Studies of Tumor-Penetrating Microparticles for Pancreatic Cancer

肿瘤穿透微粒治疗胰腺癌的研究

• 批准号: 10685882
• 负责人: Donald Lo
• 金额: $ 154.65万
• 依托单位: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10685882
• 关键词: ADME Study; Abdominal Pain; Anatomy; Biological Products; Development; Drug Kinetics; Formulation; Generations; Genes; Goals; Greater sac of peritoneum; Indwelling Catheter; Infection; Intercellular Fluid; Intravenous; Investigational Drugs; Lead; Malignant neoplasm of pancreas; Oncology; Oral Administration; Paclitaxel; Particle Size; Patients; Penetration; Peritoneal; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Polymers; Property; Research Personnel; Solid Neoplasm; System; Systemic Therapy; Toxic effect; Toxicology; biomaterial compatibility; blood perfusion; controlled release; design; effective therapy; imaging agent; intraperitoneal; intraperitoneal therapy; pressure; prevent; randomized trial; small molecule therapeutics; tumor; vector

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 goal is to develop an effective treatment for locoregional control of metastatic pancreatic cancer and, more generally, peritoneal tumors. The BrIDGs team has made progress towards the completion of the following studies on TPM001: - Manufacture of Good Manufacturing Practice (GMP) drug product - Formulation development - Pharmacokinetic/absorption, distribution, metabolism, and excretion (PK/ADME) studies - Investigational New Drug (IND)-directed toxicology

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。目的是开发一种有效的治疗方法，用于转移性胰腺癌的局部控制，更一般地说，腹膜肿瘤。 BrIDG小组在完成以下关于TPM 001的研究方面取得了进展： - 药品生产质量管理规范（GMP）制剂的生产 - 处方开发 - 药代动力学/吸收、分布、代谢和排泄（PK/ADME）研究 - 研究性新药（IND）导向毒理学