Developing Intravesical Liposomes for Interstitial Cystitis

开发治疗间质性膀胱炎的膀胱内脂质体

基本信息

批准号：
8907997
负责人：
JONATHAN H KAUFMAN
金额：
$ 37.3万
依托单位：
LIPELLA PHARMACEUTICALS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-21 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8907997
关键词：
Adverse event Affect American Americas Bladder Bladder Dysfunction Businesses Caring Catheters Cell Line Chronic Chronic Disease Clinical Clinical Data Clinical Research Clinical Trials Defect Development Disease Dose Double-Blind Method Drug Formulations Epithelial Cells Female Funding Goals Grant Hospitals Increased frequency of micturition Inflammatory Interstitial Cystitis Liposomes Marketing Medical Methodology Names Pain Patients Pelvic Pain Pharmaceutical Preparations Pharmacologic Substance Phase Phospholipids Placebo Control Placebos Powder dose form Randomized Randomized Clinical Trials Research Research Design Research Proposals Safety Site Small Business Technology Transfer Research Staging Symptoms Syndrome System Technology Transfer Testing United States United States Food and Drug Administration United States National Institutes of Health Vesicle aqueous design effective therapy experience human subject improved intravesical irritation male micturition urgency novel pre-clinical programs public health relevance research clinical testing urinary urologic

项目摘要

DESCRIPTION (provided by applicant): Lipella Pharmaceuticals Inc. (Pittsburgh, PA) is a clinical-stage pharmaceutical company specializing in intravesical therapies for urinary bladder dysfunctions. Lipella is submitting a research proposal to the Small Business Technology Transfer program titled "Developing Intravesical Liposomes for Interstitial Cystitis". The project proposes to evaluate the safety and efficacy of an experimental drug, named LP- 08, for the indication of interstitial cystitis/ bladder pain syndrome (IC/BPS) in a new clinical study. The proposal is divided into two specific aims that support the execution of a Lipella-sponsored Phase IIB randomized clinical trial to evaluate two different doses of LP-08 in IC/BPS patients compared to a placebo dose. IC/BPS is a poorly understood condition with significant unmet medical needs. LP-08 is a liposome formulation delivered directly to the bladder via urinary catheter. Liposomes are vesicles composed of phospholipid bilayers separated by aqueous compartments. The intended primary effect of LP-08 is to alleviate irritation and pain caused by IC/BPS in patients. Successful completion of this STTR would provide significant clinical data on a novel therapy for a debilitating syndrome and greatly improve the prospect of bringing the product to market.

描述（由申请人提供）：Lipella Pharmaceuticals Inc.（宾夕法尼亚州匹兹堡）是一家临床阶段的制药公司，专门针对膀胱膀胱功能障碍进行静脉内疗法。 Lipella正在向小型企业技术转移计划提交了一项研究建议，标题为“开发用于间质膀胱炎的静脉内脂质体”。该项目建议在一项新的临床研究中评估名为LP-08的实验药物的安全性和功效，称为LP-08。该提案分为两个特定的目标，这些目标支持由Lipella赞助的IIB期随机临床试验执行，以评估IC/BPS患者的两种不同剂量的LP-08与安慰剂剂量相比。 IC/BPS是一种鲜为人知的疾病，没有明显的医疗需求。 LP-08是一种通过尿管直接传递到膀胱的脂质体配方。脂质体是由磷脂双层组成的囊泡。 LP-08的预期主要作用是减轻患者IC/BPS引起的刺激和疼痛。该STTR的成功完成将提供有关一种衰弱综合症的新疗法的重要临床数据，并大大改善了将产品推向市场的前景。