Therapeutic to Reduce Acute Inflammation in Severe Burn Injuries

描述（由申请人提供）：Declmmune Therapeutics正在寻求支持，以开发一种治疗产品，该产品将显著减少严重烧伤导致的衰弱和有时危及生命的结果。烧伤后组织损失的最终程度很大程度上取决于炎症反应。该公司开发了新的方法和化合物，可以抑制组织损伤初始部位的炎症，并显著减少损伤周围组织的破坏。烧伤动物模型的初步研究表明，这些化合物中的一种具有潜在的保护作用，可以防止烧伤后皮肤组织的炎症破坏，从而在不留下疤痕或毛发生长丧失的情况下愈合。每年有超过75 000名患者因严重烧伤住院，平均花费两周时间接受痛苦和昂贵的治疗，包括抗生素、营养品和伤口手术护理。该项目的长期目标是开发一种治疗产品，减少烧伤后皮肤组织的炎症破坏，改善严重烧伤患者的预后。这种治疗方法可能导致伤口愈合更快，不需要植皮或其他手术干预，降低住院费用，减少对患者的永久性疤痕和衰弱影响。Declmmune在动物模型中开发了阻断缺血/再灌注损伤后急性炎症的化合物。本提案的目的是在小鼠热烧伤模型中测试这些化合物，目的如下：1)证明一种或多种化合物对改善急性烧伤的愈合有效，2)确定烧伤后多长时间该化合物可以被施用并有效，3)确定烧伤伤口的严重程度仍可以使用该化合物进行改善。预期的终点是证明在我们的动物模型中，一种或多种化合物可以在烧伤后立即或短期内静脉注射或局部注射，烧伤伤口愈合，与未治疗的动物相比，瘢痕和毛发脱落明显减少。二期SBIR资金将支持多肽化合物开发为候选药物，临床前测试和一期人体试验的临床评估。

DESCRIPTION (provided by applicant): Declmmune Therapeutics is seeking support to develop a therapeutic product that will significantly reduce the debilitating and sometimes life-threatening result of severe burn injuries. Much of the final extent of tissue loss following burn injury is determined by the inflammatory response. The company has developed novel methods and compounds that inhibit inflammation at the initial site of tissue injury and significantly reduce the destruction of tissue surrounding the injury. Preliminary studies in animal models of burn injury have demonstrated a potential protective effect of one of these compounds, preventing the inflammatory destruction of skin tissue following burn trauma, resulting in healing without scarring or loss of hair growth. Over 75,000 patients per year are hospitalized for severe burn injuries, spending an average of two weeks undergoing painful and expensive treatments consisting of antibiotics, nutritionals and surgical care of the wound. The long-term objective of this project is to develop a therapeutic product that reduces the inflammatory destruction of skin tissue following burn injury and improves the outcome of the severely burned patient. Such a therapeutic could result in a wound which heals faster and with less need for skin grafting or other surgical intervention, reduce hospitalization costs and result in less permanent scarring and debilitating effects to the patient. Declmmune has developed compounds which block acute inflammation following ischemia/reperfusion injury in animal models. The objective of this proposal is to test these compounds in a mouse model of thermal burn injury with the following aims: 1) To demonstrate that one or more of these compounds is effective in improving the healing of an acute burn, 2) To determine how long after the burn injury the compound can be administered and be effective, and 3) To determine how severe a burn wound can still show improvement with the compound. The expected endpoint is the demonstration that in our animal model, one or more of these compounds can be administered immediately or shortly after a burn injury, either intravenously or topically, and the burn wound is shown to heal with significantly less scarring and loss of hair growth vs. the untreated animal. Phase II SBIR funding will support the development of the peptide compound into a drug candidate, preclinical testing and clinical evaluation in Phase I human trials.