Developing Intravesical Liposomes for Interstitial Cystitis

开发治疗间质性膀胱炎的膀胱内脂质体

• 批准号: 8780209
• 负责人: JONATHAN H KAUFMAN
• 金额: $ 36.83万
• 依托单位: LIPELLA PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-21 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8780209
• 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

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.（Pittsburgh，PA）是一家临床阶段的制药公司，专门从事膀胱功能障碍的膀胱内治疗。Lipella正在向小企业技术转让计划提交一份研究提案，题为“开发膀胱内脂质体治疗间质性膀胱炎”。该项目拟在一项新的临床研究中评价一种名为LP- 08的试验药物治疗间质性膀胱炎/膀胱疼痛综合征（IC/BPS）的安全性和有效性。该提案分为两个具体目标，支持Lipella申办的IIB期随机临床试验的执行，以评估IC/BPS患者中两种不同剂量的LP-08与安慰剂剂量的比较。IC/BPS是一种知之甚少的疾病，具有显著的未满足的医疗需求。LP-08是通过导尿管直接递送至膀胱的脂质体制剂。脂质体是由磷脂双层组成的囊泡，由水隔室分隔。LP-08的预期主要作用是减轻IC/BPS在患者中引起的刺激和疼痛。该STTR的成功完成将为衰弱综合征的新疗法提供重要的临床数据，并大大改善将产品推向市场的前景。