Bladder drug delivery using intravesical liposomes to treat overactive bladder

描述（由申请人提供）：Lipella Pharmaceutical Inc已成功开发了用于治疗膀胱疼痛综合征/间质性膀胱炎（PBS/IC）的膀胱内脂质体。 通过SBIR的资助，Lipella成功地建立了其主要脂质体制剂LPA-08的临床前安全性。LPA-08是在匹兹堡大学发现的，并独家授权给Lipella。LPA-08的知识产权通过提交两项完整的专利申请得到保护。第一项专利已经由美国专利商标局发布，标题为“脂质载体的应用和药物递送的用途”，专利号为7，063，860，于2006年6月20日授予。这是全新的SBIR-I提交。Lipella将探索使用膀胱内脂质体作为先进的膀胱内给药平台的管道潜力。Michael Chancellor博士最近从匹兹堡大学受聘成为密歇根州皇家橡树William博蒙医院泌尿科神经泌尿学项目主任。Chancellor博士也是Lipella科学顾问委员会（SAB）的主席。在本SBIR-I中，我们将评估膀胱内脂质体作为膀胱内药物递送平台的第二大优势。这对Lipella来说是一个新的课题，对于Lipella成为一家拥有产品开发管道的成功生物技术公司至关重要。在这项为期六个月的试点SBIR-I研究中，我们将评估使用肉毒杆菌毒素-A（脂质体-BoNT）的液体脂质体递送到膀胱中而不需要膀胱镜引导的针注射用于难治性膀胱过度活动症（OAB）的概念证明。如果成功，我们将利用商业投资和SBIR-II进一步扩大脂质体-BoNT用于难治性OAB建模，递送用于OAB和PBS/IC的其他药物，用于尿路感染的抗生素以及用于治疗局部膀胱癌的化疗剂和/或免疫调节剂的脂质体。 公共卫生相关性：通过之前的SBIR-I资助，Lipella Pharmaceutical Inc已成功建立其主要脂质体制剂LPA-08的临床前安全性。在这个全新的SBIR-I提交。Lipella将探索使用膀胱内脂质体作为先进的膀胱内药物递送平台的管道潜力。在这项为期六个月的试点SBIR-I研究中，我们将评估使用肉毒杆菌毒素-A（脂质体-BoNT）的液体脂质体递送到膀胱中而不需要膀胱镜引导的针注射用于难治性膀胱过度活动症（OAB）的概念证明。

DESCRIPTION (provided by applicant): Lipella Pharmaceutical Inc has been successful with development of intravesical liposome for painful bladder syndrome/Interstitial cystitis (PBS/IC). Through SBIR funding, Lipella has been successful in establishing the pre-clinical safety of its primary liposome formulation LPA-08. LPA-08 was discovered at the University of Pittsburgh and exclusively licensed to Lipella. IP of LPA-08 is protected through the filing of two full patent applications. A first patent has already been issued by the USPTO titled Application of Lipid Vehicles and Use for Drug Delivery, patent number 7,063,860, awarded June 20, 2006. This is totally new SBIR-I submission. Lipella will explore the pipeline potential of using intravesical liposome as an advanced intravesical drug delivery platform. Dr. Michael Chancellor was recently recruited from the University of Pittsburgh to become Director of Neurourology Program in the Department of Urology at William Beaumont Hospital in Royal Oak, MI. Dr. Chancellor is also Chairperson of the Scientific Advisory Board (SAB) at Lipella. In this SBIR-I, we will evaluate the 2nd major strength of intravesical liposome as a platform for intravesical drug delivery. This is a new topic for Lipella and is critical for Lipella to be a successful biotechnology company with a product development pipeline. In this six month pilot SBIR-I study, we will evaluate proof of concept of using liquid liposome delivery of botulinum toxin-A (Liposome-BoNT) into the bladder without need for cystscopic guided needle injection for refractory overactive bladder (OAB). If successful, we will leverage commercial investment and SBIR-II on further expanding liposome-BoNT for refractory OAB modeling, delivery of other drugs for OAB and PBS/IC, antibiotics for urinary tract infections and also liposome of chemotherapeutic, and/or immunomodulatory agents for treatment of localized bladder cancer. PUBLIC HEALTH RELEVANCE: Through previous SBIR-I funding, Lipella Pharmaceutical Inc has been successful in establishing the pre-clinical safety of its primary liposome formulation LPA-08. In this completely new SBIR-I submission. Lipella will explore the pipeline potential of using in- travesical liposome as an advanced intravesical drug delivery platform. In this six month pilot SBIR-I study, we will evaluate proof of concept of using liquid liposome delivery of botulinum toxin-A (Liposome-BoNT) into the bladder without need for cystscopic guided needle injection for refractory overactive bladder (OAB).