Evaluation of a novel connexin-based peptide for the treatment of diabetic wounds

描述（由申请人提供）：根据美国糖尿病协会，在美国有超过1600万人患有已知的糖尿病。糖尿病患者通常表现为伤口愈合受损。大约20%的糖尿病患者会在一生中患上足部溃疡。糖尿病足溃疡（DFU）是严重影响患者生活质量的主要问题，需要长期住院治疗，并可能涉及感染、坏疽和截肢。据估计，一名中年糖尿病男子在头两年每出现一次新的足部溃疡，可归因的费用约为3万美元。在美国，医疗系统每年在DFU上的花费超过10亿美元。糖尿病伤口难以愈合的一个公认的原因是，它们没有经过正常的愈合阶段。相反，人们认为糖尿病伤口被捕获并保持在伤口愈合的初始炎症阶段。FirstString Research, Inc. （FSR）是一家位于南卡罗来纳州查尔斯顿的生物技术公司。FSR的创始人，dr。Robert Gourdie和Gautam Ghatnekar是一类新型生物工程肽的共同发明者-我们称之为ACT肽。根据我们治疗急性伤口的数据以及糖尿病C57BL/KsJ-m+/+Leptdb （db+/db+）小鼠伤口愈合的初步数据，我们相信我们的先导化合物ACT1肽对治疗慢性伤口（如DFU）有有益的作用。ACT1肽已被证明可以显著抑制最初的炎症反应，并通过伤口愈合促进更快有效的进展。我们假设ACT1肽将提供一种独特的、基于机械的方法来恢复糖尿病患者伤口愈合的正常进展。第一阶段项目的里程碑：探讨ACT1肽在糖尿病C57BL/KsJ-m+/+Leptdb （db+/db+）小鼠中是否促进创面愈合和减轻炎症。2. 通过血液分析和尸检，确定在糖尿病C57BL/KsJ-m+/+Leptdb （db+/db+）小鼠皮肤伤口局部应用ACT1肽是否有任何全身效应。

DESCRIPTION (provided by applicant): According to the American Diabetes Association, there are more than 16 million people in the United States with known diabetes. Diabetic patients commonly demonstrate impaired wound healing. Approximately 20 percent of patients with diabetes will develop foot ulceration in their lifetime. Diabetic foot ulceration (DFU) represents a major problem that can significantly impair the patient's quality of life, require prolonged hospitalization, and may involve infection, gangrene, and amputation. It has been estimated that for each new foot ulcer the attributable cost for a middle-aged diabetic man in the first two years is approximately $ 30,000. The cost of DFU to the healthcare system is over one billion dollars per year in the United States. A well- established reason as to why diabetic wounds are tough to heal is that they do not progress through the normal healing phases. Instead, it is thought that diabetic wounds are caught and remain trapped in the initial inflammatory phase of wound healing. FirstString Research, Inc. (FSR) is a biotech company located in Charleston, South Carolina. The founders of FSR, Drs. Robert Gourdie and Gautam Ghatnekar are co inventors of a class of novel bioengineered peptides - we refer to as ACT peptides. Based on our data from treatment of acute wounds as well as preliminary data from wound healing in diabetic C57BL/KsJ-m+/+Leptdb (db+/db+) mice, we believe that our lead compound, ACT1 peptide will have beneficial effects in the treatment of chronic wounds such as DFU's. ACT1 peptide has been shown to significantly dampen down the initial inflammatory response and promote faster and effective progression through wound healing. We hypothesize that ACT1 peptide will provide a unique, mechanistically based approach to restoring normal progression of wound healing in diabetics. Milestones for Phase I project: 1. To determine whether or not ACT1 peptide promotes wound healing, and reduces inflammation in diabetic C57BL/KsJ-m+/+Leptdb (db+/db+) mice. 2. To determine if topically applied ACT1 peptide on skin wounds in diabetic C57BL/KsJ-m+/+Leptdb (db+/db+) mice has any systemic effects as evaluated by blood analyses and necropsy. Present therapies and drugs for wound healing in diabetes and chronic wounds in general are predominantly symptomatic, empirical, unpredictable, and largely ineffective The ACT1 peptide potentially offers a mechanistically based solution to not just faster wound closure but also significant cost savings and more importantly improving the quality of life in diabetic patients. The development of FSR's ACT1 peptide via milestones outlined in this SBIR, not only will meet this specific need for patients and surgeons, but also has the potential to lay a platform for broader clinical applications and commercial opportunities.