Lipella Pharmaceuticals Received FDA IND Approval for Phase-2a Oncology Supportive Care Drug Study

On March 26, 2019 Lipella Pharmaceuticals Inc., a clinical stage biopharmaceutical company based in Pittsburgh, PA, reported the investigational new drug (IND) approval for a phase-2a, multi-center, double-blind, placebo-controlled clinical study measuring the safety and efficacy of LP-10 for cancer survivors with hemorrhagic cystitis resulting from pelvic radiation therapy and/or systemic chemotherapy (Press release, Lipella Pharmaceuticals, MAR 26, 2019, View Source [SID1234534642]).

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Cancer survivorship is becoming an important priority for patients, caregivers and health care providers. Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers, in approximately 12% of patients, leads to chronic hemorrhagic cystitis that can be severe and uncontrollable. Certain chemotherapy agents can also cause hemorrhagic cystitis. There are no approved therapies to treat hemorrhagic cystitis, which can severely diminish a patient’s quality of life, and, in some cases lead to death.

LP-10 is a liposomal tacrolimus formulation under development for the treatment of hemorrhagic cystitis, an orphan indication with no currently approved therapies. "The approved protocol allows for dose escalation as well as a lipid vehicle control arm," stated Jonathan Kaufman, PhD, Chief Executive Officer of Lipella. "We are looking forward to the collection of additional human data, as we seek opportunities for future collaboration. Oncology supportive care is an important strategic direction for us, and we are excited to advance our clinical pipeline."

About LP-10

LP-10 is a proprietary product developed for intravesical delivery to hemorrhagic cystitis patients. LP-10 has received US FDA Orphan Designation.

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.