LIPO

Lipella Pharmaceuticals Announces Completion of Site Initiation Visit for Phase 2a Trial of LP-310 in Oral Lichen Planus

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Vendredi, mai 31, 2024
Toxicity, FDA, Male, OLP, Safety, LIPO, Tacrolimus, SIV, Institutional review board, Pain, Lichen planus, IRB, Female, Pharmaceutical industry

PITTSBURGH, May 31, 2024 (GLOBE NEWSWIRE) -- 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 the successful completion of its first Site Initiation Visit (SIV) for the Phase 2a trial evaluating LP-310 in the treatment of Oral Lichen Planus (OLP). With clearance received from the central Institutional Review Board (IRB), the Phase 2a trial is set to commence with site qualifications completed and patient recruitment underway.

Key Points: 
  • Patient recruitment is underway for Phase 2a multicenter, dose-ranging study
    PITTSBURGH, May 31, 2024 (GLOBE NEWSWIRE) -- 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 the successful completion of its first Site Initiation Visit (SIV) for the Phase 2a trial evaluating LP-310 in the treatment of Oral Lichen Planus (OLP).
  • With clearance received from the central Institutional Review Board (IRB), the Phase 2a trial is set to commence with site qualifications completed and patient recruitment underway.
  • Lipella’s Phase 2a trial is a multicenter, dose-ranging study involving adult male and female subjects experiencing symptomatic OLP.
  • Dr. Jonathan Kaufman, CEO of Lipella, expressed his enthusiasm, stating, “We are extremely pleased to announce the completion of the Site Initiation Visit for our Phase 2a trial of LP-310.

Lipella Pharmaceuticals Announces Abstract Publication at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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Mercredi, mai 29, 2024
NMIBC, Society, American Cancer Society, LIPO, ASCO, Bladder cancer, Administration, Dietary supplement

PITTSBURGH, May 29, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces an abstract publication at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, taking place from May 31 - June 4 in Chicago, IL, and online.

Key Points: 
  • PITTSBURGH, May 29, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces an abstract publication at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, taking place from May 31 - June 4 in Chicago, IL, and online.
  • Lipella’s abstract, titled “Intravesical Administration of Pembrolizumab for Bladder Tumor- A Potential Strategy to Minimize Drug Toxicity” highlights new preclinical results from LP-50 (intravesical pembrolizumab) in induced murine non-muscle invasive bladder cancer (NMIBC).
  • Lipella Pharmaceuticals Chief Medical Officer, Dr. Michael Chancellor, said, “LP-50 is an intravesical formulation intended for the treatment of non-muscle invasive bladder cancer.
  • Our preclinical results have demonstrated promising results, demonstrating LP-50’s potential for increasing efficacy while minimizing systemic toxicity.”
    The American Cancer Society estimates that there will be 83,190 new cases of bladder cancer diagnosed in the United States in 2024.

Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b

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Mardi, mai 21, 2024
Patient, Clutch (eggs), Food and Drug Administration, FDA, LIPO, Hemorrhagic cystitis, Tacrolimus, Hematuria, Pharmaceutical industry

PITTSBURGH, May 21, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (NASDAQ: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, announced today the receipt of U.S. Food & Drug Administration (“FDA”) Type-C meeting guidance regarding the LP-10 (liposomal tacrolimus) clinical program.

Key Points: 
  • PITTSBURGH, May 21, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (NASDAQ: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, announced today the receipt of U.S. Food & Drug Administration (“FDA”) Type-C meeting guidance regarding the LP-10 (liposomal tacrolimus) clinical program.
  • Lipella expects to initiate a Phase 2b clinical trial evaluating LP-10 as a treatment for hemorrhagic cystitis in approximately 36 patients in the second half of 2024.
  • The FDA provided preliminary agreement on Lipella’s overall trial design, including objectives, safety monitoring, control group monitoring, the dosing protocol, the primary efficacy endpoint, and sample size considerations.
  • Lipella’s Chief Medical Officer, Dr. Michael Chancellor, stated, “We can now proceed with the confidence that our Phase 2b study design can successfully meet its regulatory objectives.

Lipella Pharmaceuticals Expands its Advisory Board to Include Oncology Expertise

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Mercredi, avril 17, 2024
Wilfrid Sellars, University, DDS, LIPO, DRS, Disease, MPH, NMIBC, MBA

PITTSBURGH, Pa., April 17, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, today announced the expansion of its Scientific Advisory Board to include oncology expertise.

Key Points: 
  • PITTSBURGH, Pa., April 17, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, today announced the expansion of its Scientific Advisory Board to include oncology expertise.
  • The new committee members are: Jason Hafron, MD, DDS, PhD, MPH, the Chief Medical Officer at Michigan Institute of Urology, and Professor of Urology at the William Beaumont School of Medicine; and Pradeep Tyagi, PhD, MBA, Professor of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA. Drs.
  • Hafron and Tyagi have complementing expertise in both clinical and translational research in cancer treatment, with a focus on urologic oncology.
  • Dr. Michael Chancellor, M.D., Chief Medical Officer of Lipella, stated, “I look forward to working with Dr. Hafron and Dr. Tyagi in the advancement of our discovery efforts in the treatment of non-muscle invasive bladder cancer (NMIBC), a disease that affects nearly one million Americans.”

