New Treatment for Inflammation in Middle Ear Infections

描述（由申请人提供）：急性中耳炎（AOM）是一种常见的中耳炎症性疾病，以疼痛和听力丧失为特征。抗生素治疗感染，通常会导致症状缓解，但并不针对炎症参数，如中耳积液（MEE），这可能导致听力损失和其他并发症。没有直接针对中耳炎症的治疗方法。Targeted Gene Delivery, Inc.已经鉴定并鉴定了一种肽（肽P13），它干扰细胞内促炎信号和细胞活化，这是由病原体产物与免疫细胞相互作用引起的。在II期研究中产生的数据表明，在小鼠模型中，使用热灭活肺炎链球菌和流感嗜血杆菌同时注射肽治疗可显着减少中耳炎症。该II期竞争更新提案的目的是生成临床前疗效和毒性数据，以支持将肽P13用作AOM抗炎治疗的研究新药（IND）申请。我们将在临床相关模型中使用活菌和延迟肽治疗来检测肽P13的疗效。当这些研究完成后，我们将开始临床前毒性测试，以启动临床试验。这些研究有可能确定一种治疗中耳炎症的新方法，并将应用于其他感染导致有害炎症疾病的临床情况。急性中耳炎（AOM）通常以长期炎症为特征，导致听力丧失和其他并发症。抗生素治疗感染，但不针对炎症。我们已经确定了一种新的治疗肽，在AOM小鼠模型中显示出显著的抗炎作用。通过疗效和毒性试验，该肽将成为治疗AOM的新疗法

DESCRIPTION (provided by applicant): Acute otitis media (AOM) is a common inflammatory disease of the middle ear characterized by pain and hearing loss. Antibiotics treat infection and often result in symptomatic relief, but do not target inflammatory parameters such as middle ear effusion (MEE), which can cause hearing loss and other complications. No therapies directly target middle ear inflammation. Targeted Gene Delivery, Inc. has identified and characterized a peptide (peptide P13) that interferes with intracellular pro-inflammatory signaling and cell activation that results from the interaction of pathogen products with immune cells. Data generated during the Phase II study demonstrated a dramatic reduction in middle ear inflammation in a murine model using heat- inactivated S. pneumoniae and H. influenzae injected simultaneously with peptide treatment. The purpose of this Phase II Competing Renewal proposal will be to generate pre-clinical efficacy and toxicity data to support an Investigational New Drug (IND) application to use peptide P13 as an anti-inflammatory therapy in AOM. We will examine peptide P13 efficacy in a clinically relevant model using viable bacteria and delayed peptide treatment. When these studies are completed, we will begin the pre-clinical toxicity testing necessary to initiate clinical trials. These studies have the potential to define a new approach to treating middle ear inflammation and will have application for other clinical conditions in which infections lead to detrimental inflammatory disease. Acute otitis media (AOM) is often characterized by prolonged inflammation that causes hearing loss and other complications. Antibiotics treat infection, but do not target inflammation. We have identified a novel therapeutic peptide that has demonstrated significant anti-inflammatory effects in a murine model of AOM. Through efficacy and toxicity testing, this peptide will be developed as a new therapy for treatment of AOM