2025
Uric Acid Stroke Cerebroprotection Transcended Sex, Age, and Comorbidities in a Multicenter Preclinical Trial
Patel R, Kumskova M, Kodali H, Budnik I, Kuznetsov V, Jain A, Jha A, Thedens D, Dhanesha N, Sutariya B, Nagarkatti K, Lamb J, Kamat P, Shi Y, Avery B, Imai T, Jin X, Chauhan A, Boisserand L, Khan M, Dhandapani K, Sanganahalli B, Sansing L, Hess D, Koehler R, McCullough L, Aronowski J, Ayata C, Diniz M, Lyden P, Planas A, Chamorro A, Chauhan A, Leira E, Investigators O. Uric Acid Stroke Cerebroprotection Transcended Sex, Age, and Comorbidities in a Multicenter Preclinical Trial. Stroke 2025, 56: 965-973. PMID: 40091742, PMCID: PMC11932773, DOI: 10.1161/strokeaha.124.048748.Peer-Reviewed Original ResearchConceptsUA-treated animalsPrimary functional outcomeFunctional outcomesMiddle cerebral artery filament occlusionModified intention-to-treat populationIntention-to-treat populationUric acidHuman clinical trialsImprove functional outcomesStudy drugIntravenous salineEffects of UARelevant to patientsClinical trialsPrimary outcomeSaline controlsSecondary outcomesPreclinical trialsDay 2Survival rateDay 7Filament occlusionGroups of animalsComorbiditiesDiverse comorbidities
2024
Vaccines as Immunotherapies for Substance Use Disorders
Kosten T. Vaccines as Immunotherapies for Substance Use Disorders. American Journal Of Psychiatry 2024, 181: 362-371. PMID: 38706331, DOI: 10.1176/appi.ajp.20230828.Peer-Reviewed Original ResearchConceptsSubstance use disordersHuman clinical trials of vaccinesPreclinical vaccine studiesClinical trials of vaccinesVaccine clinical trialsHuman clinical trialsTrials of vaccinesVaccine immunotherapyIllicit fentanyl useOpioid pharmacotherapyEffective therapySubstance use disorder treatmentFentanyl useClinical trialsVaccine studiesAnimal modelsAnimal studiesUse disorderVaccine technologyLethal overdoseImmunotherapyVaccineLimited treatment accessFentanyl overdoseTreatment access
2021
A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2
Zhang Q, Zhou R, Yang J, Dou C, Gan T, Liu F, Hu B, Song D, Lu C, Hu W. A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2. Infectious Diseases And Therapy 2021, 11: 405-422. PMID: 34878625, PMCID: PMC8651971, DOI: 10.1007/s40121-021-00572-x.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsDrug-related treatment-emergent adverse eventsChinese healthy adultsSingle doseHealthy adultsElimination half-life valuesConclusionsA single doseDifferent dose cohortsPlacebo-controlled trialHuman neutralizing antibodiesYears of ageHuman clinical trialsSARS-CoV-2Monoclonal antibody distributionDose cohortsPlacebo-ControlledAdverse eventsDose proportionalityIntravenous infusionNeutralizing antibodiesBlood creatinineDosage groupsClinical trialsPlaceboPharmacokinetic profile
2020
Utility of spontaneous animal models of Alzheimer’s disease in preclinical efficacy studies
Zeiss CJ. Utility of spontaneous animal models of Alzheimer’s disease in preclinical efficacy studies. Cell And Tissue Research 2020, 380: 273-286. PMID: 32337614, DOI: 10.1007/s00441-020-03198-6.Peer-Reviewed Original ResearchConceptsHuman Alzheimer's diseaseSpontaneous animal modelAlzheimer's diseaseAnimal modelsBiomarker progressionProgression of neuropathologyLate-onset Alzheimer's diseasePreclinical efficacy studiesHuman clinical trialsOnset Alzheimer's diseaseUsable outcome measuresAD-associated mutationsFamilial Alzheimer's diseaseNon-human primatesAmyloid neuropathologyInterventional studyClinical trialsSpontaneous modelHuman trialsOutcome measuresTherapeutic successPotential therapyNew therapiesRodent studiesEfficacy studies
2019
Telavancin-associated acute kidney injury.
