Complement Inhibitors for Macular Degeneration
黄斑变性的补体抑制剂
基本信息
- 批准号:7612275
- 负责人:
- 金额:$ 21.21万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2009
- 资助国家:美国
- 起止时间:2009-02-15 至 2011-02-14
- 项目状态:已结题
- 来源:
- 关键词:AdultAffectAge related macular degenerationAlternative Complement PathwayAnaphylatoxinsAnimal ModelAnimalsAntibodiesAreaBindingBlindnessBloodBlood PlateletsBlood VesselsCell LineChoroidal NeovascularizationClassical Complement PathwayClinical DataClinical TrialsCollaborationsComplement 3aComplement 5aComplement ActivationComplement Factor BComplement InactivatorsComplement Membrane Attack ComplexDepositionDevelopmentDiseaseDisease modelDrusenElastasesEvaluationEyeEye diseasesFDA approvedFoundationsGene SilencingGenesHandHost DefenseHumanIn VitroInflammation MediatorsInflammatoryInflammatory ResponseInjection of therapeutic agentLaboratoriesLeadLegal patentLucentisMacular degenerationMarketingMediatingMedicalModelingMonoclonal AntibodiesMusNamesNeutrophil ActivationOryctolagus cuniculusPathologyPathway interactionsPharmaceutical PreparationsPhasePlayPopulationProductionProphylactic treatmentProteinsResearchRoleSafetySmall Interfering RNAStudentsSymptomsTNF geneTechniquesTestingTherapeuticToxic effectTumor Necrosis Factor-alphaVascular Endothelial Growth FactorsVisitWorkangiogenesisaptamerbasebevacizumabclinically relevantcomplement pathwaydrug testingexperiencehuman TNF proteinhuman TYRP1 proteinhumanized antibodyhumanized monoclonal antibodiesimmunogenicityin vivoinhibitor/antagonistmeetingsmonocytemouse modelneutralizing monoclonal antibodiesneutrophilpreventprogramsprophylacticpublic health relevanceresearch studysuccess
项目摘要
DESCRIPTION (provided by applicant): Age-related macular degeneration (AMD) affects nearly 10 million people in the U.S (Research to Prevent Blindness Foundation). Recently approved anti-VEGF therapy is the only cure for wet AMD as of today. Recent studies have demonstrated the role of the alternative pathway (AP) in AMD. Gradual loss of vision eventually resulting in blindness is the key symptom of AMD in the adult population. Using the mouse AMD model, Bora et al demonstrated that complement factor B of the alternative pathway plays an important role in the disease. With the use of siRNA techniques, Dr. Bora demonstrated that silencing of the factor B gene prevents the induction and persistence of AMD. Encouraged by these results, we decided to evaluate the effect of our blocking anti-factor B monoclonal antibody (Bikaciomab) in inhibiting the development and progression of AMD. Bikaciomab binds factor B protein in human blood and blocks its function in AP mediated complement activation. Bikaciomab prevents alternative pathway mediated formation of C3a, C5a, and C5b-9, the key anaphylatoxins responsible for the inflammatory responses. We will test the effect of this blocking anti-factor B antibody in prophylaxis and established models of the disease to provide direct clinical relevance of the drug under testing. PUBLIC HEALTH RELEVANCE: Age-related macular degeneration (AMD) affects nearly 10 million people in the U.S (Research to Prevent Blindness Foundation). Recently approved anti-VEGF therapy is the only cure for wet AMD as of today. There is an unmet medical need in the area of macular degeneration. NovelMed's current approach focuses on neutralizing factor B function and providing disease benefit. Using the previously developed animal models of AMD, NovelMed intends to test its lead complement inhibitor for the treatment of AMD. Potent activity of Bikaciomab in vitro, ex vivo and in vivo makes the drug as a potential therapeutic for not only AMD but also for several diseases where alternative pathway plays an important role in disease pathology.
描述(由申请人提供):年龄相关性黄斑变性 (AMD) 影响着美国近 1000 万人(防盲研究基金会)。最近批准的抗 VEGF 疗法是迄今为止治疗湿性 AMD 的唯一方法。最近的研究证明了替代途径 (AP) 在 AMD 中的作用。视力逐渐丧失最终导致失明是成年人群 AMD 的主要症状。 Bora 等人利用小鼠 AMD 模型证明了旁路途径的补体因子 B 在该疾病中发挥着重要作用。通过使用 siRNA 技术,Bora 博士证明 B 因子基因的沉默可以防止 AMD 的诱导和持续。受到这些结果的鼓舞,我们决定评估我们的阻断性抗 B 因子单克隆抗体 (Bikaciomab) 在抑制 AMD 发生和进展方面的效果。 Bikaciomab 结合人血液中的 B 因子蛋白并阻断其在 AP 介导的补体激活中的功能。 Bikaciomab 可防止旁路途径介导的 C3a、C5a 和 C5b-9 的形成,C3a、C5a 和 C5b-9 是导致炎症反应的关键过敏毒素。我们将测试这种阻断性抗因子 B 抗体在预防中的效果并建立疾病模型,以提供所测试药物的直接临床相关性。公共健康相关性:年龄相关性黄斑变性 (AMD) 影响着美国近 1000 万人(防盲研究基金会)。最近批准的抗 VEGF 疗法是迄今为止治疗湿性 AMD 的唯一方法。黄斑变性领域的医疗需求尚未得到满足。 NovelMed 目前的方法侧重于中和 B 因子功能并提供疾病益处。 NovelMed 打算使用先前开发的 AMD 动物模型来测试其先导补体抑制剂对 AMD 的治疗作用。 Bikaciomab 在体外、离体和体内的有效活性使得该药物不仅可以作为 AMD 的潜在治疗剂,还可以作为替代途径在疾病病理学中发挥重要作用的多种疾病的潜在治疗剂。
项目成果
期刊论文数量(0)
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Rekha Bansal其他文献
Rekha Bansal的其他文献
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{{ truncateString('Rekha Bansal', 18)}}的其他基金
Disease Modifying Treatment for Hemolytic Disorders
溶血性疾病的疾病修饰治疗
- 批准号:
10254750 - 财政年份:2021
- 资助金额:
$ 21.21万 - 项目类别:
Preclinical and Clinical Evaluation of Humanized NM9405
人源化NM9405的临床前和临床评价
- 批准号:
8647587 - 财政年份:2014
- 资助金额:
$ 21.21万 - 项目类别:
Preclinical and Clinical Evaluation of Humanized NM9405
人源化NM9405的临床前和临床评价
- 批准号:
8925257 - 财政年份:2014
- 资助金额:
$ 21.21万 - 项目类别:
Preclinical and Clinical Evaluation of Humanized NM9405
人源化NM9405的临床前和临床评价
- 批准号:
9038429 - 财政年份:2014
- 资助金额:
$ 21.21万 - 项目类别:
Alternative Pathway Inhibitors for Orphan Indication
用于孤儿适应症的替代途径抑制剂
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8524040 - 财政年份:2013
- 资助金额:
$ 21.21万 - 项目类别:
Alternative Pathway Inhibitors for Orphan Indication
用于孤儿适应症的替代途径抑制剂
- 批准号:
8883970 - 财政年份:2013
- 资助金额:
$ 21.21万 - 项目类别:
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