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: 10470633
• 负责人: Donald Lo
• 金额: $ 110.47万
• 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/10470633
• 关键词: ADME Study; Abdominal Pain; Anatomy; Biological; 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

最佳的主要研究人员开发了肿瘤渗透微粒（TPMS），这是一种针对腹膜腔独特的解剖学特性量身定制的一流递送系统。 TPM是多功能，多功能，生物相容性，可生物降解，可控的聚合物微米大小的颗粒。 TPM旨在靶向，穿透和输送药物动力学优化的药物水平到腹膜肿瘤的浅层和深层。 TPM代表一个可用于输送小分子疗法，生物制剂，基因载体和成像剂的输送平台。第一代TPM TPM001载有紫杉醇，并带有胰腺癌作为第一个指示。目的是开发有效的治疗方法，以控制转移性胰腺癌和更普遍的腹膜肿瘤。 Bridgs团队已在完成TPM001的以下研究中取得了进步： - 制造良好的制造实践（GMP）药品 - 制定开发 - 药代动力学/吸收，分布，代谢和排泄（PK/ADME）研究 - 调查新药（IND）指导的毒理学