Developing Intravesical Liposomes for Interstitial Cystitis

Information

• Research Project
• 8780209

• ApplicationId

  8780209

• Core Project Number

  R42DK085733

• Full Project Number

  2R42DK085733-04

• Serial Number

  085733

• FOA Number

  PA-13-235

• Sub Project Id

• Project Start Date

  9/21/2009 - 14 years ago

• Project End Date

  7/31/2016 - 7 years ago

• Program Officer Name

  KIRKALI, ZIYA

• Budget Start Date

  8/1/2014 - 9 years ago

• Budget End Date

  7/31/2015 - 8 years ago

• Fiscal Year

  2014

• Support Year

  04

• Suffix

• Award Notice Date

  8/7/2014 - 9 years ago

Organizations

• Lipella Pharmaceuticals, Inc.

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.

IC Name

• Activity

  R42

• Administering IC

  DK

• Application Type

  2

• Direct Cost Amount

• Indirect Cost Amount

• Total Cost

  368266

• Sub Project Total Cost

• ARRA Funded

  False

• CFDA Code

  847

• Ed Inst. Type

• Funding ICs

  NIDDK:368266\

• Funding Mechanism

  SBIR-STTR RPGs

• Study Section

  UGPP

• Study Section Name

  Urologic and Genitourinary Physiology and Pathology

• Organization Name

  LIPELLA PHARMACEUTICALS, INC.

• Organization Department

• Organization DUNS

  187190850

• Organization City

  PITTSBURGH

• Organization State

  PA

• Organization Country

  UNITED STATES

• Organization Zip Code

  152171919

• Organization District

  UNITED STATES