Cavanaugh C, Moeckel GW, Perazella MA. Telavancin-associated acute kidney injury. Clinical Nephrology 2019, 91: 187-191. PMID: 30614441, DOI: 10.5414/cn109651.Peer-Reviewed Original ResearchConceptsAcute kidney injuryKidney injuryTubular injuryCases of AKIAcute interstitial nephritisProximal tubular injuryAcute tubular injuryHuman clinical trialsSelect infectionsInterstitial nephritisIntravenous therapyKidney biopsyKidney histopathologyHistologic changesClinical trialsHistopathologic descriptionAnimal modelsLysosomal proliferationTelavancinInjurySemi-synthetic derivativesNumerous phagolysosomesStaphylococciGram-positive bacteriaNephritis
2018
Pathology Study Design, Conduct, and Reporting to Achieve Rigor and Reproducibility in Translational Research Using Animal Models.
Everitt JI, Treuting PM, Scudamore C, Sellers R, Turner PV, Ward JM, Zeiss CJ. Pathology Study Design, Conduct, and Reporting to Achieve Rigor and Reproducibility in Translational Research Using Animal Models. ILAR Journal 2018, 59: 4-12. PMID: 30624739, DOI: 10.1093/ilar/ily020.Peer-Reviewed Original ResearchConceptsAnimal modelsAnimal model-based researchAnimal study dataPreclinical animal modelsHuman clinical experienceHuman clinical trialsPreclinical animal studiesAnimal-based studiesPreclinical animal experimentsPreclinical investigatorsClinical trialsPotential therapyAnimal studiesClinical experiencePathology analysisPathology practiceStudy designAnimal experimentsPathology methodsTranslational researchTissue collectionLimited concordanceComparative pathologistsReproducibility of dataToxicologic Pathology
2017
*Bilateral Arteriovenous Shunts as a Method for Evaluating Tissue-Engineered Vascular Grafts in Large Animal Models
Ong CS, Fukunishi T, Liu RH, Nelson K, Zhang H, Wieczorek E, Palmieri M, Ueyama Y, Ferris E, Geist GE, Youngblood B, Johnson J, Hibino N. *Bilateral Arteriovenous Shunts as a Method for Evaluating Tissue-Engineered Vascular Grafts in Large Animal Models. Tissue Engineering Part C Methods 2017, 23: 728-735. PMID: 28741438, PMCID: PMC6436030, DOI: 10.1089/ten.tec.2017.0217.Peer-Reviewed Original ResearchConceptsLarge animal modelAnimal modelsAcute heart failureHypoxic brain injuryTissue-engineered vascular graftsNon-invasive evaluationHuman clinical trialsVascular graftsArterial pressureGraft patencyHeart failureGraft flowGraft diameterPreclinical dataBrain injuryClinical trialsContralateral sideUltrasound guidancePathological analysisArteriovenous shuntsPreclinical evaluationNeedle punctureInter-subject variabilityImplantation modelGraft
2016
miR-34a Silences c-SRC to Attenuate Tumor Growth in Triple-Negative Breast Cancer
Adams BD, Wali VB, Cheng CJ, Inukai S, Booth CJ, Agarwal S, Rimm DL, Győrffy B, Santarpia L, Pusztai L, Saltzman WM, Slack FJ. miR-34a Silences c-SRC to Attenuate Tumor Growth in Triple-Negative Breast Cancer. Cancer Research 2016, 76: 927-939. PMID: 26676753, PMCID: PMC4755913, DOI: 10.1158/0008-5472.can-15-2321.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerTumor growthMiR-34a replacement therapyTNBC cell linesDifferent TNBC subtypesPromising therapeutic strategyAttenuates tumor growthHuman clinical trialsMiRNA-profiling studiesMiR-34a levelsCell linesPotent antitumorigenic effectsMiR-34a targetsHuman tumor specimensC-SrcReplacement therapyTNBC subtypesAggressive subtypeTreatment optionsClinical trialsDisease progressionEffective therapyPatient outcomesC-Src inhibitor
2015
Multiple Nicotinic Acetylcholine Receptor Subtypes in the Mouse Amygdala Regulate Affective Behaviors and Response to Social Stress
Mineur YS, Fote GM, Blakeman S, Cahuzac EL, Newbold SA, Picciotto MR. Multiple Nicotinic Acetylcholine Receptor Subtypes in the Mouse Amygdala Regulate Affective Behaviors and Response to Social Stress. Neuropsychopharmacology 2015, 41: 1579-1587. PMID: 26471256, PMCID: PMC4832019, DOI: 10.1038/npp.2015.316.Peer-Reviewed Original ResearchConceptsDepression-like behaviorBasolateral amygdalaΑ7 nAChRsCholinergic signalingMultiple nicotinic acetylcholine receptor subtypesNon-selective nAChR antagonist mecamylamineNicotinic acetylcholine receptor activityNicotinic acetylcholine receptor subtypesStress-mediated behaviorsAntidepressant-like effectsAcetylcholine receptor activityC-Fos immunoreactivityNAChR antagonist mecamylamineAcetylcholine receptor subtypesEffects of nicotineMajor depressive disorderSocial defeat stressAnxiety-like behaviorPre-clinical studiesHuman clinical trialsModels of anxietyMouse behavioral modelsHypercholinergic stateAntagonist mecamylamineLocal infusionEmploying a Gain-of-Function Factor IX Variant R338L to Advance the Efficacy and Safety of Hemophilia B Human Gene Therapy: Preclinical Evaluation Supporting an Ongoing Adeno-Associated Virus Clinical Trial
