Lipella Pharmaceuticals Received FDA IND Approval for Phase-2a Oncology Supportive Care Drug Study
LP-10, which has received FDA Orphan Drug designation, has now obtained IND approval for Phase-2a, multi-center, double-blind, controlled, clinical trial for hemorrhagic cystitis.
PITTSBURGH--(BUSINESS WIRE)-- Lipella Pharmaceuticals Inc., a clinical stage biopharmaceutical company based in Pittsburgh, PA, announced today 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.
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.”
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.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals Inc is a privately-held biotechnology company with a focus on supportive care to cancer survivors who acquire hemorrhagic cystitis, as well as improved surveillance and imaging of patients with a history of transitional cell carcinoma. More information is available at www.lipella.com.
Lipella Pharmaceuticals Inc.
Jonathan Kaufman, PhD
Source: Lipella Pharmaceuticals Inc.