LIPELLA PHARMACEUTICALS INC. Lipella awarded $1.35m grant in 2022 for development of intravesical contrast-enhanced magnetic resonance imaging (ICE-MRI) technology.
PITTSBURGH, April 5, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces it has dosed the first patient in its human clinical study of a novel bladder MRI contrast agent.
Lipella's contrast agent is composed of two MRI contrast agents and is expected to be useful for the diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) and potentially other bladder diseases characterized by bladder wall defects. Lipella believes the agent may also have utility in detecting bladder tumor progression to muscle-invasive bladder cancer.
The study is being funded by a $1.35 million Small Business Innovation Research (SBIR) Phase II grant awarded to Lipella by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2022. The two-year grant will support the clinical development of intravesical contrast-enhanced magnetic resonance imaging (ICE-MRI) technology, and is expected to accelerate clinical development of ICE-MRI, which could lead to important clinical results.
Dr. Michael Chancellor, Chief Medical Officer of Lipella expressed excitement about the milestone in developing a novel MRI contrast agent that can evaluate and detect leaky bladder.
"As a urologist, I know my clinical colleagues would highly welcome a new objective diagnostic modality that can accurately measure impaired bladder permeability and function," said Dr. Chancellor.
Professor Pradeep Tyagi, a renowned scholar in the field of bladder pharmacology and imaging, emphasized that the agent can objectively phenotype IC/BPS that is bladder-centric, thereby identifying patients who would be most likely to benefit from clinical trials of newer therapies targeting bladder pathology and avoid the delay in getting appropriate medical care.
About ICE-MRI, a Duel-Component MRI Contrast Agent
ICE-MRI is a proprietary liquid solution/suspension composed of two MRI contrast agents with unique magnetic properties that can be used to determine if bladder permeability defects are present. Lipella has completed preclinical validation of the agent and has commenced human clinical trials. The novel contrast agent has a low cost of goods sold and a rapid diagnostic device development plan to meet urologic indications without current approved diagnostic imaging.
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 trading on Nasdaq under the ticker LIPO. 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 presentation regarding, among other things, our strategy, future operations, financial position, anticipated dividends, projected costs, 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 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. The Company expressly disclaims any and all liability relating to or resulting from the use of this presentation. 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lipella-pharmaceuticals-doses-first-patient-in-human-study-of-innovative-contrast-agent-301790313.html
SOURCE Lipella Pharmaceuticals Inc.
