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IL-10NanoCap® for Therapy of Familial Adenomatous Polyposis
NIHUS FederalResearch GrantFY2025AmericanApcMin/+ApcMin/+ miceAttenuatedAutoregulationAwardB fragilisB. fragilisBacteroides fragilisBioequivalenceBiologic SciencesBiologicalBiological SciencesBioscienceBlood SerumCSIFCSIF-10ClinicalClinical EquivalencyClinical ProtocolsClinical TrialsColectomyCollaborationsColonColon CancerColon CarcinomaColorectal CancerCrab-Eating MacaqueCrab-Eating MonkeyCynomolgus MonkeyCynomolgus macaqueCytokine Synthesis Inhibitory FactorDevelopmentDevelopment PlansDominant Genetic ConditionsDominant traitDoseDrug KineticsDrugsFamilial Adenomatous Polyposis SyndromeFamilial Polyposis SyndromeFood, Drug and Cosmetic ActFormulationFundingFutureGeneric EquivalencyGenetic DiseasesGenetic DominantGrantHomeostasisIL-10IL10IL10AImmuneImmune signalingImmunesIndustry StandardInterleukin 10 PrecursorInterleukin-10Intestinal PolyposisInvestigational DrugsInvestigational New DrugsLifeLife SciencesLightLong-Term EffectsM fascicularisM. fascicularisMacaca cynomolgusMacaca fascicularisMacaca irusMedicationMethodsMonkeysNational Institutes of HealthNew Drug ApprovalsOncogenesisOralOral AdministrationOral Drug AdministrationOrphanOrphan DiseaseOrphan DrugsParticulatePatientsPharmaceutical AgentPharmaceutical PreparationsPharmaceuticalsPharmacokineticsPharmacologic SubstancePharmacological SubstancePhasePhotoradiationPhysiological HomeostasisPre IND FDA meetingPre-IND mtgPreparationPreparednessProcessProductionProgram DevelopmentPublishingRare DiseasesRare DisorderReadinessRecommendationRecoveryRectumSBIRSafetySerumSmall Business Innovation ResearchSmall Business Innovation Research GrantSpecific qualifier valueSpecifiedStructureSuggestionTherapeuticTherapeutic EquivalencyToxic effectToxicitiesToxicologyTreatment ProtocolsTreatment RegimenTreatment ScheduleUnited States National Institutes of HealthValidationWorkadenomaattenuateattenuatesautosomebiologiccancer in the coloncancer progressionclinical developmentclinical relevanceclinically relevantcommercial scale manufacturingcommercialization readinesscomparativecytokinedesigndesigningdevelopmentaldrug bioequivalencedrug bioequivalentdrug developmentdrug/agentfamilial adenomatous polyposisfamilial polyposisgenetic conditiongenetic disorderhuman modelintraoral drug deliverylong-tailed macaquemanufacturemanufacturing processmanufacturing ramp-upmanufacturing scale-upmeetingmeetingsmodel of humanmouse modelmurine modelneoplasm progressionneoplastic progressionnew drug treatmentsnew drugsnew pharmacological therapeuticnew therapeuticsnew therapynext generation therapeuticsnon-human primatenonhuman primatenovel drug treatmentsnovel drugsnovel pharmaco-therapeuticnovel pharmacological therapeuticnovel therapeuticsnovel therapyorphan disorderpharmaceuticalpre-IND consultationpre-IND discussionpre-IND meetingpre-Investigational New Drug meetingpre-clinicalpre-clinical developmentpreclinicalpreclinical developmentpreparationsproduct developmentprogramspublic health relevanceresponsescale upscale up batchscale up productionsuccesstherapy optimizationtreatment optimizationtumor progressiontumorigenesisupscale manufacturingvalidations
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Description preview
Abstract
This SBIR Phase IIb proposal builds on the success of our Fast-track award supporting the pre-clinical
development of FAPXIL, an oral sustained-release micro-particulate formulation of Interleukin-10 for the
treatment of Familial Adenomatous Polyposis (FAP). The Phase I portion of our Fast-track project provided
validation of our…
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