Hemorrhagic cystitis

SpikImm Announces the Signature of an Exclusive License Option and Collaboration Agreement With SATT Conectus for the Development of a Prophylactic Treatment Against the BK Virus, Causing Severe Complications in Transplant Patients

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星期二, 四月 16, 2024
COVID-19, Research, Infectious Diseases, Clinical Trials, Biotechnology, Other Health, Health, Other Science, Science, Infection, Antibody, University, Bone marrow, Pasteur Institute, BK, Hospital, Kidney, Risk, SARS-CoV-2, Viral, Heart, MD, Doctor of Philosophy, Vaccine, Life, BK virus, European, Disease, System, Transplant, ANR, Patient, Doctor of Pharmacy, CHU, Hemorrhagic cystitis, LFB, Immunodeficiency, BKV, Bladder cancer, University of Strasbourg

This agreement reinforces SpikImm's portfolio and expertise for the prophylactic treatment of viral infections in immunocompromised patients.

Key Points: 
  • This agreement reinforces SpikImm's portfolio and expertise for the prophylactic treatment of viral infections in immunocompromised patients.
  • BK virus (BKV) infects most individuals early in life and typically remains latent in the body without causing disease.
  • However, under immunosuppressive treatment, in particular in transplant patients, BKV can reactivate and replicate in the urinary tract, leading to potentially serious complications.
  • SpikImm and SATT Conectus today announced the signature of an exclusive option agreement for the anti-BKV monoclonal antibodies.

Lipella Pharmaceuticals Announces FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis

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星期三, 四月 3, 2024
Urinalysis, Type, HC, Patient, History, Tacrolimus, Urine, Ifosfamide, Nephrology, Breast cancer, Hemorrhagic cystitis, Safety, FDA, Cyclophosphamide, Food, Pharmaceutical industry

Lipella expects to meet with the FDA on May 21, 2024.

Key Points: 
  • Lipella expects to meet with the FDA on May 21, 2024.
  • HC is a serious, life-threatening form of gross hematuria (i.e.
  • Lipella published these results in the peer-reviewed journal, International Urology and Nephrology , in September 2023, and received preliminary guidance from the FDA regarding potential registration endpoints.
  • The company’s anticipated Type C meeting with the FDA will focus on reaching an agreement for the proposed Phase-2b trial design, which Lipella expects to be a 36-subject, prospective, double-blind, placebo-controlled study with a primary efficacy assessment derived from the reduction in patient-reported frequency of gross hematuria episodes over a seven-day period.

Lipella Pharmaceuticals to Present at PropThink Digital Investor Conference

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星期二, 二月 20, 2024
HC, Hemorrhagic cystitis, Tacrolimus, Q&A, Bladder cancer

the potential of therapies in late-stage development to replace existing, toxic standards of care.

Key Points: 
  • the potential of therapies in late-stage development to replace existing, toxic standards of care.
  • why hemorrhagic cystitis (HC) is a large, overlooked opportunity and where existing treatments stand.
  • Following the presentation, investors will have an opportunity to ask relevant questions through an interactive Q&A portal.
  • The webcast link will also be posted on the Investors section of Lipella’s company website , and archived following the event.

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

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星期三, 十二月 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.

Patient with Candida krusei Infection in Matinas BioPharma’s Oral MAT2203 Expanded Access Program Achieves Complete Clinical Resolution

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星期三, 十月 11, 2023
Hemorrhagic cystitis, Male, Urine, Physician, NYSE, Internal medicine, Doctor of Philosophy, Division, Aspergillosis, LNC, MD, Fungal infection, Infection, University, Diabetes, Expanded access, Fluconazole, Roflumilast, Heart failure, Triazole, Kidney disease, Moyamoya disease, Patient, Candida krusei, Pharmaceutical industry, Raid on Matina

This patient was treated under Matinas’ Expanded Access/Compassionate Use Program by Marisa H. Miceli, MD, Professor of Medicine, Specializing in Fungal Infections and Transplant Diseases, Division of Infectious Diseases, Internal Medicine, at the University of Michigan.

