grant
Translational studies to advance Filociclovir to IND submission for the treatment of adenoviral conjunctivitis and acute keratoconjunctivitis
NIHUS FederalResearch GrantFY20262-Pyrrolidinone, 1-ethenyl-, homopolymerAccountingActive Follow-upAcuteAdenoviridaeAdenoviridae InfectionsAdenovirus InfectionsAdenovirusesAdverse effectsAnimalsArtificial TearsAustraliaBehavioralBlindnessCMV infectionCanine SpeciesCanis familiarisCardiovascularCardiovascular Body SystemCardiovascular Organ SystemCardiovascular systemChemistryChronicCidofovirClinicalClinical ResearchClinical StudyClinical TrialsClinical Trials DesignCommon Rat StrainsCommunicationConjunctivitisCorneaCytomegalic Inclusion DiseaseCytomegalovirus InfectionsDataDevicesDiseaseDisorderDogsDogs MammalsDomestic RabbitDoseDrug KineticsDrug TherapyEarly-Stage Clinical TrialsEconomic BurdenEnzyme GeneEnzymesEpidemic KeratoconjunctivitisExhibitsEyeEye DropsEye InfectionsEyeballEyedropsFDA licensed drugsFDA-approved agentsFDA-approved drugFDA-approved medicationsFDA-approved pharmaceuticalsFDA-approved therapeutic agentFood and Drug Administration approved drugFood and Drug Administration approved medicationsFood and Drug Administration approved pharmaceuticalsFormulationGelGoalsHPMPCHeart VascularHumanIND FilingIND applicationIND packageIND submissionInclusion DiseaseIndiaInfectionInvestigational DrugsInvestigational New Drug ApplicationInvestigational New DrugsIodineKeratitisKeratoconjunctivitisMedicalModelingModern ManNOAELNSAIDsNational Eye InstituteNeurologicNeurologicalNo-Observed-Adverse-Effect LevelNon-Steroidal Anti-Inflammatory AgentsOcular InfectionsOryctolagus cuniculusP-30 ProteinP30 ProteinPancreatic RNasePancreatic ribonucleasePathologyPatientsPharmacokineticsPharmacological TreatmentPharmacologyPharmacology and ToxicologyPharmacotherapyPhasePhase 1 Clinical TrialsPhase 2 Clinical TrialsPhase I Clinical TrialsPhase II Clinical TrialsPolvidonePolyvidonPolyvinylpyrrolidonePositionPositioning AttributePovidonePre IND FDA meetingPre-IND mtgPreclinical dataPrimary Care PhysicianRNase ARNase IRabbitsRabbits MammalsRatRats MammalsRattusReactionRegimenResearch DesignResearch PriorityRibonuclease ARibonuclease ISafetySalivary Gland Virus DiseaseSolidSpecific qualifier valueSpecifiedStudy TypeSupportive TherapySupportive careTopical CorticosteroidsToxicologyUnited StatesViral ActivityViral BurdenViral FunctionViral LoadViral Load resultViral PhysiologyViral SheddingVirus SheddingVisitVisualWorkactive followupanti-microbialantimicrobialcaninecarcinogenicitycirculatory systemconjunctivacornealdecreased incomedomestic dogdrug interventiondrug treatmenteffective therapyeffective treatmenteffectiveness testingefficacy studyfollow upfollow-upfollowed upfollowupgenotoxicityimprove symptomincome lossinhibitorlost earninglost incomelost wagemanufacturemeetingmeetingsmeternew drug treatmentsnew drugsnew pharmacological therapeuticnew therapeuticsnew therapynext generation therapeuticsnon-steroidal anti-inflammatory drugsnovelnovel drug treatmentsnovel drugsnovel pharmaco-therapeuticnovel pharmacological therapeuticnovel therapeuticsnovel therapynucleoside analogorgan transplant patientorgan transplant recipientpharmaceutical interventionpharmacological interventionpharmacological therapypharmacology interventionpharmacology treatmentpharmacotherapeuticsphase 2 studyphase I protocolphase II protocolphase II studypre-IND consultationpre-IND discussionpre-IND meetingpre-Investigational New Drug meetingpre-clinicalpre-clinical developmentpre-clinical studypreclinicalpreclinical developmentpreclinical findingspreclinical informationpreclinical studyprogramsranpirnasereduced incomerespiratorysafety studysocio-economicsocio-economicallysocioeconomicallysocioeconomicsstudy designsymptom improvementsymptomatic improvementtranslational studyvision lossvisual loss
Description preview
Project Summary/Abstract
The long-term goal of this project, to develop filociclovir (FCV) for the safe and effective
treatment of human adenovirus (HAdV) ocular infections, especially HAdV-related epidemic
keratoconjunctivitis (EKC), a stated National Eye Institute (NEI) research priority. There are
currently no treatments for patients suffering…
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