Studies of Tumor-Penetrating Microparticles for Pancreatic Cancer
Studies of Tumor-Penetrating Microparticles for Pancreatic Cancer
批准号:
10910752
负责人:
Elizabeth Ottinger
金额:
$144.65万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
Abdominal PainAnatomyBiological ProductsClinicalClinical ResearchClinical TrialsFormulationGenerationsGenesGoalsGreater sac of peritoneumIndwelling CatheterInfectionIntercellular FluidIntravenousLeadMalignant neoplasm of pancreasOncologyOral AdministrationPaclitaxelParticle SizePatientsPenetrationPeritonealPharmaceutical PreparationsPharmacodynamicsPharmacologic SubstancePolymersPropertyResearch PersonnelSolid NeoplasmSystemSystemic TherapyToxic effectToxicologyWorkbiomaterial compatibilityblood perfusioncontrolled releasedesigneffective therapyimaging agentintraperitonealintraperitoneal therapyintravenous administrationmanufactureparticlepressurepreventrandomized trialsmall molecule therapeuticstumorvector
中文摘要
Optimum的主要研究人员开发了肿瘤穿透微粒(TPMs),这是一种针对腹膜腔独特解剖特性量身定制的一流输送系统。TPM是多组分、多功能、生物相容性、生物可降解、控释聚合物微米级颗粒。TPM设计用于靶向、渗透和递送药效学优化的药物水平至腹膜肿瘤的浅表层和深层。TPM代表可用于递送小分子治疗剂、生物制剂、基因载体和成像剂的递送平台。第一代TPM,TPM 001,装载紫杉醇,胰腺癌作为第一适应症。
BrIDGs团队已经完成了PK/ADME和IND指导的毒理学研究,并开发和制造了一种临床级药物产品,合作者将其纳入了成功的IND申请中,以启动临床试验。BrIDGs团队正在进行额外的配方和生产工作,以支持正在进行的临床研究。
英文摘要
The lead investigators at Optimum developed tumor-penetrating microparticles (TPMs), a first-in-class delivery system tailored to the unique anatomical properties of the peritoneal cavity. TPMs are multicomponent, multifunctional, biocompatible, biodegradable, controlled-release polymeric micron-size particles. TPMs are designed to target, penetrate and deliver pharmacodynamically optimized drug levels to the superficial and deep layers of peritoneal tumors. TPMs represent a delivery platform that can be used to deliver small molecule therapeutics, biologics, gene vectors and imaging agents. The first generation TPM, TPM001, is loaded with paclitaxel, with pancreatic cancer as the first indication.
The BrIDGs team has completed PK/ADME and IND-directed toxicology studies, and developed and manufactured a clinical grade drug product, which the collaborators included in a successful IND application to initiate clinical trials. The BrIDGs team is conducting additional formulation and manufacturing work to support the ongoing clinical studies.
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