth,***,patients who had a lower tumor burden,as evaluated by the diameter of target lesions,had a longer *** Cox regression analysis further uncovered the independent prognostic values of bone metastases,higher hGE,and elevated ALK mutation abundance at 6 we

关键词： anaplastic lymphoma kinase ctDNA ensartinib non-small cell lung cancer overall survival

A human translational model based on neuroplasticity for pharmacological agents potentially effective in Treatment-Resistant Depression: focus on dopaminergic system

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Neural Regeneration research 2020年第6期15卷 1027-1029页

作者： Ginetta Collo Emilio Merlo Pich Department of Molecular and Translational Medicine Section of PharmacologyUniversity of BresciaBresciaItaly Department of Biomedicine University of BaselBaselSwitzerland(Collo G)Neuroscience Therapeutic Area UnitTakeda Pharmaceuticals InternationalZurichSwitzerland division of Brain Science Imperial CollegeLondonUK(Merlo Pich E

Major depressive disorder(MDD)is a common psychiatric condition characterized by two main symptoms,low mood and *** 15–30%of people suffering from MDD do not respond to standard-of-care antidepressants,e.g.,the serotonin re-uptake inhibitors(SSRI),and are considered affected by Treatment-Resistant Depression(TRD).The neurobiology of this condition is presently *** attempts of developing novel treatments for TRD have been driven by four major breakthroughs:(1)Increasing dopaminergic neurotransmission improves TRD symptoms;(2)Anhedonia occurs when central dopaminergic neurotransmission is low;(3)Enhanced neuroplasticity is critical for the action of antidepressants;(4)Ketamine shows antidepressant properties in TRD patients and triggers neuroplasticity in preclinical animal *** breakthroughs are at the basis of a putative human translational cellular model for antidepressant agents that we are proposing in this *** rationale is briefly described here.

关键词： breakthrough plasticity translational

Poly(ADP-ribose) polymerase inhibition reveals a potential mechanism to promote neuroprotection and treat neuropathic pain

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Neural Regeneration research 2016年第10期11卷 1545-1548页

作者： Prashanth Komirishetty Aparna Areti Ranadeep Gogoi Ramakrishna Sistla Ashutosh Kumar Department of Pharmacology and Toxicology National Institute of Pharmaceutical Education and Research (NIPER)-Hyderabad BalanagarIndia Department of Biotechnology National Institute of Pharmaceutical Education and Research (NIPER)-Guwahati Assam India Pharmacology division Indian Institute of Chemical Technology (IICT) Hyderabad India

Neuropathic pain is triggered by the lesions to peripheral nerves which alter their structure and function. Neuroprotective approaches that jimit the pathological changes and improve the behavioral outcome have been well explained in different experimental models of neuropathy but translation of such strategies to clinics has been disappointing. Experimental evidences revealed the role of free radicals, especially per- oxynitrite after the nerve injury. They provoke oxidative DNA damage and consequent over-activation of the poly（ADP-ribose） polymerase （PARP） upregulates pro-inflammatory pathways, causing bioenergetic crisis and neuronal death. Along with these changes, it causes mitochondrial dysfunction leading to neu- ronal apoptosis. In related preclinical studies agents that neutralize the free radicals and pharmacological inhibitors of PARP have shown benefits in treating experimental neuropathy. This article reviews the in- volvement of PARP over-activation in trauma induced neuropathy and therapeutic significance of PARP inhibitors in the experimental neuropathy and neuropathic pain.

关键词： neuropathic pain poly(ADP-ribose) polymerase neuroinflammation oxidative stress bioenergeticcrisis

Control strategy and methods for continuous direct compression processes

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Asian Journal of Pharmaceutical Sciences 2021年第2期16卷 253-262页

作者： Yasuhiro Suzuki Hirokazu Sugiyama Manabu Kano Ryutaro Shimono Gosuke Shimada Ryoichi Furukawa Eichi Mano Keiichi Motoyama Tatsuo Koide Yasuhiro Matsui Kazuki Kurasaki Issei Takayama Shunin Hikage Noriko Katori Masahiko Kikuchi Hiroshi Sakai Yoshihiro Matsuda Formulation Technology research Laboratories Daiichi Sankyo Co.Ltd.Kanagawa 254-0014Japan Department of Chemical System Engineering The University of TokyoTokyo 113-8656Japan Department of Systems Science Kyoto UniversityKyoto 606-8501Japan CMC Sciences Department Regulatory Affairs DivisionR&D DivisionJanssen Pharmaceutical K.K.Tokyo 101-0065Japan EuroTechno Ltd. Kanagawa 223-0057Japan Pharmaceutical research Department Mitsubishi Tanabe Pharma CorporationOsaka 532-8505Japan Chemical Products CMC Regulatory Affairs Area Japan DevelopmentMSD K.K.Tokyo 102-8667Japan Graduate School of Pharmaceutical Sciences Kumamoto UniversityKumamoto 862-0973Japan division of Drugs National Institute of Health SciencesKawasaki 210-9501Japan Technology research&Development Sumitomo Dainippon Pharma Co.Ltd.Osaka 564-0053Japan Formulation Development Department Chugai pharmaceutical Co.Ltd.Tokyo 115-8543Japan Office of New Drug IV Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan Office of Generic Drugs Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan KOKANDO Co. Ltd.Toyama 930-8580Japan pharmaceuticals and Medical Devices Agency Shin-Kasumigaseki Bldg.Tokyo 100-0013Japan

