Presentation Focused on Positive Results from Recent Phase 2a Study
PITTSBURGH, May 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that it has delivered a late-breaking presentation at the annual meeting of the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.
The Phase 2a study data was presented by Dr. Jason Hafron, Principal Investigator for Lipella's national trial, and a urologist specializing in the minimally invasive treatment of cancers involving the prostate, kidney and bladder, utilizing robotic surgery.
Dr. Hafron commented, "The clinical trial was a multi-center, dose-escalation Phase 2a study of 13 subjects with moderate to severe refractory hemorrhagic cystitis. Subjects were treated with up to two courses of LP-10 intravesical bladder instillations, which were tolerated without report of product related serious adverse events.
"The treatment response was fast and patients were able to tolerate LP-10. The study demonstrated decreased hematuria, decreased cystoscopic bleeding and ulceration sites, and improved urinary symptoms in patients.
"These results are very encouraging. Having a safe and effective drug to treat hemorrhagic cystitis would be a major service to the field of urology."
Lipella Pharmaceuticals CEO, Dr. Jonathan Kaufman, added, "We are very pleased to have successfully completed our Phase 2a clinical trial. The study's positive results bring us closer to bringing a first-in-class hemorrhagic cystitis treatment to the cancer survivor community."
Lipella anticipates scheduling a Type B meeting with the FDA regarding this program in the next few months.
ABOUT HEMORRHAGIC CYSTITIS
Lipella received Orphan Disease Designation LP-10 for the treatment of moderate to severe hemorrhagic cystitis, a disease with great unmet need and no currently approved drug treatment. Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers can cause chronic, painful urinary inflammation and blood loss called radiation 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.
ABOUT LIPELLA PHARMACEUTICALS INC.
Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.
Forward-Looking Statements
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CONTACT
Chuck Harbey
PCG Advisory
charbey@pcgadvisory.com
646.863.6341
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SOURCE Lipella Pharmaceuticals Inc.
