Preclinical Development of Tacrolimus for Radiation Cystitis

Information

  • Research Project
  • 8888531
  • ApplicationId
    8888531
  • Core Project Number
    R44DK102247
  • Full Project Number
    4R44DK102247-02
  • Serial Number
    102247
  • FOA Number
    PA-13-234
  • Sub Project Id
  • Project Start Date
    5/12/2014 - 10 years ago
  • Project End Date
    4/30/2017 - 7 years ago
  • Program Officer Name
    GOSSETT, DANIEL ROBERT
  • Budget Start Date
    5/1/2015 - 9 years ago
  • Budget End Date
    4/30/2016 - 8 years ago
  • Fiscal Year
    2015
  • Support Year
    02
  • Suffix
  • Award Notice Date
    5/19/2015 - 9 years ago

Preclinical Development of Tacrolimus for Radiation Cystitis

DESCRIPTION (provided by applicant): This project, entitied Preclinical Development of Tracrolimus for Radiation Cystitis will fund key experiments to advance the commercial development of LP-10. LP-10 is a liposomal tacrolimus formulation for local (topical) intravesical administration to the urinary bladder. The formulation provides active drug levels in the bladder with significantly reduced systemic levels. Radiation cystitis is a rare disease defined by lower urinary tract symptoms that include dysuria, hematuria, and hemorrhage. There are currently no approved therapies to treat RC, which can severely degrade a patient's quality of life, require long-term follow-up treatment, and, in some patients, lead to death. This project is public-private collaboration between Lipella Pharmaceuticals Inc., the University of Pittsburgh School of Medicine, and William Beaumont Hospital. Lipella owns intellectual property rights to the LP-10 formulation as well as rights associated with its recent receipt of orphan designation from the FDA. The FDA has also provided Lipella with pre-clinical requirements for IND consideration of LP-10. These requirements constitute the studies described in this proposal. The scope of work includes further pharmaceutical and pharmacological characterization of LP-10 (Phase I) and IND-enabling studies (Phase II). This research is translational, and bridges basic research to clinical development. Progress in this direction will directly support our ultimate goal of developing a safe and effective therapy ready for commercialization.

IC Name
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
  • Activity
    R44
  • Administering IC
    DK
  • Application Type
    4
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    648461
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    847
  • Ed Inst. Type
  • Funding ICs
    NIDDK:648461\
  • 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