Monahan PE, Sun J, Gui T, Hu G, Hannah WB, Wichlan DG, Wu Z, Grieger JC, Li C, Suwanmanee T, Stafford DW, Booth CJ, Samulski JJ, Kafri T, McPhee SW, Samulski RJ. Employing a Gain-of-Function Factor IX Variant R338L to Advance the Efficacy and Safety of Hemophilia B Human Gene Therapy: Preclinical Evaluation Supporting an Ongoing Adeno-Associated Virus Clinical Trial. Human Gene Therapy 2015, 26: 69-81. PMID: 25419787, PMCID: PMC4326268, DOI: 10.1089/hum.2014.106.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, NeutralizingCapsidClinical Trials as TopicDependovirusDisease Models, AnimalDrug Evaluation, PreclinicalFactor IXGene ExpressionGenetic EngineeringGenetic TherapyGenetic VectorsHemophilia BHemorrhageHumansLiverMaleMiceMice, Inbred C57BLMice, KnockoutRecombinant ProteinsTailTissue DistributionVirionConceptsHuman clinical trialsClinical trialsVector deliveryDose-dependent inflammationAbility of adenoLiver infiltratesMacrovascular thrombosisHemophilic arthropathyClinical morbidityHistopathological findingsMice 8Mild hemophilia BHemophilic miceEfficacy profileNormal micePreclinical studiesIdentical dosesMarked tropismPreclinical evaluationClinical successFIX antibodyTail transectionFIX activityBiodistribution evaluationFunction variants
2014
The role of vitamin D in reducing cancer risk and progression
Feldman D, Krishnan A, Swami S, Giovannucci E, Feldman B. The role of vitamin D in reducing cancer risk and progression. Nature Reviews Cancer 2014, 14: 342-357. PMID: 24705652, DOI: 10.1038/nrc3691.Peer-Reviewed Original ResearchMeSH Keywords25-Hydroxyvitamin D3 1-alpha-HydroxylaseBreast NeoplasmsCalcitriolCholecalciferolColonic NeoplasmsDisease ProgressionEndocrine SystemFemaleHumansMaleNeoplasmsNeoplastic Stem CellsPolymorphism, GeneticPrognosisProstatic NeoplasmsRandomized Controlled Trials as TopicRiskSignal TransductionSteroid HydroxylasesVitamin DVitamin D DeficiencyVitamin D3 24-HydroxylaseConceptsVitamin D receptorReduce cancer riskCancer riskRandomized controlled trialsCancer developmentVitamin D3Vitamin DLow levels of circulating 25(OH)DLevels of circulating 25(OH)DAssociated with increased incidence of cancerCancer stem cell biologySingle nucleotide polymorphismsRisk of cancer developmentAnimal models of cancerAssociated with increased incidenceVitamin D deficiencyVitamin D supplementationLevels of calcitriolSteroid hormone calcitriolHuman clinical trialsRetarding cancer developmentModels of cancerStem cell biologyIncidence of cancerDietary vitamin D3Whole-body biodistribution and dosimetry estimates of a novel radiotracer for imaging of serotonin 4 receptors in brain: [18F]MNI-698
Tavares AA, Caillé F, Barret O, Papin C, Lee H, Morley TJ, Fowles K, Holden D, Seibyl JP, Alagille D, Tamagnan GD. Whole-body biodistribution and dosimetry estimates of a novel radiotracer for imaging of serotonin 4 receptors in brain: [18F]MNI-698. Nuclear Medicine And Biology 2014, 41: 432-439. PMID: 24674817, DOI: 10.1016/j.nucmedbio.2014.02.005.Peer-Reviewed Original ResearchConceptsSerotonin 4 receptorWhole-body biodistributionUrinary bladderDosimetry estimatesOLINDA/EXM 1.0 softwareNovel radiotracersEffective doseMSv/MBqIntravenous bolus injectionWhole-body positron emission tomography (PET) imagesHuman clinical trialsFuture clinical protocolsMain elimination routeAdult rhesus monkeysUrinary bladder modelWhole body weightClinical trialsBolus injectionClinical protocolsNew radiotracersRhesus monkeysCritical organsEffective dosesEmission tomography imagesBladder model
2013
A first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors.
