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.”

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.

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.

Contacts

Lipella Pharmaceuticals Inc.
Jonathan Kaufman, PhD
(412)
894-1853
[email protected]