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Tocotrienol isoforms:The molecular mechanisms underlying their effects in cancer therapy and their implementation in clinical trials

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Journal of Integrative Medicine 2024年第1期22卷 1-11页

作者： Maria Younes Ghady Loubnane Christopher Sleiman Sandra Rizk Department of Natural Sciences Lebanese American UniversityByblosLebanon

Tocotrienols are found in a variety of natural sources,like rice bran,annatto seeds and palm oil,and have been shown to have several health-promoting properties,particularly against chronic diseases such as cancer.The incidence of cancer is rapidly increasing around the world,not only a result of continued aging and population growth,but also due to the adoption of aspects of the Western lifestyle,such as high-fat diets and low-physical activity.The literature provides strong evidence that tocotrienols are able to inhibit the growth of various cancers,including breast,lung,ovarian,prostate,liver,brain,colon,myeloma and pancreatic cancers.These findings,along with the reported safety profile of tocotrienols in healthy human volunteers,encourage further research into these compounds’potential use in cancer prevention and treatment.The current review provided detailed information about the molecular mechanisms of action of different tocotrienol isoforms in various cancer models and evaluated the potential therapeutic effects of different vitamin E analogues on important cancer hallmarks,such as cellular proliferation,apoptosis,angiogenesis and metastasis.MEDLINE/PubMed and Scopus databases were used to identify recently published articles that investigated the anticancer effects of vitamin E derivatives in various types of cancer in vitro and in vivo along with clinical evidence of adjuvant chemopreventive benefits.Following an overview of pre-clinical studies,we describe several completed and ongoing clinical trials that are paving the way for the successful implementation of tocotrienols in cancer chemotherapy.

关键词： Vitamin E Tocotrienols Cancer Molecular mechanism clinical trials

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Molecular insights into clinical trials for immune checkpoint inhibitors in colorectal cancer:Unravelling challenges and future directions

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World Journal of Gastroenterology 2024年第13期30卷 1815-1835页

作者： Samantha Sharma Naresh Singh Anita Ahmed Turk Isabella Wan Akshay Guttikonda Julia Lily Dong Xinna Zhang Mateusz Opyrchal Department of Medical and Molecular Genetics Indiana University School of MedicineIndianapolisIN 46202United States Division of Hematology/Oncology Department of MedicineIndiana University School of MedicineIndianapolisIN 46202United States Melvin and Bren Simon Comprehensive Cancer Center Indiana University School of MedicineIndianapolisIN 46202United States

Colorectal cancer(CRC)is a complex disease with diverse etiologies and clinical outcomes.Despite considerable progress in development of CRC therapeutics,challenges remain regarding the diagnosis and management of advanced stage metastatic CRC(mCRC).In particular,the five-year survival rate is very low since mCRC is currently rarely curable.Over the past decade,cancer treatment has significantly improved with the introduction of cancer immunotherapies,specifically immune checkpoint inhibitors.Therapies aimed at blocking immune checkpoints such as PD-1,PD-L1,and CTLA-4 target inhibitory pathways of the immune system,and thereby enhance anti-tumor immunity.These therapies thus have shown promising results in many clinical trials alone or in combination.The efficacy and safety of immunotherapy,either alone or in combination with CRC,have been investigated in several clinical trials.clinical trials,including KEYNOTE-164 and CheckMate 142,have led to Food and Drug Administration approval of the PD-1 inhibitors pembrolizumab and nivolumab,respectively,for the treatment of patients with unresectable or metastatic microsatellite instability-high or deficient mismatch repair CRC.Unfortunately,these drugs benefit only a small percentage of patients,with the benefits of immunotherapy remaining elusive for the vast majority of CRC patients.To this end,primary and secondary resistance to immunotherapy remains a significant issue,and further research is necessary to optimize the use of immunotherapy in CRC and identify biomarkers to predict the response.This review provides a comprehensive overview of the clinical trials involving immune checkpoint inhibitors in CRC.The underlying rationale,challenges faced,and potential future steps to improve the prognosis and enhance the likelihood of successful trials in this field are discussed.

