Clinical Development of Tacrolimus for Hemorrhagic Cystitis

Information

  • Research Project
  • 9480845
  • ApplicationId
    9480845
  • Core Project Number
    SB1DK102247
  • Full Project Number
    5SB1DK102247-05
  • Serial Number
    102247
  • FOA Number
    PAR-16-027
  • Sub Project Id
  • Project Start Date
    5/12/2014 - 10 years ago
  • Project End Date
    4/30/2019 - 5 years ago
  • Program Officer Name
    GOSSETT, DANIEL ROBERT
  • Budget Start Date
    5/1/2018 - 6 years ago
  • Budget End Date
    4/30/2019 - 5 years ago
  • Fiscal Year
    2018
  • Support Year
    05
  • Suffix
  • Award Notice Date
    5/4/2018 - 6 years ago

Clinical Development of Tacrolimus for Hemorrhagic Cystitis

ABSTRACT 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.

IC Name
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
  • Activity
    SB1
  • Administering IC
    DK
  • Application Type
    5
  • Direct Cost Amount
    417461
  • Indirect Cost Amount
    66760
  • Total Cost
    484221
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    847
  • Ed Inst. Type
  • Funding ICs
    NIDDK:484221\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • 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