We presented a control strategy for tablet manufacturing processes based on continuous direct *** work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in *** different items in the process,the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch *** control and management of the Loss in Weight(LIW)feeder were deemed the most important,and the Residence Time Distribution(RTD)model were regarded effective for setting the control range and for controlling of the LIW *** on these ideas,the concept of process control using RTD was summarized.

关键词： Continuous manufacturing Solid drug products Process control Residence time distribution Loss in weight feeder Regulatory science

IL-6 prevents Th2 cell polarization by promoting SOCS3-dependent suppression of IL-2 signaling

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Cellular & Molecular Immunology 2023年第6期20卷 651-665页

作者： Holly Bachus Erin McLaughlin Crystal Lewis Amber M.Papillion Etty N.Benveniste Dave Durell Hill Alexander F.Rosenberg AndréBallesteros-Tato Beatriz León Department of Medicine Division of Clinical Immunology and RheumatologyUniversity of Alabama at BirminghamBirminghamALUSA Department of Microbiology University of Alabama at BirminghamBirminghamALUSA Department of Cell Developmental and Integrative BiologyUniversity of Alabama at BirminghamBirminghamALUSA informatics Institute University of Alabama at BirminghamBirminghamALUSA Alexion pharmaceuticals Inc.New HavenCTUSA

Defective interleukin-6 (IL-6) signaling has been associated with Th2 bias and elevated IgE levels. However, the underlying mechanism by which IL-6 prevents the development of Th2-driven diseases remains unknown. Using a model of house dust mite (HDM)-induced Th2 cell differentiation and allergic airway inflammation, we showed that IL-6 signaling in allergen-specific T cells was required to prevent Th2 cell differentiation and the subsequent IgE response and allergic inflammation. Th2 cell lineage commitment required strong sustained IL-2 signaling. We found that IL-6 turned off IL-2 signaling during early T-cell activation and thus inhibited Th2 priming. Mechanistically, IL-6-driven inhibition of IL-2 signaling in responding T cells was mediated by upregulation of Suppressor Of Cytokine Signaling 3 (SOCS3). This mechanism could be mimicked by pharmacological Janus Kinase-1 (JAK1) inhibition. Collectively, our results identify an unrecognized mechanism that prevents the development of unwanted Th2 cell responses and associated diseases and outline potential preventive interventions.

关键词： Th2 cell polarization IL-6 IL-2 SOCS3 JAK1 inhibitor

The Epidemiological Characteristics of Beijing Lineage Mycobacterium tuberculosis from a National Referral Center in China

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Biomedical and Environmental Sciences 2015年第7期28卷 539-543页

作者： LI Xiao Ying LI Ying ZHANG Yao KANG Wan Li ZHAO Li Ping DING Peng Ju DAI Wen Tao HUANG Hai Rong HUANG Yan Feng LI Wei Min Tianjin Children’s Hospital Zhejiang Provincial Key Laboratory for Technology & Application of Model Organisms School of Laboratory Medicine and Life Science Wenzhou Medical University Clinical Epidemiology Unit Peking Union Medical College Department of Epidemiology Beijing Tuberculosis and Thoracic Tumor Research InstituteBeijing Chest HospitalCapital Medical University National Tuberculosis Clinical Lab of China Beijing Tuberculosis and Thoracic Tumor Research Institute Beijing Chest HospitalCapital Medical University Beijing Key Laboratory for Drug-Resistant Tuberculosis research Beijing Tuberculosis and Thoracic Tumor Research InstituteBeijing Chest HospitalCapital Medical University Key Laboratory of Protein and Peptide pharmaceuticals Institute of BiophysicsChinese Academy of Sciences division of Infectious Disease and Gastroenterology Children’s HospitalChongqing Medical University

Our study was to investigate the epidemiological characteristics of *** from a national tuberculosis referral center in China. All strains isolated from TB patients, were genotyped by the RD105 deletion, 8 and 51 SNP loci and VNTR. The high differentiation SNPs of modern Beijing strains were analyzed for protein function and structure. 413 M. tuberculosis were included. Of 379 Beijing lineage M. tuberculosis, ＇modern＇ and ＇ancient＇ strains respectively represented 85.5% （324/379） and 14.5% （55/379）. Rv2494 （V48A） and Rv0245 （Sl03F） were confirmed as high differentiation SNPs associated with modern strains. In a word, Modern Beijing lineage *** was dominant and the structural models suggested that modern sub-lineage may more easily survive in ＇extreme＇ host condition.