关键词： Colorectal cancer Immune checkpoint inhibitors clinical trials Immunotherapy Microsatellite instability Microsatellite stability DNA mismatch repair

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Anti-oxidative stress treatment and current clinical trials

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World Journal of Hepatology 2024年第2期16卷 294-299页

作者： Chun-Ye Zhang Ming Yang Bond Life Sciences Center University of MissouriColumbiaMO 65211United States Department of Surgery University of MissouriColumbiaMO 65212United States

Oxidative stress disturbs the balance between the production of reactive oxygen species(ROS)and the detoxification biological process.It plays an important role in the development and progression of many chronic diseases.Upon exposure to oxidative stress or the inducers of ROS,the cellular nucleus undergoes some biological processes via different signaling pathways,such as stress adaption through the forkhead box O signaling pathway,inflammatory response through the IκB kinase/nuclear factor-κB signaling pathway,hypoxic response via the hypoxia-inducible factor/prolyl hydroxylase domain proteins pathway,DNA repair or apoptosis through the p53 signaling pathway,and antioxidant response through the Kelch-like ECH-associated protein 1/nuclear factor E2-related factor 2 signaling pathway.These processes are involved in many diseases.Therefore,oxidative stress has gained more attraction as a targeting process for disease treatment.Meanwhile,anti-oxidative stress agents have been widely explored in pre-clinical trials.However,only limited clinical trials are performed to evaluate the efficacy of anti-oxidative stress agents or antioxidants in diseases.In this letter,we further discuss the current clinical trials related to anti-oxidative stress treatment in different diseases.More pre-clinical studies and clinical trials are expected to use anti-oxidative stress strategies as disease treatment or dietary supplementation to improve disease treatment outcomes.

关键词： Anti-oxidative stress treatment clinical trials Drugs Dietary invention Reactive oxygen species

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An Overview of Chemical Constituents, Medicinal Properties, clinical trials, and Patents of Twigs of Morus alba(Ramulus Mori)

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World Journal of Traditional Chinese Medicine 2024年第2期10卷 149-158页

作者： Eric Wei Chiang Chan Hung Tuck Chan Siu Kuin Wong Department of Food Science and Nutrition Faculty of Applied Sciences UCSI University Secretariat of International Society for Mangrove Ecosystems Faculty of Agriculture University of the Ryukyus School of Foundation Studies Xiamen University Malaysia

The rich chemical constituents and diverse pharmacological properties of Ramulus Mori(RM) or the twig of Morus alba with evidence supported by clinical trials and patents are reviewed. Known as Sangzhi in Chinese, RM is widely used in traditional Chinese medicine to treat gout, arthritis, and rheumatism. Chemical constituents include flavonoids, benzofurans, alkaloids, stilbenes, chalcones, phenolic acids, and coumarins. Bioactivities of RM include antidiabetic, anti-obesity, anti-inflammatory, antityrosinase, neuroprotective, antioxidant, hepatoprotective, cytoprotective, renoprotective, antihyperuricemic, analgesic, antifungal, DNA protective, anticancer, gastroprotective, cardioprotective, anti-hair aging, anti-arthritic, and antiplatelet aggregation properties. The most active compounds from RM are mulberrin, oxyresveratrol, and mulberroside A. All four clinical trials on RM are focused on the treatment of diabetes. The patents entail using RM extracts as cosmetics for skin whitening and as agents for hypoglycemia. Topics for further research on RM are suggested.