Lipella Pharmaceuticals to Publish Abstract Detailing Compelling Preclinical Support for New Product Candidate at ASCO 2024

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Vendredi, avril 5, 2024
NMIBC, Patient, Mouse, Cancer, Bladder cancer, LIPO, Pembrolizumab, Society, ASCO, Therapy, Physician

Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .

Key Points: 
  • Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .
  • Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, said, “ASCO’s 2024 meeting is the ideal venue for dissemination of our recent progress in the treatment of bladder cancer.
  • Lipella’s new product candidate, LP-50 (intravesical pembrolizumab), is intended to be indicated for non-muscle invasive bladder cancer (NMIBC).
  • Dr. Michael Chancellor, Lipella’s Chief Medical Officer, emphasized the significance of this milestone for advancing the company’s LP-50 program.

Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished

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Mercredi, décembre 20, 2023
Hemorrhagic cystitis, Food, LIPO, IND, FDA, Type, OLP, IRB, Tacrolimus, HC, GVHD, Growth, Lichen planus, Pharmaceutical industry

PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.

Key Points: 
  • PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.
  • Based in Pittsburgh, PA, the Company has made substantial strides over the past year, achieving critical milestones and advancing its pipeline with three clinical indications and two orphan drug designations granted.
  • Additionally, Lipella's LP-310 has been granted orphan drug designation for the treatment of oral graft-versus-host disease (GVHD) with tacrolimus.
  • The Company is poised to submit a Phase 2a IND for this indication in the first quarter of 2024.

FDA Grants Orphan Designation for Lipella's LP-310 Drug Candidate for Oral Graft-versus-Host Disease

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Vendredi, novembre 10, 2023
Disease, Safety, Cancer, Food, Risk, Patient, LIPO, FDA, Graft-versus-host disease, Diagnosis, Orphan, Quality of life, Fibrosis, Pharmaceutical industry, Dentistry

PITTSBURGH, Nov. 10, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical stage pharmaceutical company addressing serious diseases with significant unmet need based in Pittsburgh, PA, announced today that it has been granted "Orphan Drug Designation" from the U.S. Food and Drug Administration (FDA) for its drug candidate, LP-310, which has been designed for the treatment of oral Graft-versus-Host Disease (GvHD). 

Key Points: 
  • LP-310 is Lipella's clinical stage pipeline asset intended to be indicated for inflammatory diseases of the oral cavity, including oral lichen planus and oral GvHD.
  • LP-310 liposomal tacrolimus is a proprietary oral rinse formulation of Lipella's lead drug candidate, LP-10.
  • Dr. Jonathan Kaufman, Ph.D., Chief Executive Officer of Lipella, said, "We are very pleased to have received Orphan Drug Designation for LP-310 in oral GvHD.
  • Lipella's LP-10 was previously granted Orphan Drug Designation by the FDA, making LP-310 the second of Lipella's leading product candidates to receive this designation.

Lipella Pharmaceuticals Delivers Late-Breaking Presentation at the American Urological Association Annual Meeting

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Lundi, mai 1, 2023
AUA, LIPO, Clinical trial, American Urological Association, Prostate, Hemorrhagic cystitis, Patient, Cancer, Kidney, FDA, Urology, Hematuria, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • 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.
  • Lipella Pharmaceuticals CEO, Dr. Jonathan Kaufman, added, "We are very pleased to have successfully completed our Phase 2a clinical trial.
  • Lipella anticipates scheduling a Type B meeting with the FDA regarding this program in the next few months.

Lipella Pharmaceuticals Enters Manufacturing Collaboration Agreement with Cook MyoSite

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Lundi, avril 17, 2023
GMP, Good, Partnership, Good manufacturing practice, CMC, LIPO, Hemorrhagic cystitis, Documentation, Patient, Control, Orphan, Knowledge, FDA, IND, Pharmaceutical industry, Chemistry

PITTSBURGH, April 17, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into a manufacturing collaboration agreement with Cook MyoSite, Inc. ("Cook MyoSite") to facilitate Chemistry, Manufacturing, and Control ("CMC") documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA.

Key Points: 
  • PITTSBURGH, April 17, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into a manufacturing collaboration agreement with Cook MyoSite, Inc. ("Cook MyoSite") to facilitate Chemistry, Manufacturing, and Control ("CMC") documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis.
  • The collaboration with Cook MyoSite, a company with 19 years of Good Manufacturing Practice ("GMP") manufacturing expertise, is expected to greatly accelerate Lipella's ability to bring new treatments to patients with unmet needs.
  • He emphasized that the collaboration with Cook MyoSite will play a crucial role in advancing the commercial approval of LP-10.
  • With this collaboration, Lipella and Cook MyoSite are poised to make a greater impact in addressing the significant unmet need for effective treatments for hemorrhagic cystitis, and further advance LP-10 towards regulatory approval.

Lipella Pharmaceuticals Doses First Patient in Human Study of Innovative Contrast Agent

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Mercredi, avril 5, 2023
NIDDK, SBIR, LIPO, National Institute of Diabetes and Digestive and Kidney Diseases, Cancer, Trial of the century, IC/BPS, MRI, Kidney, Bladder cancer, Patient, Small Business Innovation Research, Diagnosis, Digestive, Pharmacology, Medical imaging

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.

Key Points: 
  • 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.
  • 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.