Pneumoreductive Surfactant Therapy for Emphysema

描述(由申请人提供)：Aeris Treateutics正在为晚期肺气肿患者开发一种新的医疗方法，称为气动减缩表面活性物质(PRS)。PRSS是通过安全地改变天然肺表面活性物质的表面张力属性来增加肺反冲的吸入性药物。与现有的治疗慢性阻塞性肺病的药物不同，PRS是唯一一种专门针对肺气肿的治疗而设计的药物，它通过改善肺反冲和减少恶性通货膨胀。在第一阶段SBIR资助期间(2004年9月至2005年3月)，Aeris确定了两种在体外有利于改变肺表面活性物质功能并在体内肺气肿模型中有效增加肺反冲的PRS配方。这些制剂中最好的已经被挑选出来用于产品开发。剂量-反应和剂量传递研究表明，使用传统的雾化系统，PRSS可以有效地传递到肺部。重复给药研究证实了PRS给药的安全性，最长可达两周。已经确定了制造PR的原料的GMP来源，并制定了制造方案、临床计划和监管战略，以推动该产品进入临床试验。Aeris正在请求第二阶段SBIR支持，以推动这一令人兴奋的新治疗产品的开发。

DESCRIPTION (provided by applicant): Aeris therapeutics is developing a novel medical treatment for patients with advanced emphysema known as Pneumoreductive Surfactant (PRS). PRSs are inhaled drugs that increase lung recoil by safely altering the surface tension properties of native lung surfactant. Unlike existing medical therapies for chronic obstructive pulmonary disease, PRS is the only medical therapy designed specifically to treat emphysema by improving lung recoil and decreasing hyperinflation. During Phase I SBIR funding (9/2004 to 3/2005), Aeris identified two PRS formulations that favorably alter lung surfactant function in vitro, and effectively increase lung recoil in emphysema models in vivo. The best of these preparations has been selected for product development. Dose-response and dose delivery studies demonstrate that PRSs can be effectively delivered to the lung using conventional nebulizer systems. Repeat dosing studies confirm the safety of PRS administration, out to two weeks. GMP sources of raw materials for manufacturing PRS have been identified, and a manufacturing protocol, clinical plan, and regulatory strategy have been developed for advancing this product into clinical testing. Aeris is requesting Phase II SBIR support to advance the development of this exciting new therapeutic product.