关键词： clinical trials mulberrin mulberroside A oxyresveratrol patents Sangzhi

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BET in hematologic tumors:Immunity,pathogenesis,clinical trials and drug combinations

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Genes & Diseases 2023年第6期10卷 2306-2319页

作者： Tao Ma Yan Chen Zhi-Gang Yi Yan-Hong Li Jun Bai Li-Juan Li Lian-Sheng Zhang Department of Hematology The Affiliated Hospital of Southwest Medical UniversityLuzhouSichuan 646000China Department of Hematology Lanzhou University Second HospitalLanzhouGansu 730000China

The bromodomain and extra-terminal(BET)proteins act as“readers”for lysine acetylation and facilitate the recruitment of transcriptional elongation complexes.BET protein is associated with transcriptional elongation of genes such as c-MYC and BCL-2,and is involved in the regulation of cell cycle and apoptosis.Meanwhile,BET inhibitors(BETi)have regulatory effects on immune checkpoints,immune cells,and cytokine expression.The role of BET proteins and BETi in a variety of tumors has been studied.This paper reviews the recent research progress of BET and BETi in hematologic tumors(mainly leukemia,lymphoma and multiple myeloma)from cellular level studies,animal studies,clinical trials,drug combination,etc.BETi has a promising future in hematologic tumors,and future research directions may focus on the combination with other drugs to improve the efficacy.

关键词： BET BRD4 clinical trials Hematologic tumors Immunity MYC

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Targeting RAS-RAF-MEK-ERK signaling pathway in human cancer:Current status in clinical trials

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Genes & Diseases 2023年第1期10卷 76-88页

作者： Yanlin Song Zhenfei Bi Yu Liu Furong Qin Yuquan Wei Xiawei Wei Laboratory of Aging Research and Cancer Drug Target State Key Laboratory of Biotherapy and Cancer CenterNational Clinical Research Center for GeriatricsWest China HospitalSichuan UniversityChengduSichuan610041China

Molecular target inhibitors have been regularly approved by Food and Drug Administration(FDA)for tumor treatment,and most of them intervene in tumor cell proliferation and metabolism.The RAS-RAF-MEK-ERK pathway is a conserved signaling pathway that plays vital roles in cell proliferation,survival,and differentiation.The aberrant activation of the RAS-RAF-MEK-ERK signaling pathway induces tumors.About 33%of tumors harbor RAS mutations,while 8%of tumors are driven by RAF mutations.Great efforts have been dedicated to targeting the signaling pathway for cancer treatment in the past decades.In this review,we summarized the development of inhibitors targeting the RAS-RAF-MEK-ERK pathway with an emphasis on those used in clinical treatment.Moreover,we discussed the potential combinations of inhibitors that target the RAS-RAF-MEK-ERK signaling pathway and other signaling pathways.The inhibitors targeting the RAS-RAF-MEK-ERK pathway have essentially modified the therapeutic strategy against various cancers and deserve more attention in the current cancerresearchandtreatment.

关键词： clinical trials Molecular target therapy RAS-RAF-MEK-ERK signaling pathway

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clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations

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Translational Neurodegeneration 2022年第1期11卷 514-531页

作者： Federico Rodriguez-Porcel Kathryn A.Wyman-Chick Carla Abdelnour Ruiz Jon B.Toledo Daniel Ferreira Prabitha Urwyler Rimona S.Weil Joseph Kane Andrea Pilotto Arvid Rongve Bradley Boeve John-Paul Taylor Ian McKeith Dag Aarsland Simon J.G.Lewis the Lewy Body Dementias clinical trials Workgroup from the Lewy Body Dementias Professional Interest Area-Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment(ISTAART) Department of Neurology Medical University of South Carolina208b Rutledge Av.CharlestonSC 29403USA Department of Neurology Center for Memory and AgingHealthPartnersSaint PaulMNUSA Autonomous University of Barcelona BarcelonaSpain Fixel Institute for Neurological Diseases University of FloridaGainesvilleFLUSA Division of clinical Geriatrics Department of NeurobiologyCare Sciencesand SocietyCenter for Alzheimer’s ResearchKarolinska InstitutetStockholmSweden Department of Radiology Mayo ClinicRochesterMNUSA ARTORG Center for Biomedical Engineering Research University of BernBernSwitzerland Dementia Research Centre University College LondonLondonUK Centre for Public Health Queen’s UniversityBelfastUK Neurology Unit Department of Clinical and Experimental SciencesUniversity of BresciaBresciaItaly Department of Research and Innovation Helse FonnaHaugesund HospitalHaugesundNorway Institute of clinical Medicine(K1) The University of Ber-genBergenNorway Department of Neurology Center for Sleep MedicineMayo ClinicRochesterMNUSA Translational and clinical Research Institute Newcastle UniversityNewcastle upon TyneUK Department of Old Age Psychiatry Institute of Psychiatry Psychology and Neuroscience King’s College LondonLondonUK ForeFront Parkinson’s Disease Research Clinic Brain and Mind CentreSchool of Medical SciencesUniversity of Sydney100 Mallett StreetCamperdownNSW 2050Australia. 不详

