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Developing Intravesical Liposomes for Interstitial Cystitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42DK085733-04
Agency Tracking Number: R42DK085733
Amount: $741,288.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIDDK
Solicitation Number: PA13-235
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): 2014-08-01
Award End Date (Contract End Date): 2016-07-31
Small Business Information
Pittsburgh, PA 15217-1919
United States
DUNS: 187190850
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (412) 901-0315
Business Contact
Phone: (412) 901-0315
Research Institution
3601 W 13 MILE RD
ROYAL OAK, MI 48073-6712
United States

 Domestic nonprofit research organization

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 andquot Developing Intravesical Liposomes for Interstitial Cystitisandquot The project proposes to evaluate the safety and efficacy of an experimental drug named LP 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 in IC BPS patients compared to a placebo dose IC BPS is a poorly understood condition with significant unmet medical needs LP 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 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

PUBLIC HEALTH RELEVANCE This research proposal is for the National Institutes of Health Small Business Technology Transfer STTR program The project is titled andquot Developing Intravesical Liposomes for Interstitial Cystitisandquot and will further the clinical development of a drg to treat interstitial cystitis bladder pain syndrome IC BPS Up to one million people in the United States of America suffer from IC BPS an incurable chronic disease of the bladder believed to be caused by defects in the epithelial cells lining the bladder lumen There is limited
medical therapy for IC BPS The development of safe and effective new treatment for IC BPS is a major unmet need for many Americans

* Information listed above is at the time of submission. *

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