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
This press release includes
certain "forward-looking statements." All statements, other than
statements of historical fact, included in this press release
regarding, among other things, our strategy, future operations,
financial position, prospects, pipeline and opportunities, sources
of growth, successful implementation of our proprietary technology,
plans and objectives are forward-looking statements.
Forward-looking statements can be identified by words such as
"may," "will," "could," "continue," "would," "should," "potential,"
"target," "goal," "anticipates," "intends," "plans," "seeks,"
"believes," "estimates," "predicts," "expects," "projects" and
similar references to future periods. Forward-looking statements
are based on our current expectations and assumptions regarding
future events and financial trends that we believe may affect among
other things, our financial condition, results of operations,
business strategy, short- and long-term business operations and
objectives, and financial needs. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict.
Our actual results may differ materially from those contemplated by
the forward-looking statements. We caution you, therefore, against
relying on any of these forward-looking statements. They are
neither statements of historical fact nor guarantees or assurances
of future performance. There are risks, uncertainties and other
factors, both known and unknown, that could cause actual results to
differ materially from those in the forward-looking statements
which include, but are not limited to, regional, national or global
political, economic, business, competitive, market and regulatory
conditions, and other factors. Any forward-looking statement made
by us is based upon the reasonable judgment of our management at
the time such statement is made and speaks only as of the date on
which it is made. Factors or events that could cause our actual
results to differ may emerge from time to time, and it is not
possible for us to predict all of them. We undertake no obligation
to update any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by applicable law. Nothing contained herein is, or shall
be relied upon as, a promise or representation as to the past or
future. In addition, the information contained in this press
release is as of the date hereof, and the Company has no obligation
to update such information, including in the event that such
information becomes inaccurate. You should not construe the
contents of this press release as legal, tax and financial advisors
as to legal and related matters concerning the matters described
herein.
CONTACT
Chuck Harbey
PCG Advisory
charbey@pcgadvisory.com
646.863.6341
View original content to download
multimedia:https://www.prnewswire.com/news-releases/lipella-pharmaceuticals-delivers-late-breaking-presentation-at-the-american-urological-association-annual-meeting-301811485.html
SOURCE Lipella Pharmaceuticals Inc.