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

一种新型连接蛋白肽治疗糖尿病伤口的评价

• 批准号: 7405169
• 负责人: Gautam Sudhir Ghatnekar
• 金额: $ 14.12万
• 依托单位: XEQUEL BIO, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2008-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7405169
• 关键词: Acute; American; Amputation; Autopsy; Biomedical Engineering; Blood; Chronic; Cicatrix; Class; Clinical Trials; Closure; Complex; Connexins; Cost Savings; Data; Dental; Development; Diabetes Mellitus; Diabetic Foot; Diabetic wound; Dose; Evaluation; Event; Family suidae; Foot Ulcer; Future; Gangrene; Healed; Healthcare Systems; Heart Diseases; Hospitalization; Impaired wound healing; Infection; Inflammation; Inflammatory; Inflammatory Response; Injury; Investigational Drugs; Laboratories; Lead; Maps; Market Research; Mechanics; Methods; Modeling; Mus; Names; Natural regeneration; New Drug Approvals; Normal tissue morphology; Numbers; Patients; Peptides; Pharmacotherapy; Phase; Polychloroterphenyl Compounds; Prevention, Clinical, and Therapeutic Subcommittee; Process; Production; Publishing; Quality of life; Range; Regulation; Research; Safety; Site; Skin; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solutions; South Carolina; Surgeon; Sus scrofa; Therapeutic; Thinking; Time; Tissues; Topical application; Treatment Protocols; Ulcer; United States; Walking; Wound Healing; base; clinical application; cost; db/db mouse; diabetic; foot; healing; improved; man; middle age; novel; repaired; tissue regeneration; wound

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.

描述（由申请人提供）：根据美国糖尿病协会，美国有超过1600万人患有已知糖尿病。糖尿病患者通常表现出伤口愈合受损。大约20％的糖尿病患者会在其一生中出现足部溃疡。糖尿病足溃疡（DFU）代表了一个主要问题，可能会大大损害患者的生活质量，需要长时间住院，并且可能涉及感染，坏疽和截肢。据估计，对于每个新的脚溃疡，在头两年中，中年糖尿病患者的归因成本约为30,000美元。在美国，DFU对医疗保健系统的成本为每年超过10亿美元。关于为什么糖尿病伤很难治愈的一个很好的理由是，它们不会在正常的愈合阶段进展。取而代之的是，人们认为糖尿病伤被捕获并被困在伤口愈合的最初炎症阶段。 Firststring Research，Inc。（FSR）是位于南卡罗来纳州查尔斯顿的一家生物技术公司。 FSR的创始人，博士。 Robert Gourdie和Gautam Ghatnekar是一类新型生物工程肽的CO发明者 - 我们称为ACT肽。基于我们的急性伤口治疗以及糖尿病C57BL/KSJ-M+/+LeptDB（DB+/DB+）小鼠的伤口愈合的初步数据，我们相信我们的铅化合物，ACT1肽将在诸如DFU之类的慢性伤口治疗中具有有益的作用。 ACT1肽已被证明会显着抑制初始炎症反应，并通过伤口愈合促进更快，更有效的进展。我们假设ACT1肽将为恢复糖尿病患者伤口愈合的正常进展提供一种独特的基于机械的方法。 I期项目的里程碑：1。确定ACT1肽是否促进伤口愈合，并减少糖尿病C57BL/KSJ-M+/+LEPTDB（DB+/DB+）小鼠的炎症。 2。确定在糖尿病C57BL/KSJ-M+/+LeptDB（DB+/DB+）小鼠中局部应用ACT1肽在皮肤伤口上是否具有任何全身性作用，如血液分析和尸检所评估。 当前的糖尿病和慢性伤口伤口愈合的疗法和药物通常是症状，经验性，不可预测的，并且在很大程度上无效，ACT1肽潜在地提供了基于机械的解决方案，不仅提供了更快的伤口封闭，而且更重要的成本节省，并且更重要的是糖尿病患者的质量。通过此SBIR概述的里程碑开发FSR的ACT1肽，不仅可以满足患者和外科医生的这一特定需求，而且有可能为更广泛的临床应用和商业机会建立平台。