New stimulator for chronic wound healing-Phase II

描述（由申请人提供）：随着年龄的增长和肥胖的增加，我们的社会越来越容易受到慢性创伤的影响。尽管如此，目前还没有有效、廉价和易于应用的伤口愈合药物。在这里，我们开始了这种药物的开发。在第一阶段，我们证明了上级的伤口愈合活性的胶原蛋白，成纤维细胞和血管刺激化合物分离在我们的实验室从药用植物用于慢性伤口治疗。该化合物的生物活性已在愈合受损的糖尿病小鼠和受伤的人皮肤移植物/小鼠嵌合体中得到验证。此外，初步安全性研究表明，本品的局部应用可能是安全的。在该II期项目中，我们建议a）使用啮齿动物和兔伤口愈合模型建立该化合物的最佳生物活性剂量; B）在啮齿动物、兔和猪中证明该化合物比目前临床上使用的伤口愈合处方药更有效; c）证明该候选药物不仅刺激伤口愈合，而且导致愈合组织的更大拉伸强度，d）在一系列PK/ADME/毒理学测试中验证其安全性。总之，拟议的实验应该证实这种新型伤口愈合化合物的治疗潜力，并推动其向IND应用的发展。

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.