Mateo J, De Bono J, Ramanathan R, Lustberg M, Zivi A, Basset D, Ng M, Young A, Garrett M, Decordova S, Raynaud F, Yap T, Zukiwski A, Proniuk S, Shapiro C. A first-in-human phase I trial of AR-12, a PDK-1 inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2608-2608. DOI: 10.1200/jco.2013.31.15_suppl.2608.Peer-Reviewed Original ResearchPlatelet-rich plasmaAdvanced solid tumorsAR-12PK variabilitySafety dataFood effectSolid tumorsHuman phase I trialAdequate organ functionECOG PS 0Phase II doseDose-escalation studyPhase I trialDrug-related eventsHuman clinical trialsHigh PK variabilityCOX-2 inhibitory activityMechanism of actionBID cohortQD cohortStable diseaseStudy drugPS 0I trialSingle doseA novel human CD1d knock-in mouse model demonstrates potent anti-tumor potential of human CD1d-restricted iNKT cells (P5001)
Yuan W, Wen X, Rao P, Cresswell P, Porcelli S, Kim S, Carreño L, Lawrenczyk A. A novel human CD1d knock-in mouse model demonstrates potent anti-tumor potential of human CD1d-restricted iNKT cells (P5001). The Journal Of Immunology 2013, 190: 110.1-110.1. DOI: 10.4049/jimmunol.190.supp.110.1.Peer-Reviewed Original ResearchINKT cellsHuman iNKT cellsAnti-tumor therapyMouse modelHuman iNKT cell responsesPotent anti-tumor functionsHuman CD1dPowerful anti-tumor effectCD1d antigen presentationFunctional iNKT cellsINKT cell responsesInvariant NKT cellsNKT cell developmentExpression of CD4Conventional mouse modelsAntigen presentation pathwayAnti-tumor functionAnti-tumor effectsHuman clinical trialsAnti-tumor potentialNKT cellsClinical trialsAntigen presentationChallenge modelPreclinical assessmentEpigenetic Therapies in Neurological Diseases
Huang H, Philpot B, Jiang Y. Epigenetic Therapies in Neurological Diseases. Epigenetics And Human Health 2013, 167-193. DOI: 10.1007/978-3-642-36827-1_8.Peer-Reviewed Original ResearchCentral nervous system disordersNervous system disordersCentral nervous systemHuman clinical trialsEpigenetic therapyPeripheral disordersClinical trialsHistone deacetylation inhibitorsSystem disordersTherapeutic strategiesPsychiatric disordersNervous systemUS FoodDrug AdministrationNeurological diseasesTherapeutic interventionsDisease pathophysiologyClinical useTherapyDisordersDeacetylation inhibitorsSuitable targetEpigenetic abnormalitiesEpigenetic modifiersCurrent understandingPanel 6: Vaccines
Pelton SI, Pettigrew MM, Barenkamp SJ, Godfroid F, Grijalva CG, Leach A, Patel J, Murphy TF, Selak S, Bakaletz LO. Panel 6: Vaccines. Otolaryngology 2013, 148: e90-e101. PMID: 23536534, PMCID: PMC4029613, DOI: 10.1177/0194599812466535.Peer-Reviewed Original ResearchConceptsAcute otitis mediaPneumococcal conjugate vaccineOtitis mediaDevelopment of correlatesCandidate antigensAnimal modelsClinical efficacy trialsEffectiveness of vaccinesBurden of diseaseNontypeable Haemophilus influenzaeHuman clinical trialsOtitis pathogensConjugate vaccineVaccine strategiesPneumococcal serotypesClinical trialsMoraxella catarrhalisAdditional serotypesNew adjuvantsEfficacy trialsObservational studyFrequent recurrenceChild healthVaccine antigensMore antigens
2011
Pharmaceutical formulation affects titanocene transferrin interactions
