Hemorrhagic cystitis (HC) is an inflammatory illness marked by bleeding in the bladder and urinary pain. HC is a complication of radiation therapy and chemotherapy used to treat cancers of the pelvic area?prostate, ovarian, cervical, bladder, and colorectal. Because the bladder exhibits slow cell-turnover, HC can emerge months or years after such procedures and once HC occurs, it often continues to re-occur. HC can severely degrade a patient's quality of life, require long-term follow-up treatment, and is sometimes fatal. There are currently no FDA approved therapies to treat HC and most available treatment options are not considered effective. Invasive treatments options like bladder cystectomy are not tolerable for older patients with HC. The treatment of HC represent an unmet medical need. This Small Business Innovative Research project will complete the first clinical trial for a new product indicated for the treatment of HC. This proposed project is a critical step leading to a marketable product and the first potential treatment for HC.

Public Health Relevance

Hemorrhagic cystitis is a rare and serious urological condition that occurs in some patients that receive pelvic radiation and/or chemotherapy. The condition is characterized by lower urinary tract symptoms that include urinary pain and signifgiant hematuria (unary bleeding). Hemorragic cystitis is sometimes fatal without appropriate treatment, yet existing treatment options for hemorrhagic cystitis are neither effective nor approved by the FDA. The treatment of hemorrhagic cystitis represent an unmet medical need. This Small Businness Innovative Research project will complete the first clinical trial for a new drug indicated for the treatment of hemorrhagic cystitis. Given the lack of good treatment options for patients with this condition, a successful project has the strong potential to advance public health.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Project #
2SB1DK102247-04A1
Application #
9345180
Study Section
Special Emphasis Panel (ZRG1-ETTN-C (56)R)
Program Officer
Gossett, Daniel Robert
Project Start
2014-05-12
Project End
2019-04-30
Budget Start
2017-05-05
Budget End
2018-04-30
Support Year
4
Fiscal Year
2017
Total Cost
$514,245
Indirect Cost
$70,246
Name
Lipella Pharmaceuticals, Inc.
Department
Type
Domestic for-Profits
DUNS #
187190850
City
Pittsburgh
State
PA
Country
United States
Zip Code
15217
Rajaganapathy, Bharathi Raja; Janicki, Joseph J; Levanovich, Peter et al. (2015) Intravesical Liposomal Tacrolimus Protects against Radiation Cystitis Induced by 3-Beam Targeted Bladder Radiation. J Urol 194:578-84