New stimulator for chronic wound healing-Phase II

新型慢性伤口愈合刺激器-第二阶段

• 批准号: 7055908
• 负责人: HUI ZHAO
• 金额: $ 26.2万
• 依托单位: SUNNY BIODISCOVERY, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7055908
• 关键词: biological signal transduction; diabetes mellitus; dosage; drug metabolism; drug screening /evaluation; high performance liquid chromatography; laboratory mouse; laboratory rabbit; laboratory rat; mass spectrometry; medicinal plants; nitric oxide; nitric oxide synthase; nuclear magnetic resonance spectroscopy; pharmacokinetics; regeneration; stimulant /agonist; swine; tensile strength; tissue mosaicism; toxicology; wound healing

DESCRIPTION (provided by applicant): Our society becomes increasingly vulnerable to chronic wounds as we age and become more obese. Despite that, efficient, inexpensive and simple-to-apply wound-healing drugs are presently unavailable. Here, we initiated the development of such a drug. In Phase I we demonstrated the superior wound-healing activity of a collagen-, fibroblast- and angiostimulatory compound isolated in our lab from a medicinal plant used for chronic wound treatment. The bioactivity of this compound has been validated in healing-impaired diabetic mice and in wounded human skin graft/mouse chimeras. Furthermore, the preliminary safety studies showed that the topical application of this product may be safe. In this Phase II project we propose to a) establish the optimal bioactive dose of this compound using rodent and rabbit wound-healing models; b) demonstrate in rodents, rabbits and swines that this compound is more efficient than the wound-healing prescription drug currently used in clinic; c) demonstrate that this drug- candidate not only does stimulate wound healing, but also results in greater tensile strength of the healed tissue, d) validate its safety in a series of PK/ADME/Toxicology tests. Together, the proposed experiments should confirm the therapeutic potential of this novel wound-healing compound and advance its development towards the IND application.

描述（由申请人提供）：随着年龄的增长，我们的社会变得越来越容易受到慢性伤口的影响。尽管如此，目前仍无法使用高效，廉价且易于伤口治疗的药物。在这里，我们启动了这种药物的开发。在第一阶段，我们证明了胶原蛋白，成纤维细胞和血管刺激化合物的优质伤口愈合活性，该化合物从用于慢性伤口治疗的药物中分离出来。该化合物的生物活性在愈合受损的糖尿病小鼠和受伤的人类皮肤移植/小鼠嵌合体中得到了验证。此外，初步安全研究表明，该产品的局部应用可能是安全的。在此II阶段项目中，我们建议a）使用啮齿动物和兔伤口控制模型建立该化合物的最佳生物活性剂量； b）在啮齿动物，兔子和猪中证明，这种化合物比目前在诊所中使用的伤口治疗处方药更有效。 c）证明，该药物不仅会刺激伤口愈合，而且会导致愈合组织的拉伸强度更大，d）在一系列PK/ADME/毒理学测试中验证其安全性。共同提出的实验应确认这种新型伤口治疗化合物的治疗潜力，并将其发展为IND应用。