Key Points: 
  • This patient was treated under Matinas’ Expanded Access/Compassionate Use Program by Marisa H. Miceli, MD, Professor of Medicine, Specializing in Fungal Infections and Transplant Diseases, Division of Infectious Diseases, Internal Medicine, at the University of Michigan.
  • “We are thrilled with the positive clinical impact MAT2203 had on this extremely ill patient with limited treatment options,” said Dr. Miceli.
  • Treatment with MAT2203 led to complete resolution of his symptoms and improvement of his kidney function to baseline.
  • We are grateful to the participants in our Expanded Access program and to their physicians for recognizing the clinical potential of MAT2203 in treating a broad spectrum of invasive fungal infections.”
    MAT2203 is not yet licensed or approved anywhere globally.

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

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星期一, 五月 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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星期一, 四月 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.

AlloVir Announces Positive Final Results in Phase 2 Posoleucel Multi-Virus Prevention Study In Oral Presentation at the 64th ASH Annual Meeting and Exposition

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星期六, 十二月 10, 2022
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Post, Hospital, Society, Disease, GVHD, EST, Infrastructure as code, Patient, COVID-19, Human polyomavirus 2, University of Kansas Medical Center, EBV, Valganciclovir, HC, Risk, Cytomegalovirus, Virus, City, Infection, Immunodeficiency, BK, JC, Lymphocytopenia, Degenerative disease, BK virus, Polymerase chain reaction, University, Letermovir, Blood, ELISpot, Antigen, Webcast, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCT, Death, PCR, BKV, CMV, Cytokine release syndrome, ASH, ADV, Annual report, JCV, European Medicines Agency, Division, FDA, Hemorrhagic cystitis, Safety, Biomarker, Vaccine, Pharmaceutical industry, Viremia

Biomarker data demonstrated the persistence of posoleucel and association between expansion of functional virus-specific T cells (VSTs) and viral control.

Key Points: 
  • Biomarker data demonstrated the persistence of posoleucel and association between expansion of functional virus-specific T cells (VSTs) and viral control.
  • These data were highlighted in an oral presentation ( Abstract 362 ) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans today.
  • Allogeneic hematopoietic cell transplant recipients are highly vulnerable to potentially devastating viral infections, particularly in the first 100-180 days post-transplant.
  • We are excited to see the durability of posoleucel efficacy and safety in this final data set from the Phase 2 multi-virus prevention study, which reinforces the preliminary data previously reported.

AlloVir Reports Second Quarter 2022 Financial Results

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星期四, 八月 4, 2022
Health, Infectious Diseases, Clinical Trials, General Health, Pharmaceutical, Biotechnology, EBV, Baylor University, Private Securities Litigation Reform Act, Annual report, COVID-19, Compassion, Food, Center, Survival, Nasdaq, Viral load, Infection, Hemorrhagic cystitis, Risk, European Patent Convention, Safety, FDA, Adult, CMV, JC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ATC, Â, BK, European Patent Office, Viremia, Center for International Blood and Marrow Transplant Research, Degenerative disease, VST, Patient, LinkedIn, Report, BK virus, Twitter, Mortality, ADV, Awareness, European Medicines Agency, BKV, Virus, HBV, HCT, Trial of the century, Cytomegalovirus, Company, Society, Immunodeficiency, JCV, Baylor College of Medicine, Science, Research, Conditional sentence, Human polyomavirus 2, SEC, VHC, Population, Vaccine, Pharmaceutical industry, Dentistry, Lithium, Transplant

AlloVir, Inc. (Nasdaq: ALVR), a multiple Phase 3 clinical trial stage allogeneic T cell immunotherapy company, today reported financial results for the second quarter ended June 30, 2022.

Key Points: 
  • AlloVir, Inc. (Nasdaq: ALVR), a multiple Phase 3 clinical trial stage allogeneic T cell immunotherapy company, today reported financial results for the second quarter ended June 30, 2022.
  • Research and development expenses were $31.4 million for the quarter ended June 30, 2022, compared with $25.7 million for the quarter ended June 30, 2021.
  • General and administrative expenses were $13.2 million for the quarter ended June 30, 2022, compared with $12.0 million for the quarter ended June 30, 2021.
  • Stock-based compensation expense was $11.0 million and $9.7 million for the quarter ended June 30, 2022 and 2021, respectively.

Announcing Radiation (and Hemorrhagic) Cystitis Patient Registry: for people affected by pelvic radiation during cancer treatment

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星期二, 五月 10, 2022
National Cancer Institute, Prostate, GLOBE, Radiation, Male, Attention, Cancer, Hemorrhagic cystitis, MD, History, Natural history, Female, Survivor, Life, Awareness, National Institute, Medical imaging

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.

Key Points: 
  • 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.
  • 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.
  • 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.