The post A Message from Our CEO, Dr. Jonathan Kaufman appeared first on Lipella Pharmaceuticals, Inc..
]]>As the CEO of Lipella Pharmaceuticals, I am proud to share our progress over the past year in advancing our clinical pipeline, highlighting our commitment to addressing significant unmet medical needs and providing supportive treatments to improve the lives of cancer survivors.
We focus on areas where patients’ needs are largely unaddressed. These conditions we target include hemorrhagic cystitis, oral lichen planus, and oral Graft-versus-Host Disease (GvHD). These conditions pose severe health risks, and can significantly diminish the quality of life for those affected. Our mission is to develop safe and effective therapies for these underserved populations.
We have been granted Orphan Drug Designation by the FDA for two of our drug candidates. The first for LP-10 in the treatment of hemorrhagic cystitis, and the second for LP-410, aimed at treating oral GvHD, a serious rare disease. These designations underscore our dedication to provide effective treatment options for rare diseases.
Looking ahead, our focus remains on progressing through the clinical development phases efficiently and effectively. This focus includes our strategy to leverage existing pharmacologic mechanisms to expedite the approval process and bring our therapies to patients sooner.
We are excited by the potential of our expanded clinical pipeline, which we believe provides a strong value proposition for our investors and to potential partners. We look forward to pipeline progress and potential expansion in the near future.
Thank you to our patients, partners, and investors. Together, we are on a clear path to transforming the treatment landscape for serious and rare diseases, improving patient outcomes, and delivering value to our stakeholders.
Warm regards,
Jonathan Kaufman
CEO, Lipella Pharmaceuticals
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]]>The post Lipella Pharma Sees Positive Results for LP-10 Phase 2a Trial appeared first on Lipella Pharmaceuticals, Inc..
]]>PITTSBURGH, Jan. 11, 2023 /MarketWatch/
Lipella Pharmaceuticals Inc. said it saw positive top-line results from its recently completed Phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for hemorrhagic cystitis.
The biotechnology company said its next step will be to communicate with the Food and Drug Administration on the study’s results and the pathway forward to seeking regulatory approval for LP-10.
The study recruited 13 subjects with moderate to severe refractory hemorrhagic cystitis. These subjects were treated with up to two courses of LP-10 intravesical bladder instillations.
All subjects tolerated the LP-10 instillations and completed the study without report of product-related serious adverse events. LP-10 pharmacokinetic analysis demonstrated short duration of systemic uptake, decreased cystoscopic bleeding and ulceration sites, and improved patients’ urinary symptoms.
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]]>The post Lipella Pharmaceuticals Announces Pricing of Initial Public Offering of Common Stock appeared first on Lipella Pharmaceuticals, Inc..
]]>PITTSBURGH, Dec. 19, 2022 /PRNewswire/ — Lipella Pharmaceuticals, Inc. (“Lipella,” “our, “us” or the “Company”), 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, today announced the pricing of its initial public offering of 1,217,391 shares of its common stock at a price to the public of $5.75 per share. The gross proceeds from the offering to Lipella, before deducting underwriting discounts and other offering expenses payable by Lipella, are expected to be approximately $7 million. In addition, the underwriters have been granted a 45-day option to purchase up to an additional 182,608 shares of common stock, at the initial public offering price, less underwriting discounts.
The shares are expected to begin trading on The Nasdaq Capital Market on December 20, 2022, under the ticker symbol “LIPO” and the offering is expected to close on December 22, 2022, subject to customary closing conditions.
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]]>The post Announcing Radiation (and Hemorrhagic) Cystitis Patient Registry appeared first on Lipella Pharmaceuticals, Inc..
]]>Pittsburgh, PA – (May 9, 2022) – Lipella Pharmaceuticals, Inc. is announcing the Radiation Cystitis Patient Registry, an on-line patient registry program for people who are affected by pelvic radiation exposure, including survivors of pelvic cancers, such as prostate, uterine, cervical and colon cancer. “Despite its challenges, life after cancer can be beautiful and meaningful,” says Michael Chancellor, MD, Chief Medical Officer of Lipella Pharmaceuticals. “As the country prepares to celebrate National Cancer Survivors Day, our primary motivation is to raise awareness of radiation cystitis and hemorrhagic cystitis, serious survivor issues that deserve more attention,” says Dr. Chancellor.
