ENZYME THERAPY FOR DISEASES INVOLVING ACTIVE OXYGEN

涉及活性氧的疾病的酶疗法

• 批准号: 3508471
• 负责人: ABRAHAM ABUCHOWSKI
• 金额: $ 22.26万
• 依托单位: ENZON, INC.
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-09-30 至 1989-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3508471
• 关键词: burns; clinical trials; dosage; drug adverse effect; drug delivery systems; drug interactions; drug tolerance; enzyme therapy; human subject; human therapy evaluation; hydrogen peroxide; hydroxyl group; intravenous administration; kidney transplantation; pharmacology; polyethylenes; renal ischemia /hypoxia; superoxide dismutase; superoxides; trauma

The enzyme superoxide dismutase (SOD) has been modified by the covalent attachment of monomethoxypolyethylene glycol (PEG) to form the conjugate PEG-SOD with greatly improved pharmacokinetics and clinically insignificant immunogenicity. Phase I trials have been completed in human volunteers with no adverse effects reported. PEG-SOD will be in evaluated in Phase II clinical trials for three indications: kidney transplants, burns, and multiple trauma. On completion of Phase II trials, we will move to Phase III trials for these indications.

超氧化物歧化酶（SOD）已被修饰， 共价连接单甲氧基聚乙二醇（PEG）以形成 具有大大改善的药代动力学的缀合物PEG-SOD， 临床上不显著的免疫原性。 I期试验已经 在人类志愿者中完成，未报告不良反应。 PEG-SOD将在II期临床试验中进行评估， 适应症：肾移植、烧伤和多发性创伤。 对 完成第二阶段试验后，我们将进入第三阶段试验 对于这些迹象。