Latest news with #neuroinflammation
National Post
5 days ago
- Business
- National Post
Fujirebio Expands Its Neuro Testing Portfolio With the Launch of the Fully Automated Lumipulse® G sTREM2 Assay for Research Use Only
Article content GENT, Belgium & MALVERN, Pa. & TOKYO — H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G sTREM2 assay for the fully automated LUMIPULSE® G immunoassay analyzers. This CLEIA (chemiluminescent enzyme immunoassay) assay is available for Research Use Only (RUO) and allows for the quantitative measurement of soluble Triggering Receptor Expressed on Myeloid Cells 2 (sTREM2) in human cerebrospinal fluid (CSF) and blood within just 35 minutes. Article content sTREM2 is a promising biomarker of microglial activation, offering researchers insights into neuroinflammation linked to Alzheimer's and other neurodegenerative diseases. sTREM2 can be valuable for capturing the dynamics of inflammatory responses or for monitoring inflammatory modulators. This test complements Fujirebio's growing portfolio of neuro biomarkers, including GFAP, NfL, and pTau, and reinforces the company's leading position in advancing neuro biomarker research tools and diagnostics. Article content Article content 'By adding sTREM2 to our neuro portfolio, we're enabling a more comprehensive view of neurological disease mechanisms,' Article content said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. 'sTREM2 complements established biomarkers like GFAP, NfL, and pTau by adding essential insight into neuroinflammation – offering a more complete picture of the disease on a single platform.' Article content The new test allows researchers and clinical research professionals to further study and understand the potential clinical utility of this promising microglial biomarker. The availability of the assay on the fully automated random access LUMIPULSE G analyzers gives researchers access to convenient, accurate, and robust measurement of sTREM2. Already widely available for routine use in neurological disease testing worldwide, these analyzers meet all necessary quality, throughput, and regulatory requirements. Article content About Fujirebio Article content Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality RUO and in vitro diagnostics (IVD) testing. It has more than 50 years' accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Article content Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio offers a comprehensive line-up of manual and fully automated assays for neurological diseases and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. Article content Article content Article content Email: Article content pr@ Article content For investors and analysts: Article content Article content IR/SR Dept. Article content Article content Article content
Medscape
20-05-2025
- Health
- Medscape
BBB Injury and Neuroinflammation in Eclampsia
Eclampsia was associated with distinct cerebrospinal fluid (CSF) biomarker profiles, indicating severe disruption of the blood-brain barrier (BBB) and increased neuroinflammation. METHODOLOGY: This investigation focused on BBB injury and neuroinflammation to elucidate mechanisms underlying cerebral injury. A total of 129 women from the Pre-eclampsia Obstetric Adverse Events biobank in South Africa who underwent caesarean delivery between March 2021 and June 2023 were included, of whom 11 had eclampsia, 17 had preeclampsia with end-organ complications, 88 had preeclampsia without end-organ complications, and 13 had normotensive pregnancies. An observational cross-sectional design was used; participants were stratified on the basis of the severity of preeclampsia (with end-organ complications). CSF and plasma samples were collected during spinal anaesthesia; CSF concentrations of claudin-5 and matrix metalloproteinase-9 and the CSF/plasma albumin ratio were measured; cytokine and chemokine levels were measured using the multiplex Bio-Plex assay. BBB injury markers and cytokine levels were compared using the analysis of covariance. Secondary outcomes included correlation analyses between CSF and plasma biomarkers. TAKEAWAY: Women with eclampsia showed 2.7-fold higher claudin-5 concentrations in CSF than those with normotensive pregnancies ( P = .005), with concentrations 4.0-fold higher than those with preeclampsia and end-organ complications and 3.1-fold higher than those with preeclampsia without end-organ complications. = .005), with concentrations 4.0-fold higher than those with preeclampsia and end-organ complications and 3.1-fold higher than those with preeclampsia without end-organ complications. Interleukin (IL)-6 levels were significantly elevated (20.7-fold; P < .001); IL-8 (7.2-fold; P < .001) and IL-10 (2.0-fold; P = .004) levels were also increased. < .001); IL-8 (7.2-fold; < .001) and IL-10 (2.0-fold; = .004) levels were also increased. No correlation was observed between CSF and plasma cytokine levels ( P > .05), but strong associations were noted between IL-6 and IL-8 levels (r = 0.74). > .05), but strong associations were noted between IL-6 and IL-8 levels (r = 0.74). Stem cell factor levels were significantly lower in women with eclampsia (0.5-fold decrease; P = .005) than in those with normotensive pregnancies; leukaemia inhibitory factor levels were 3.8-fold higher in those with eclampsia than in those with preeclampsia without end-organ complications. = .005) than in those with normotensive pregnancies; leukaemia inhibitory factor levels were 3.8-fold higher in those with eclampsia than in those with preeclampsia without end-organ complications. Monocyte chemoattractant protein-1 levels were 4.3-fold higher in women with eclampsia than in those with preeclampsia with end-organ complications; interferon-gamma levels were 2.9-fold higher in those with eclampsia than in those with preeclampsia and end-organ complications; IL-10 levels were 2.0-fold higher in those with eclampsia than in those with preeclampsia without end-organ complications. IN PRACTICE: "Women with eclampsia experience acute neuroinflammation and blood-brain barrier injury, comparable to patterns observed in neurodegenerative diseases such as acute traumatic brain injury, stroke or Alzheimer's disease. Clinical follow-up of women with eclampsia postpartum should be considered," the authors of the study wrote. SOURCE: This study was led by Valentina Bucher, PhD, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. It was published online on May 08, 2025, in eBioMedicine . LIMITATIONS: This study was limited by the fact that samples were collected only after the onset of eclampsia, preventing the determination of whether BBB injury and neuroinflammation were causes or consequences of seizures. Despite having a substantial number of women with eclampsia, the small absolute number may have limited statistical power and introduced false-negative results. DISCLOSURES: This study was supported by the Swedish Research Council, Herbert och Karin Jacobssons Stiftelse, Wilhelm and Martina Lundgrens Foundations, and Swedish Society of Medicine. Some authors reported serving at scientific advisory boards and/or as consultants for several pharmaceutical organisations.
