USA flag logo/image

An Official Website of the United States Government

Intravesical Liposome Treatment for Interstitial Cystitis

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
81126
Program Year/Program:
2008 / SBIR
Agency Tracking Number:
DK074286
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
LIPELLA PHARMACEUTICALS, INC.
5414 GUARINO RD PITTSBURGH, PA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2008
Title: Intravesical Liposome Treatment for Interstitial Cystitis
Agency: HHS
Contract: 2R44DK074286-02A1
Award Amount: $750,000.00
 

Abstract:

DESCRIPTION (provided by applicant): Interstitial cystitis (IC) is a chronic, severely debilitating disease of the urinary bladder. It can be described as a chronic inflammatory condition of the bladder wall, characterized by urinary frequency and urgency, and severe suprapubic and/or pelvic pain. Presently, there is limited medical therapy for IC and new and effective treatment is a major unmet medical need. Lipella Pharmaceuticals Inc. intends to be the leading company specializing in the use of intravesi cal liposome technology to treat IC. We have developed a method of formulating highly specific liposomes for intravesical instillation. The technology is licensed from inventions and research by Drs. Leaf Huang and Michael Chancellor at the University of P ittsburgh. Based on their research that a liposome itself can provides a soothing effect to an irritated bladder (RO1 DK068556; Fraser et al. 2003), Lipella Pharmaceuticals expects that intravesical liposome formulations can present an improved activity in patients with IC. Prior to submitting this phase-II proposal, phase-I funding was used primarily to explore preclinical safety considerations of LP-08, a novel intravesical liposome therapy for IC, in a rat model. This phase-II proposal includes further s afety studies, specifically measuring consequences of expected repeat dosing, as well as developing manufacturing scale-up procedures necessary for subsequent human testing. The effort proposed here would, in part, contribute to pre-clinical data collectio n prior to filing an FDA Investigational New Drug (IND) application, a regulatory requirement prior to administering LPA-08 in humans. PUBLIC HEALTH RELEVANCE We propose key preclinical experiments in an animal model to validate follow-on inves tment for clinical development of a novel treatment for painful bladder syndrome, an incurable chronic illness involving pain, urinary urgency, loss of sleep, depression and anxiety in approximately 500,000 women domestically.

Principal Investigator:

Business Contact:


jhk@lipella.com
Small Business Information at Submission:

LIPELLA PHARMACEUTICALS, INC.
LIPELLA PHARMACEUTICALS, INC. 5414 GUARINO RD PITTSBURGH, PA 15217

EIN/Tax ID: 202388040
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No