Buettner K, Snoeberger R, Batista V, Valentine A. Pharmaceutical formulation affects titanocene transferrin interactions. Dalton Transactions 2011, 40: 9580-9588. PMID: 21847473, DOI: 10.1039/c1dt10805k.Peer-Reviewed Original ResearchConceptsTitanocene dichlorideHuman serum transferrinUV/FT-ICR mass spectrometryMolar absorptivityPH-dependent speciationDifferent molar absorptivitiesDFT calculationsSynergistic anionFluorescence quenchingPharmaceutical formulationsMass spectrometryTransfer energyAnticancer activitySerum transferrinAnticancer drugsPhase II human clinical trialsAbsorptivityNMRAnionsHuman clinical trialsDichloridePotential vehicleSpectrometryTi
2010
Phase I Dose-Escalation Study of Recombinant Human Apo2L/TRAIL, a Dual Proapoptotic Receptor Agonist, in Patients With Advanced Cancer
Herbst RS, Eckhardt SG, Kurzrock R, Ebbinghaus S, O'Dwyer PJ, Gordon MS, Novotny W, Goldwasser MA, Tohnya TM, Lum BL, Ashkenazi A, Jubb AM, Mendelson DS. Phase I Dose-Escalation Study of Recombinant Human Apo2L/TRAIL, a Dual Proapoptotic Receptor Agonist, in Patients With Advanced Cancer. Journal Of Clinical Oncology 2010, 28: 2839-2846. PMID: 20458040, DOI: 10.1200/jco.2009.25.1991.Peer-Reviewed Original ResearchConceptsRecombinant human Apo2L/TRAILRhApo2L/TRAILDose-escalation studyAdverse eventsAdvanced cancerLiver metastasesDose escalationLiver functionApo2L/TRAILI dose-escalation studyDurable partial responseRapid tumor necrosisAntitumor activityCommon adverse eventsLiver enzyme elevationMetastatic liver diseaseSerious adverse eventsAbnormal liver functionNormal liver functionMultiple intravenous dosesNecrosis factor-related apoptosis-inducing ligandPreclinical antitumor efficacyTumor necrosis factor-related apoptosis-inducing ligandFactor-related apoptosis-inducing ligandHuman clinical trials
1998
Intrastriatal Grafts From Multiple Donors Do Not Result in a Proportional Increase in Survival of Dopamine Neurons in Nonhuman Primates
Sladek J, Collier T, Elsworth J, Roth R, Taylor J, Redmond D. Intrastriatal Grafts From Multiple Donors Do Not Result in a Proportional Increase in Survival of Dopamine Neurons in Nonhuman Primates. Cell Transplantation 1998, 7: 87-96. DOI: 10.1016/s0963-6897(98)00007-4.Peer-Reviewed Original ResearchConceptsDopamine neuronsDouble graftsAdult African green monkeysVentral mesencephalic dopamine neuronsMultiple donorsGrafts of tissueMore dopamine neuronsSymptoms of parkinsonismMesencephalic dopamine neuronsDopamine cell survivalHuman clinical trialsAfrican green monkeysIntrastriatal graftsPositive neuronsTotal numberClinical trialsDopamine levelsCaudate nucleusRecipient animalsGraftGrafted tissueNeuronsGreen monkeysNonhuman primatesDorsoventral extentIntrastriatal Grafts from Multiple Donors do not Result in a Proportional Increase in Survival of Dopamine Neurons in Nonhuman Primates
Sladek J, Collier T, Elsworth J, Roth R, Taylor J, Redmond D. Intrastriatal Grafts from Multiple Donors do not Result in a Proportional Increase in Survival of Dopamine Neurons in Nonhuman Primates. Cell Transplantation 1998, 7: 87-96. PMID: 9588591, DOI: 10.1177/096368979800700204.Peer-Reviewed Original ResearchConceptsDopamine neuronsDouble graftsAdult African green monkeysVentral mesencephalic dopamine neuronsMultiple donorsGrafts of tissueMore dopamine neuronsSymptoms of parkinsonismMesencephalic dopamine neuronsDopamine cell survivalHuman clinical trialsAfrican green monkeysIntrastriatal graftsPositive neuronsTotal numberClinical trialsDopamine levelsCaudate nucleusRecipient animalsGraftGrafted tissueNeuronsGreen monkeysNonhuman primatesDorsoventral extent
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply