Lipella Pharmaceuticals Inc., a company focused on the development of therapeutic agents for urinary bladder disorders, has presented in vivo efficacy data on non-clinical studies concerning its product LP-10, an intravesical drug candidate for radiation cystitis. The results were presented at the 2015 Annual Meeting of the American Urological Association (AUA) in New Orleans, May 15 – 19, and the poster presentation was entitled “Intravesical liposomal tacrolimus protects against radiation cystitis induced by 3-beam targeted bladder radiation”.

Radiation cystitis is a complication in the bladder resulting from radiation therapy to pelvic tumors. It corresponds to an inflammatory condition of the urinary bladder that is characterized by chronic radiation-induced bleeding. Pelvic radiation therapy is often employed as part of the treatment strategy in a variety of cancers that affect the pelvic area, namely cervical cancer, but also ovarian, prostate and colorectal cancers. Radiation cystitis can appear months or years after pelvic radiation therapy, and if not managed properly, it can lead to cystectomy (the surgical removal of the bladder) and to patient’s death. Currently, there are no approved drugs by the U.S. Food and Drug Administration (FDA) for radiation cystitis’ treatment.

Lipella’s LP-10 corresponds to a liposomal formulation of tacrolimus, a potent immunosuppressive drug that also has strong anti-inflammatory properties. LP-10 has received, in 2012, the Orphan Designation from the FDA for the treatment of hemorrhagic cystitis, heavy bladder bleeding due to chemo- or radiation cystitis.

Researchers showed in the AUA Meeting that in Sprague-Dawley rats exposed to targeted bladder radiation, intravesical administration of LP-10 was able to reverse the harmful effects of radiation. Saline controls were used for comparison. The team will publish the results in the August 2015 issue of the Journal of Urology, under the title “Intravesical liposomal tacrolimus protects against radiation cystitis induced by 3-beam targeted bladder radiation”.

“LP-10 has already demonstrated pre-clinical efficacy in chemo-cystitis,” said the Chief Executive Officer of Lipella Pharmaceuticals Inc., Dr. Jonathan H. Kaufman in the press release. “We are pleased to see its pre-clinical efficacy confirmed in radiation-cystitis as well, and look forward to completing IND [Investigational New Drug] enabling studies in the near future.”