The selection of appropriate outcome measures is fundamental to the design of any successful clinical trial. Although dementia with Lewy bodies (DLB) is one of the most common neurodegenerative conditions, assessment of therapeutic benefit in clinical trials often relies on tools developed for other conditions, such as Alzheimer’s or Parkinson’s disease. These may not be sufficiently valid or sensitive to treatment changes in DLB, decreasing their utility. In this review, we discuss the limitations and strengths of selected available tools used to measure DLB-associated outcomes in clinical trials and highlight the potential roles for more specific objective measures. We emphasize that the existing outcome measures require validation in the DLB population and that DLB-specific outcomes need to be developed. Finally, we highlight how the selection of outcome measures may vary between symptomatic and disease-modifying therapy trials.

关键词： Dementia with Lewy bodies clinical trials Outcomes Measurement properties

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Global trends in diabetic eye disease research from 2012 to 2021

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Neural Regeneration Research 2024年第10期19卷 2310-2320页

作者： Yuan Yuan Shangli Ji Yali Song Zhaodi Che Lu Xiao Shibo Tang Jia Xiao Aier School of Ophthalmology Central South UniversityChangshaHunan ProvinceChina Changsha Aier Eye Hospital ChangshaHunan ProvinceChina Aier Eye Institute ChangshaHunan ProvinceChina Department of Metabolic and Bariatric Surgery The First Affiliated Hospital of Jinan UniversityGuangzhouGuangdong ProvinceChina

Diabetic eye disease refers to a group of eye complications that occur in diabetic patients and include diabetic retinopathy, diabetic macular edema, diabetic cataracts, and diabetic glaucoma. However, the global epidemiology of these conditions has not been well characterized. In this study, we collected information on diabetic eye disease-related research grants from seven representative countries––the United States, China, Japan, the United Kingdom, Spain, Germany, and France––by searching for all global diabetic eye disease journal articles in the Web of Science and Pub Med databases, all global registered clinical trials in the clinical trials database, and new drugs approved by the United States, China, Japan, and EU agencies from 2012 to 2021. During this time period, diabetic retinopathy accounted for the vast majority(89.53%) of the 2288 government research grants that were funded to investigate diabetic eye disease, followed by diabetic macular edema(9.27%). The United States granted the most research funding for diabetic eye disease out of the seven countries assessed. The research objectives of grants focusing on diabetic retinopathy and diabetic macular edema differed by country. Additionally, the United States was dominant in terms of research output, publishing 17.53% of global papers about diabetic eye disease and receiving 22.58% of total citations. The United States and the United Kingdom led international collaborations in research into diabetic eye disease. Of the 415 clinical trials that we identified, diabetic macular edema was the major disease that was targeted for drug development(58.19%). Approximately half of the trials(49.13%) pertained to angiogenesis. However, few drugs were approved for ophthalmic(40 out of 1830;2.19%) and diabetic eye disease(3 out of 1830;0.02%) applications. Our findings show that basic and translational research related to diabetic eye disease in the past decade has not been highly active, and has yielded few new treatment methods and newly approved drugs.