Yahoo
20-05-2025
- Business
- Yahoo
Brainstorm Cell Therapeutics Inc (BCLI) Q1 2025 Earnings Call Highlights: Pivotal Phase 3b ...
Phase 3b Trial Initiation: FDA clearance received to initiate pivotal Phase 3b trial for NurOwn. Manufacturing and Site Selection: Initial manufacturing at Tel Aviv Sourasky Medical Center; technology transfer to Pluri for additional facilities. Clinical Trial Agreements: Negotiations with approximately 15 leading clinical centers in the U.S. for Phase 3b trial sites. Trial Design: Phase 3b trial includes a 24-week double-blind period followed by a 24-week open-label extension. Primary Endpoint: Change from baseline to week 24 in ALSFRS-R total score. Biomarker Analysis: NurOwn associated with reduction in neuroinflammatory and neurodegenerative biomarkers. Genetic Substudy: UNC13A genotype may influence response to NurOwn therapy. Warning! GuruFocus has detected 2 Warning Signs with BCLI. Release Date: May 19, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. The U.S. FDA has cleared Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) to initiate a pivotal Phase 3b trial for NurOwn, marking a significant milestone in their ALS treatment development. The trial design has been agreed upon with the FDA under a special protocol assessment (SPA), which de-risks the regulatory pathway for NurOwn. Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) has secured a leading U.S. clinical site that has passed FDA inspection, enhancing their operational readiness for the upcoming trial. The company is actively engaged in negotiations with approximately 15 leading clinical centers across the United States for the Phase 3b trial, indicating strong interest from the ALS research community. Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) is pursuing multiple funding avenues, including a promising $15 million non-dilutive grant, to ensure the timely commencement of the trial. The company faces significant financial constraints, which are common in the biotech industry, and securing proper funding is essential to commence the trial. The initiation and successful execution of the clinical trial demand a robust and sustainable cash flow, which is currently a challenge for Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI). The company has not yet signed clinical trial agreements (CTAs) with the clinical centers, which could delay the trial's start. The manufacturing capacity at the Tel Aviv facility is limited, and the company is still in the process of expanding its manufacturing footprint to the United States. The exosome program, while promising, is still in the preclinical stage and requires strategic partnerships to advance towards clinical development. Q: Can you start the trial without proper funding? A: Chaim Lebovits, President and CEO, stated that while significant progress has been made in preparing for the trial, initiating and executing it requires robust funding. They are actively pursuing multiple funding avenues, including a $15 million non-dilutive grant and strategic partnerships, to ensure the trial's commencement. Q: What is the significance of naming the trial ENDURANCE? A: Chaim Lebovits explained that the name ENDURANCE resonates with the ALS community, symbolizing the strength and resilience of individuals with ALS and their families. It also reflects Brainstorm's commitment to generating robust data for NurOwn's regulatory approval. Q: Will the company also be producing in the U.S.? A: Hartoun Hartounian, COO, confirmed that expanding manufacturing to the U.S. is a strategic objective. They plan to announce a letter of intent with a U.S.-based facility that has passed FDA inspection, which is crucial for future commercialization and supply chain security. Q: Can you update on any advances in the exosome program? A: Netta Blondheim-Shraga, SVP of R&D, shared that the exosome program is progressing well, showing potential in treating respiratory and inflammatory diseases. They are preparing a manuscript on its efficacy in a COPD model and are pursuing strategic partnerships for clinical development. Q: Have you discussed stratifying by UNC13A with the FDA for the Phase 3b trial? A: Ibrahim Dagher, CMO, noted that while the FDA has not approved any biomarker as a surrogate, the UNC13A findings are exploratory. The trial design under the SPA is agreed upon, but they will continue to explore genetic factors in post hoc analyses. Q: How does the hypoxic stress co-culture with neuron cells support NurOwn's mechanism of action? A: Netta Blondheim-Shraga explained that the enriched media from NurOwn cells showed a protective effect on cells under hypoxic conditions, restoring them to near-normal levels. This supports NurOwn's mechanism and was included in their IND. Q: What are the plans for clinical trial sites and patient enrollment? A: Chaim Lebovits mentioned plans to open approximately 15 clinical trial sites, with details on They aim to enroll 200 patients over two to three years, with the BLA filing contingent on significant results from the first part of the trial. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
