Clinical Development of Tacrolimus for Hemorrhagic Cystitis

ABSTRACT Hemorrhagic cystitisHCis an inflammatory illness marked by bleeding in the bladder and urinary painHC is a complication of radiation therapy and chemotherapy used to treat cancers of the pelvic area prostateovariancervicalbladderand colorectalBecause the bladder exhibits slow cell turnoverHC can emerge months or years after such procedures and once HC occursit often continues to re occurHC can severely degrade a patient s quality of liferequire long term follow up treatmentand is sometimes fatalThere are currently no FDA approved therapies to treat HC and most available treatment options are not considered effectiveInvasive treatments options like bladder cystectomy are not tolerable for older patients with HCThe treatment of HC represent an unmet medical needThis Small Business Innovative Research project will complete the first clinical trial for a new product indicated for the treatment of HCThis proposed project is a critical step leading to a marketable product and the first potential treatment for HC