关键词： clinical trials diabetic cataracts diabetic eye disease diabetic glaucoma diabetic macular edema diabetic retinopathy drug development global research publication research grant

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clinical applications of the CRISPR/Cas9 genome-editing system: Delivery options and challenges in precision medicine

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Genes & Diseases 2024年第1期11卷 268-282页

作者： Mohadeseh Khoshandam Hossein Soltaninejad Marziyeh Mousazadeh Amir Ali Hamidieh Saman Hosseinkhani Department of Reproductive Biology Academic Center for EducationCultureand Research(ACECR)Qom BranchQom ***Iran National Institute of Genetic Engineering and Biotechnology(NIGEB) Tehran 14155-6463Iran Faculty of Interdisciplinary Science and Technology Tarbiat Modares UniversityTehran 14117-13116Iran Pediatric Cell and Gene Therapy Research Center GeneCell&Tissue Research InstituteTehran UniversityofMedical SciencesTehran14155-6559Iran Department of Nanobiotechnology Faculty of Biological SciencesTarbiat Modares UniversityTehran 14117-13116Iran Department of Biochemistry Faculty of Biological SciencesTarbiat Modares UniversityTehran 14117-13116Iran

CRISPR/Cas9 is an effective gene editing tool with broad applications for the pre-vention or treatment of numerous diseases.It depends on CRiSPR(clustered regularly inter-spaced short palindromic repeats)as a bacterial immune system and plays as a gene editing tool.Due to the higher specificity and efficiency of CRISPR/Cas9 compared to other editing ap-proaches,it has been broadly investigated to treat numerous hereditary and acquired ill-nesses,including cancers,hemolytic diseases,immunodeficiency disorders,cardiovascular diseases,visual maladies,neurodegenerative conditions,and a few X-linked disorders.CRISPR/Cas9 system has been used to treat cancers through a variety of approaches,with sta-ble gene editing techniques.Here,the applications and clinical trials of CRisPR/Cas9 in various illnesses are described.Due to its high precision and efficiency,CRISPR/Cas9 strategies may treat gene-related illnesses by deleting,inserting,modifying,or blocking the expression of specific genes.The most challenging barrier to the in vivo use of CRISPR/Cas9 like off-target effects will be discussed.The use of transfection vehicles for CRISPR/Cas9,including viral vectors(such as an Adeno-associated virus(AAV),and the development of non-viral vectors is also considered.

关键词： clinical trials CRISPR/Cas9 Gene therapy Non-viral vectors Viral vectors

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clinical trials in otology:Examining trends and framework for prioritization

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Journal of Otology 2021年第2期16卷 95-98页

作者： Jake Altshuler Rohan Viswanathan Divya B.Dasani Katherine Webb Tam Ramsey Varun Patel Randall Ruffner Jason Mouzakes David Foyt Division of Otolaryngology-Head and Neck Surgery Albany Medical Center50 New Scotland AvenueAlbanyNY12208United States

Objective:To characterize otologic clinical trials and examine otologic clinical trial trends from 2008 to 2018 using the clinicaltrials.gov database.Methods:Data was collected from clinicaltrials.gov and included all clinical trials that focused on otology from 2008 to 2018.Outcome measures include status of trials,funding sources,details regarding otologic conditions studied,and trends in clinical trials.Results:There were 992 otology clinical trials from 2008 to 2018.457(46.1%)were completed and 94(9.5%)were discontinued.Industry remained the highest(76.5%)contributor to otology clinical trials.The otologic conditions studied,from most common to least common,include hearing loss(40.6%),vestibulopathy(18.8%),tinnitus(18.8%),and otitis media(15.1%).The number of otology clinical trials increased by an average of 12.0 trials per year from 2008 to 2018(pclinical trials focusing on hearing loss and vestibulopathy significantly increased over the studied period(pclinical trials on each of these four conditions focused on treatment options.Conclusion:Our study describes trends in otology clinical trials registered on clinicaltrials.gov from 2008 through 2018.The total number of clinical trials over this time period increased significantly,driven by trials investigating hearing loss and vestibulopathy.Furthermore,most clinical trials were industrysponsored and focused on treatment modalities.Our study provides an outline of otology clinical trials registered in a US web-based database,which may be of use for the development of future clinical trials.

关键词： Otology clinical trials Otology trend

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