Radiation cystitis, also called hemorrhagic cystitis, is a highly debilitating consequence of pelvic cancer radiotherapy. The radiation cystitis patient registry will help raise awareness within the medical community, highlight the needs of survivors, and help advance the development of new treatments. There are currently no drug therapies available for either hemorrhagic cystitis or radiation cystitis.
Where to find the Radiation Cystitis Patient Registry. The Radiation Cystitis Patient Registry can be found at https://radiationcystitis.com. More information can also be found via the Radiation Cystitis Foundation at https://www.radiationcystitis.org.
About the Radiation Cystitis Patient Registry (https://radiationcystitis.com) The registry, designed in accordance with the National Institute of Health Rare Diseases Registry Program guidelines, is open to male and female pelvic cancer survivors with a history of pelvic radiotherapy. The registry’s primary objective is to better describe hemorrhagic cystitis and radiation cystitis’ natural history, and therefore improve the development of novel treatments. Since radiation cystitis and hemorrhagic cystitis are rare, tools that help describe their natural progression can optimize the design of successful clinical programs.
About Lipella Pharmaceuticals Inc. Lipella Pharmaceuticals Inc. is a clinical-stage pharmaceutical company with expertise in drug delivery and the treatment of urologic conditions, including radiation cystitis and hemorrhagic cystitis.
Contacts
Janet Okonski
Director of Clinical Operations
Lipella Pharmaceuticals Inc.
412-894-1853
Email
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]]>The post Lipella Pharmaceuticals Announces Successful Completion of Pre-IND Type B FDA Meeting Regarding Oral Lichen Planus Drug Candidate appeared first on Lipella Pharmaceuticals, Inc..
]]>Pittsburgh, PA – (May 11, 2021) – Lipella Pharmaceuticals Inc., a clinical stage pharmaceutical company based in Pittsburgh, PA, announced today that the company has successfully concluded a Type B pre-Investigational New Drug (IND) meeting communication with the U.S. Food and Drug Administration (FDA) for LP-310, a drug candidate for treating oral lichen planus (OLP).
Oral lichen planus is a chronic inflammatory mucosal disease that affects more than 6 million people in the U.S. and Europe. The disease is typically characterized by ulcerative lesions in the oral cavity, accompanied by inflammation and severe pain. Also, patients with OLP have a higher frequency of transformation into oral cancer, making early detection and treatment an imperative. There are currently no approved drug treatments for OLP.
“Meeting with the FDA for this pre-IND application was an important step toward allowing a Phase II clinical trial to assess both the safety and efficacy of LP-310,” stated Jonathan Kaufman, Ph.D., Chief Executive Officer of Lipella. “We are very excited because this progress advances our capacity to develop a safe and effective therapy a serious disease with great unmet need.”
About LP-310
LP-310 is a liposomal tacrolimus formulation for local oral rinse administration to treat OLP.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals Inc. is a clinical stage pharmaceutical company with a focus on capital efficient therapeutic development opportunities, including the proprietary repositioning of generics for rare, morbid diseases that currently have no adequate treatments. Additional information is available at www.lipella.com.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are only predictions and involve known and unknown risks, uncertainties, and other factors.
Contacts
Allison Houck
Lipella Pharmaceuticals Inc.
412-894-1853
[email protected]
Source: Lipella Pharmaceuticals Inc.
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]]>The post Bladder Health Foundation Launches Patient Registry for Survivors of Pelvic Radiation Therapy appeared first on Lipella Pharmaceuticals, Inc..
]]>Pittsburgh, PA – (April 30, 2021) – The Bladder Health Foundation announces the rollout of the first on-line patient registry for pelvic radiation cancer survivors. The online registry is located at www.radiationcystitis.org.
The Bladder Health Foundation, with support from Lipella Pharmaceuticals Inc., is promoting the awareness of a serious bladder health condition, hemorrhagic cystitis, which affects many cancer survivors who received pelvic radiation, including survivors of prostate, uterine/cervical and colon cancers. Hemorrhagic cystitis symptoms including painful urinary bleeding.
About the Bladder Health Foundation.
Created in 2012, the Bladder Health Foundation has been promoting awareness of bladder conditions with unmet needs including: interstitial cystitis, radiation cystitis, underactive bladder and neurogenic bladder dysfunction. These urologic morbidities can significantly affect the quality of life for cancer survivors.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals Inc. is a clinical stage pharmaceutical company with a focus on capital efficient therapeutic development opportunities, including the proprietary repositioning of generics for rare, morbid diseases that currently have no adequate treatments, including hemorrhagic cystitis.
