Lipella Pharmaceuticals Initiates Its Phase-2a Clinical Trial of LP-10 for Hemorrhagic Cystitis

A multi-site, prospective, open-label, dose-escalation clinical trial assessing the safety and efficacy of LP-10 (liposomal tacrolimus) is now open for recruitment at several sites

PITTSBURGH–(BUSINESS WIRE)–Lipella Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on improving cancer survivorship, today announced it 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.

“We are encouraged to be able to provide LP-10 to qualified patients,” commented Jonathan Kaufman, Lipella’s Chief Executive Officer. “Two clinical sites have started patient screening and recruitment, and we look forward to opening additional sites in the near future.”

About Hemorrhagic Cystitis

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.

About LP-10

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.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals Inc. 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. Additional information is available at http://www.lipella. (Read more…)com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause Lipella’ results and the timing of certain events to differ materially from those discussed in the forward-looking statements, including risks associated with clinical development, regulatory approvals, product commercialization, intellectual property claims and litigation and other risks. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors.

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.

Key words: hemorrhagic cystitis; radiation cystitis; phase-2a clinical trial; cancer survivorship; 505(b)(2) regulatory pathway; urinary bleeding; painful bladder; liposomal; drug; therapeutic; pharmaceutical

Contacts

Allison Houck

Lipella Pharmaceuticals Inc.

412-894-1853

[email protected]