16 October 2020 - - US-based clinical-stage pharmaceutical company Lipella Pharmaceuticals Inc has begun recruiting patients in the company's phase 2a clinical trial to study the dose-dependent, safety and efficacy of LP-10 (liposomal tacrolimus) for the treatment of hemorrhagic cystitis, the company said.

Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers can cause chronic, painful urinary inflammation and blood loss called hemorrhagic cystitis. Certain chemotherapies (such as cyclophosphamide) can also cause this painful form of urinary bleeding.

The blood loss, associated with hemorrhagic cystitis can lead to surgery, and can be fatal.

There are currently no adequate therapies available for the treatment of moderate to severe hemorrhagic cystitis patients.

LP-10 is a proprietary liposomal formulation of tacrolimus that is currently being evaluated as a treatment for moderate to severe hemorrhagic cystitis.

Lipella Pharmaceuticals received FDA Orphan Designation for the use of tacrolimus for the treatment of hemorrhagic cystitis.

Lipella Pharmaceuticals is a clinical stage pharmaceutical company with a focus on capital efficient therapeutic development opportunities, including the proprietary repositioning of generics for rare, morbid diseases that currently have no adequate treatments.