关键词： The Epidemiological Characteristics of Beijing Lineage Mycobacterium tuberculosis from a National Referral Center in China SNPs VNTR Figure MST

Exposure of juvenile Chinook salmon to effluent from a large urban wastewater treatment *** *** profiling

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Aquaculture and Fisheries 2024年第3期9卷 367-377页

作者： James P.Meador Suzanne C.Ball C.Andrew James Jenifer K.McIntyre Dept.of Environmental and Occupational Health Sciences School of Public Health4225 Roosevelt Way NESuite 100SeattleWA98105-6099USA Washington State University School of the EnvironmentPuyallup Research and Extension Center2606 W Pioneer AvePuyallupWA98371USA University of Washington Tacoma Center for Urban Waters326 East D StreetTacomaWA98421-1801USA

Targeted metabolomic analysis was conducted on juvenile Chinook salmon exposed for 10 days to wastewater effluent(WWE)from a large urban treatment *** included five dilutions of WWE(20%,5.3%,1.4%,0.4%,and 0.1%)and a control with 7 replicates per *** was extracted from fish and analyzed via liquid chromatography–mass spectrometry(LC-MS)for 361 endogenous metabolites,of which 185 were ***-versus-treatment comparisons identified several metabolites that were associated with altered biochemical pathways observed for all treatments,including several that are important for energy generation and *** altered pathways are crucial for fish health and may be an early indicator of potential adverse effects on growth,reproduction,behavior,and immune *** ocean-type Chinook salmon spend several days to weeks in the nearshore estuary where they may encounter high concentrations of WWE *** are exposed to a wide range of potent pharmaceuticals,personal care products,and industrial compounds from WWE that have the potential to affect physiological homeostasis and disrupt their normal life cycle.

关键词： Wastewater effluent Metabolomics Physiology Chinook salmon pharmaceuticals Metabolic pathways Estuary

Anti-MMP-2 and MMP-9 activity of Salsola komarovii Iljin extract and its solvent fractions

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Asian Pacific Journal of Tropical Biomedicine 2020年第10期10卷 460-469页

作者： Jung-Ha Kil Fatih Karadeniz Ga Hyun Yu Hojun Kim Junse Kim Jung Hwan Oh Jung Im Lee Chang-SukKong Youngwan Seo Marine Biotechnology Center for pharmaceuticals and Foods Silla UniversityBaegyang-daero 700 beon-gil 140Sasang-guBusan 46958Korea Department of Food and Nutrition College of Medical and Life SciencesSilla UniversityBaegyang-daero 700 beon-gil 140Sasang-guBusan 46958Korea division of Marine Bioscience Korea Maritime and Ocean UniversityBusan 49112Korea

Objective: To investigate matrix metalloproteinases(MMP)-2 and MMP-9 inhibitory effect of Salsola komarovii Iljin, an edible halophyte with health beneficial ***: Salsola komarovii crude extracts(SKI), and solvent(n-hexane, 85% aq. MeOH, n-BuOH, and H2O) fractionated extracts of SKI were prepared. Gelatin zymography was carried out to observe MMP enzymatic activity. The release of the MMP enzymes was measured by enzyme-linked immunosorbent assay. Expression of MMPs in m RNA and protein level were investigated by polymerase chain reaction analysis and immunoblotting, ***: SKI and SKI fractions inhibited active MMP-2 and MMP-9 amount in the treated cell culture medium. Also, SKI suppressed the release of MMP-2 and MMP-9 from stimulated HT1080 human fibrosarcoma cells. Furthermore, SKI suppressed the m RNA and protein expression of MMP-2 and MMP-9. SKI fractions showed parallel effects except for H2O fraction which did not yield any significant MMP inhibitory effect. Among fractions, 85% aq. Me OH was the most active fraction to inhibit both the enzymatic effect and expression of MMP-2 and ***: SKI may contain potential MMP release inhibitory compounds. Salsola komarovii is a promising source of compounds against MMP and could be utilized in the development of antitumor agents.

关键词： release utilized effect

Removal of nanoparticles by coagulation

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Journal of Environmental Sciences 2015年第12期27卷 168-171页

作者： Aleksandra Popowich Qi Zhang X.Chris Le division of Analytical and Environmental Toxicology Department of Laboratory Medicine and PathologyUniversity of Alberta

Nanoparticles（NPs）from anthropogenic sources have applications in several commercial products,including cosmetics,pharmaceuticals,and *** is evidence that during their usage and disposal,engineered nanoparticles can and will be released into wastewater（Gottschalk et al.,2013;Pasricha et al.,2012;Westerhoff et al.,2013;Zheng et al.,2015）.If water and wastewater treatment plants are inefficient or incapable of removing NPs from water,NPs will be released with the treated effluent,entering drinking water sources and natural aquatic environments,increasing exposure for plants,microorganisms,

关键词： Aluminum chloride (AlCl3) Carbon nanotubes (CNTs) Titanium oxide (TiO2) Nanoparticles Humic acid Ionic strength Water treatment