Clinical Development of Tacrolimus for Hemorrhagic Cystitis

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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.