Optimum Dose of rhCC10 for Lung Protection in IRDS

描述（从申请人描述中扫描）：拟定研究 涉及评价重组人CC 10的剂量反应， 早产羔羊，新生儿/婴儿呼吸系统的表面活性剂依赖性模型 窘迫综合征（IRDS）。临床应用早产羔羊模型， 用于治疗IRDS的人造表面活性剂的开发。CC 10是 通常由气管和支气管上皮细胞的Clara细胞分泌， 成熟的肺它在肺的细胞外液中含量丰富， 内源性表面活性剂的天然成分。类似于表面活性剂，CC 10是 早产儿的肺里没有初步结果表明 事实上，CC 10对正常的肺功能至关重要， rhCC 10策略可能有效减少肺部炎症， 早产儿慢性肺病（CLD）的发病率 呼吸窘迫高剂量rhCC 10给药的安全性 已经在新生仔猪的临床前研究中确立。一 对照研究，以优化最大肺保护的剂量反应， 定义临床参数以测量rhCC 10的疗效， 在早产儿表面活性剂依赖性模型中与人工表面活性剂联合使用 目前，IRDS已被提出。 拟定商业应用： CC 10目前处于rhCC 10预防新生儿支气管肺发育不良的临床开发I期。 这项研究对于设计有效的给药策略具有重要意义 用于进一步的临床开发。 根据最近的估计， 美国每年都有早产儿出生。 其中约5万人将有婴儿 呼吸窘迫综合征（IRDS），其中20，000名患有IRDS的婴儿将发展为 BPD或某种形式的慢性肺病。 每年治疗这些婴儿的费用 出生后的头三个月每人大约20万美元，每年的最低费用为 40亿美元 这些婴儿中的许多人在整个童年时期都有呼吸问题 而持续护理的费用，并没有包括在每年40亿元的预算内。 重组人CC 10有可能预防这种疾病，并减少每年的发病率。 照顾这些孩子的经济负担。 RhCC 10也可能在治疗 许多儿童和成人呼吸道疾病也是如此。

DESCRIPTION (Scanned from the applicant's description): The proposed study involves an evaluation of the dose response to recombinant human CC10 in the preterm lamb, a surfactant-dependent model of neonatal/infant respiratory distress syndrome (IRDS). The preterm lamb model was used in the clinical development of artificial surfactants for the treatment of IRDS. CC10 is normally secreted by the Clara cells of the tracheal and bronchial epithelia of the mature lung. It is abundant in the extracellular fluids of the lungs and is a natural component of endogenous surfactant. Analogous to surfactant, CC10 is not present in the lungs of preterm babies. Preliminary results indicate that CC10 is, in fact, essential to normal lung function, and that a replacement strategy with rhCC10 may be effective in reducing pulmonary inflammation and incidence of chronic lung disease (CLD) in premature babies treated for respiratory distress. The safety of administration of high doses of rhCC10 has already been established in pre-clinical studies in newborn piglets. A controlled study to optimize the dose response for maximal lung protection and define the clinical parameters to measure efficacy of rhCC10, administered in conjunction with artificial surfactant, in a preterm surfactant dependent model of IRDS, is now proposed. PROPOSED COMMERCIAL APPLICATION: CC10 is currently in Phase I of clinical development of rhCC10 for the prevention of neonatal broncho-pulmonary dysplasia. This study is important in designing effective dosing strategies for further clinical development. According to recent estimates, approximately 90,000 premature babies are born in the U.S. each year. Of those, about 50,000 will have infant respiratory distress syndrome (IRDS) AND 20,000 of those babies with IRDs will develop BPD or some form of chronic lung disease. The annual cost of treating these babies in the first three months of life is about $200,000 each for an annual expense of a minimum of $4 billion. Many of these babies continue to have respiratory problems throughout childhood and the cost of this continued care have not been included in the $4 billion/year estimate. Recombinant human CC10 has the potential to prevent this disease and reduce the annual economic burden of caring for these children. RhCC10 may also be important in treating many pediatric and adult respiratory diseases as well.