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 the U.S. Food and Drug Administration (“FDA”) has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for the evaluation of LP-10, an intravesical liposomal formulation of tacrolimus, as a potential treatment for moderate to severe hemorrhagic cystitis (HC). Lipella expects to meet with the FDA on May 21, 2024.
HC is a serious, life-threatening form of gross hematuria (i.e. visible blood in urine) caused by cancer treatments including pelvic radiation therapy, and certain chemotherapies including cyclophosphamide and ifosfamide, which are most commonly used for the treatment of breast cancer.
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