Engineered Biotherapeutic Agent for Treatment of Post-Traumatic Osteoarthritis
用于治疗创伤后骨关节炎的工程生物治疗剂
基本信息
- 批准号:10821518
- 负责人:
- 金额:$ 13.73万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-25 至 2025-08-31
- 项目状态:未结题
- 来源:
- 关键词:AccelerationAcuteAddressAdverse effectsAdverse eventAffectAmericanAnimal ModelAnimalsAnterior Cruciate LigamentAnti-Inflammatory AgentsArthralgiaArthritisBehaviorBiocompatible MaterialsBiodistributionBiological ProductsBiological Response Modifier TherapyCarrier ProteinsCartilageCartilage DiseasesCircular DichroismDegenerative DisorderDegenerative polyarthritisDevelopmentDisease ProgressionDoseEngineeringExhibitsGaitGelGoalsGrowth FactorHydrogelsHydrogenIn SituInflammatoryInjectableInjuryIntra-Articular InjectionsInvestigationJoint InstabilityJointsLife ExpectancyMarketingMechanicsMicellesModelingMolecular StructureOperative Surgical ProceduresOryctolagus cuniculusOutcomePainPatientsPharmaceutical PreparationsPhasePhysiciansPhysiologicalPreparationPreventionPreventive carePreventive treatmentPropertyProtein EngineeringProteinsPublic HealthRattusReconstructive Surgical ProceduresReplacement ArthroplastyReproducibilityRheologySalineScanning Electron MicroscopySecond Look SurgerySmall Business Technology Transfer ResearchStructureSystemTNF geneTemperatureTherapeuticTherapeutic EffectTimeToxic effectToxicologyTraumaTraumatic ArthropathyTraumatic injuryTreatment CostWeightanterior cruciate ligament rupturearthropathiesarticular cartilagebiopharmaceutical industrycartilage degradationcartilage repairchondroprotectioncommercial applicationcytokinedensitydisabilityexperienceexperimental groupfirst-in-humangood laboratory practicehuman diseasejoint inflammationjoint injurylight scatteringminimally invasivenovelpoint of carepoint of injurypre-clinicalpreclinical studypreservationpreventproduct developmentviscoelasticity
项目摘要
PROJECT SUMMARY/ABSTRACT
Post-traumatic osteoarthritis (PTOA) is a degenerative disease of cartilage brought on by traumatic injury to
the articular joints. Acute joint injury is followed by severe joint pain and inflammation. This results in much
more rapid degeneration of cartilage than in other forms of osteoarthritis, due to the joint instability caused by
trauma as well as the increase in proinflammatory cytokines that accelerate degeneration. PTOA affects 5.6
million Americans, with an estimated $11.79 billion associated with direct treatment costs for its treatment.
There are no approved treatments that stop or alter the progression of the disease, and complete degeneration
of the articular cartilage can necessitate joint replacement surgery. This may require surgical revision in
approximately 10 years, a particularly undesirable outcome in younger patients with longer life expectancies.
ProViZiGen has developed a novel protein-engineered injectable therapeutic hydrogel system, HydroGEN that
forms a gel when injected into the joint space and provides sustained delivery of an anti-inflammatory and
chondroprotective therapeutic molecule. Our recent preclinical investigation in a rabbit anterior cruciate
ligament (ACL) transection model has shown that immediate delivery of HydroGEN significantly prevents the
development of PTOA after joint injury and delivery 8 weeks after the point of injury has therapeutic effects
promoting endogenous cartilage repair. In this Phase I STTR, we aim to determine stability and lack of toxicity
of HydroGEN to establish functional gelation and establish safe dosing. In Aim I, we will determine the stability
and mechanics of HydroGEN by assessing the protein’s microstructure and macrostructure, as well as its
rheologic properties as a function of temperature and time to determine its functionality as an in situ gelling
injectable therapeutic. In Aim II, we will establish the lack of toxicity and selective biodistribution of HydroGEN
in a rat model of intraarticular injection. Successful completion of these aims will prepare ProViZiGen for filing a
BLA with the FDA, with large animal PTOA model investigation (Phase II) leading to first in human trials.
项目总结/文摘
项目成果
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