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性疾病，以疼痛和听力丧失为特征。抗生素治疗感染，往往导致症状缓解，但不针对炎症参数，如中耳积液（中耳积液），这可能会导致听力损失和其他并发症。没有直接针对中耳炎的治疗方法。靶向基因递送公司已经鉴定并表征了一种肽（肽P13），其干扰由病原体产物与免疫细胞相互作用引起的细胞内促炎信号传导和细胞活化。在II期研究期间产生的数据表明，使用热灭活的S. pneumoniae和H.流感病毒与肽治疗同时注射。本II期竞争性更新提案的目的是生成临床前疗效和毒性数据，以支持使用肽P13作为AOM抗炎治疗的研究性新药（IND）申请。我们将使用活细菌和延迟肽治疗在临床相关模型中检查肽P13的功效。这些研究完成后，我们将开始启动临床试验所需的临床前毒性试验。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性疾病的临床条件。急性中耳炎（AOM）通常以导致听力损失和其他并发症的长期炎症为特征。抗生素治疗感染，但不针对炎症。我们已经鉴定了一种新的治疗肽，其在AOM小鼠模型中表现出显著的抗炎作用。通过疗效和毒性试验，该肽有望成为治疗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