18-05-2025
- Business
- Yahoo
Annexon Announces Presentations on the Clinical Advancement of Tanruprubart as the First Potential Targeted Therapy for Guillain-Barré Syndrome (GBS) at the 2025 PNS Meeting
First Oral Presentation by the International Guillain-Barré Syndrome Outcomes Study (IGOS) of the Real-World Evidence (RWE) Results Showing Improved Outcomes with Tanruprubart (formerly ANX005) Compared to Current Standards of Care in Matched Patient Populations New Analyses of Phase 3 Trial Highlight Tanruprubart's Early and Durable Treatment Effect and Improvement in Quality of Life in Patients with GBS BRISBANE, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting at the Edinburgh International Conference Centre being held May 17-20, 2025 in Edinburgh, UK. GBS is a neuromuscular emergency and rare autoimmune disease with no FDA-approved therapies that is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation. Tanruprubart is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade, with a single infusion to halt ongoing neuroinflammation and nerve damage in the acute phase of GBS to improve and expedite overall recovery. Oral Presentation 'Comparative Effectiveness in IGOS: ANX005 Versus Intravenous Immunoglobulin or Plasma Exchange for Guillain-Barré Syndrome' IGOS Presenter: Eveline Wiegers, M.D., Ph.D. Date/Time: Monday, May 19, from 3:55 pm to 4:10 pm British Summer Time (BST) Poster Presentations 'Linking Early Complement Inhibition to Long-Term Outcomes in GBS: Objective Measures Support Tanruprubart (ANX005) Efficacy' Presenter: Glenn Morrison, Ph.D. Date/Time: Sunday May 18, from 2:30 pm to 3:20 pm BST 'Tanruprubart (ANX005) Improves Health-related Quality of Life in Patients with Guillain-Barré Syndrome Compared to Placebo' Presenter: Glenn Morrison, Ph.D. Date/Time: Monday, May 19, from 2:10 pm to 3:10 pm BST. Poster also selected as a flash oral presentation from 5:30 pm to 5:35 pm BST. 'Efficacy of Tanruprubart (ANX005) for Treatment of Guillain-Barré Syndrome in a Broad Spectrum of Patients' Presenter: Henk-André Kroon, M.D. Date/Time: Monday May 19, from 2:10 pm to 3:10 pm BST About Tanruprubart (formerly ANX005)Annexon's lead investigational therapy, tanruprubart, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by stopping C1q activity in the peripheral and central nervous systems. In GBS, tanruprubart is designed to seek out C1q and prevent its binding to targets on peripheral nerves. Tanruprubart is administered intravenously and has been observed to act almost immediately in blocking C1q function. The aim of an effective treatment in GBS is to rapidly stop the autoimmune damage on nerve cells, allowing patients to regain muscle strength sooner and to regain independence and return to pre-illness activities. Tanruprubart has received both Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as orphan drug designation from the European Medicines Agency for the treatment of GBS. About Guillain-Barré Syndrome (GBS)GBS is a rare neuromuscular emergency resulting from an acute autoantibody and classical complement-mediated attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons. It is an acute, rapidly progressive disease with a narrow timeframe for therapeutic intervention. GBS results in the hospitalization of more than 22,000 people annually in the U.S. and Europe. The peripheral nerve damage progresses rapidly, causing acute neuromuscular paralysis that can lead to significant morbidity, disability and mortality. Currently, there are no approved treatments for GBS in the U.S. The long-term disease burden associated with GBS has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system alone. More information about the impact of GBS is available at About AnnexonAnnexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement's potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon's mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'design,' 'due,' 'estimate,' 'expect,' 'goal,' 'intend,' 'may,' 'objective,' 'plan,' 'positioned,' 'potential,' 'predict,' 'seek,' 'should,' 'suggest,' 'target,' 'on track,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, the ability of tanruprubart (formerly ANX005) to stop C1q activity in the peripheral and central nervous systems; the clinical and regulatory status of ANX005; and the potential therapeutic benefit of ANX005; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company's portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled 'Risk Factors' contained in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact:Joyce AllaireLifeSci Advisors, LLCjallaire@ Media Contact:Sheryl SeapyReal Chemistry949-903-4750sseapy@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