Contacts
Allison Houck
Lipella Pharmaceuticals Inc.
412-894-1853
Email
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]]>The post National Bladder Awareness Month: A Look at the Facts about Pelvic Radiation Cancer Survivors appeared first on Lipella Pharmaceuticals, Inc..
]]>Lipella Pharmaceuticals promotes awareness of hemorrhagic cystitis, a chronic painful syndrome that can be acquired by cancer patients who have received pelvic radiation therapy.
PITTSBURGH, November 12, 2020 – During this November, Bladder Health Awareness Month, we promote the awareness of a serious bladder health condition, hemorrhagic cystitis, which affects many cancer survivors who received pelvic radiation. Patients with bladder damage after pelvic radiation include survivors of prostate, uterine/cervical and colon cancers. Hemorrhagic cystitis symptoms including painful urinary bleeding.
“During bladder awareness month we want to raise awareness regarding the effects of long-term radiation damage,” commented Jonathan Kaufman, Lipella’s Chief Executive Officer. “Hemorrhagic cystitis is a serious condition that can significantly affect quality of life for cancer survivors.”
“Radiation and chemotherapy, while helping to cure cancer, can also cause long-term damage that is difficult to treat with existing options.” commented Mr. George Harriston, President of the Radiation Cystitis Foundation.
About Hemorrhagic Cystitis
Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers can cause chronic, painful urinary inflammation and blood loss called 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. There are currently no adequate therapies available for the treatment of moderate to severe hemorrhagic cystitis patients.
Additional Facts about Hemorrhagic Cystitis
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals Inc. is a clinical stage pharmaceutical company with a focus on capital efficient therapeutic development opportunities, including the proprietary repositioning of generics for rare, morbid diseases that currently have no adequate treatments, including hemorrhagic cystitis. Lipella has begun recruiting patients in the company’s phase 2a clinical trial to study the dose-dependent, safety and efficacy of LP-10 (liposomal tacrolimus) for the treatment of hemorrhagic cystitis. Additional information is available at www.lipella.com. 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause Lipella’ results and the timing of certain events to differ materially from those discussed in the forward-looking statements, including risks associated with clinical development, regulatory approvals, product commercialization, intellectual property claims and litigation and other risks. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors.
Contacts
Allison Houck
Lipella Pharmaceuticals Inc.
412-894-1853
Email
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]]>The post Lipella Pharmaceuticals Initiates its Phase-2a Clinical Trial of LP-10 for Hemorrhagic Cystitis appeared first on Lipella Pharmaceuticals, Inc..
]]>A multi-site, prospective, open-label, dose-escalation clinical trial assessing the safety and efficacy of LP-10 (liposomal tacrolimus) is now open for recruitment at several sites.
PITTSBURGH, October 15, 2020 (BUSINESS WIRE) – Lipella Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on improving cancer survivorship, today announced it has begun recruiting patients in the company’s phase 2a clinical trial to study the dose-dependent, safety and efficacy of LP-10 (liposomal tacrolimus) for the treatment of hemorrhagic cystitis.
“We are encouraged to be able to provide LP-10 to qualified patients,” commented Jonathan Kaufman, Lipella’s Chief Executive Officer. “Two clinical sites have started patient screening and recruitment, and we look forward to opening additional sites in the near future.”
About Hemorrhagic Cystitis
Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers can cause chronic, painful urinary inflammation and blood loss called 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. There are currently no adequate therapies available for the treatment of moderate to severe hemorrhagic cystitis patients.
About LP-10
LP-10 is a proprietary liposomal formulation of tacrolimus that is currently being evaluated as a treatment for moderate to severe hemorrhagic cystitis. Lipella Pharmaceuticals received FDA Orphan Designation for the use of tacrolimus for the treatment of hemorrhagic cystitis.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals Inc. is a clinical stage pharmaceutical company with a focus on capital efficient therapeutic development opportunities, including the proprietary repositioning of generics for rare, morbid diseases that currently have no adequate treatments. Additional information is available at https://lipella.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause Lipella’s results and the timing of certain events to differ materially from those discussed in the forward-looking statements, including risks associated with clinical development, regulatory approvals, product commercialization, intellectual property claims and litigation and other risks. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors.
Contacts
Allison Houck
Lipella Pharmaceuticals Inc.
412-894-1853
Email
The post Lipella Pharmaceuticals Initiates its Phase-2a Clinical Trial of LP-10 for Hemorrhagic Cystitis appeared first on Lipella Pharmaceuticals, Inc..
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