Lipella Pharmaceuticals Receives National Institutes of Health Funding for Its Orphan Drug Program

PITTSBURGH--(BUSINESS WIRE)--Lipella Pharmaceuticals Inc., today announced the award of a grant by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to support the pre-clinical development of LP-10, a topical-formulation of liposomal tacrolimus for the treatment of hemorrhagic cystitis.

“If LP-10 proves successful in the clinic, that could have a significant improvement in the lives of those with complications resulting from pelvic radiation therapy, which is often employed for the treatment of prostate cancer”

Hemorrhagic cystitis is a rare and serious complication of either pelvic radiation therapy or certain types of chemotherapies commonly used for treating pelvic area cancers. Hemorrhagic cystitis causes significant urinary bleeding that can ultimately result in cystectomy (surgical removal of the urinary bladder) if not adequately managed. There are currently no approved drugs for hemorrhagic cystitis, and existing management strategies (such as hyperbaric therapy) are extremely costly with limited availability.

To date, pre-clinical studies using LP-10 have demonstrated in-vivo efficacy in an animal model. Tacrolimus (the active ingredient in LP-10) is a powerful immunosuppressant primarily indicated for suppressing transplant rejection. Lipella recently received orphan designation from the FDA for the use of tacrolimus for hemorrhagic cystitis. “If LP-10 proves successful in the clinic, that could have a significant improvement in the lives of those with complications resulting from pelvic radiation therapy, which is often employed for the treatment of prostate cancer,” according to George Harriston, President of the Radiation Cystitis Foundation.

“This funding provides financial support for our remaining requirements to obtain investigational new drug approval from the FDA, which is the primary regulatory requirement for starting clinical trials,” stated Jonathan Kaufman, Chief Executive Officer of Lipella.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals Inc. is a specialty biopharmaceutical company focused on the development and commercialization of novel liposome formulations for multiple therapeutic applications. Lipella’s research and development assets include experimental and clinical stage products for interstitial cystitis, overactive bladder, and hemorrhagic cystitis. Lipella is a privately held company based in Pittsburgh, PA. For further company details, visit www.lipella.com.

Caution

LP-10 is currently not approved for commercial use in any indication in the United States and is limited by U.S. Federal Law to investigational use only.

The project described is supported by Award Number R44DK102247 from the NIDDK. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIDDK or the National Institutes of Health.