Core Viewpoint - Tiziana Life Sciences is advancing its investigational drug, intranasal foralumab, for moderate Alzheimer's disease, which currently lacks effective treatment options, as highlighted in a recent news segment featuring a patient from the company's expanded access program [1][2]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [8][9]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody in clinical development, demonstrating a favorable safety profile and clinical response in prior studies [9]. Drug Mechanism and Efficacy - Foralumab targets immune system dysregulation associated with Alzheimer's disease, potentially slowing disease progression and improving cognitive function by modulating inflammation linked to neurodegeneration [3][5]. - The drug has shown efficacy in reducing microglial activation and inducing T regulatory cells, which help modulate neuroinflammation, validated in animal models and patients with secondary progressive multiple sclerosis [5][7]. Expanded Access Program - The expanded access program allows patients without access to clinical trials to receive intranasal foralumab as part of a compassionate use initiative, with initial results showing improvement or stability in disease for all 10 patients dosed [6]. Clinical Trials - Tiziana is conducting a Phase 2a, randomized, double-blind, placebo-controlled trial for intranasal foralumab in patients with non-active secondary progressive multiple sclerosis, which began screening patients in November 2023 [7][6].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - Tiziana Life Sciences is advancing its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, showing promising results in treating traumatic spinal cord injury (SCI) through modulation of microglial inflammation [1][4][5]. Group 1: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal routes for immunotherapy [8]. - The lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in prior studies [8]. Group 2: Research Findings - Preclinical studies indicate that treatment with nasal anti-CD3 significantly improves motor functions in models of spinal cord injury by dampening microglial activation [2][5]. - Approximately 300,000 individuals in the U.S. are living with spinal cord injuries, with over 17,000 new cases reported annually, highlighting the urgent need for effective treatments [3]. Group 3: Scientific Insights - The inflammatory response mediated by microglia is crucial in the pathogenesis of spinal cord injuries, and nasal anti-CD3 plays a pivotal role in modulating this inflammation [2][4]. - Foralumab stimulates T regulatory cells when administered intranasally, which may lead to reduced inflammation and improved outcomes in neuroinflammatory conditions [6][7].

Core Insights - Tiziana Life Sciences has announced its intention not to engage in capital raising activities for the immediate future, following the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis treated with nasal foralumab [1][2] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough therapies using innovative drug delivery technologies, particularly through nasal administration [3] - The lead candidate, intranasal foralumab, is a fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in previous studies [3] - The company's nasal approach aims to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [3] Commitment to Shareholders - The management team of Tiziana Life Sciences remains dedicated to delivering value to shareholders while advancing its innovative drug candidates through clinical trials and regulatory processes [2]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with nasal foralumab. We believe these findings contribute substantially t ...

NEW YORK, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced findings on the prolonged benefits of its nasal anti-CD3 monoclonal antibody in sustaining tissue homeostasis and mitigating the side effects associated with GLP-1 agonists discontinuation. This advan ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

NEW YORK, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that a review article titled "Immune mechanisms and shared immune targets in neurodegenerative diseases" was published in Nature Reviews Neurology, highlighting the therapeutic potential of intranasal ...

Core Article Summary - The article highlights the therapeutic potential of intranasal Foralumab, a fully human anti-CD3 monoclonal antibody, for treating neurodegenerative diseases such as Multiple Sclerosis (MS), Alzheimer’s disease, ALS, and Parkinson’s disease [1][8] - Foralumab works by dampening microglial activation, a key driver of disease in these neurological conditions, and has shown no apparent side effects with easy administration [1] - The review article emphasizes the role of the immune system in neurodegenerative diseases, with microglia being a common therapeutic target [4][9] Clinical Development and Trials - Foralumab is currently being studied in a Phase 2a trial for non-active secondary progressive multiple sclerosis (NCT06292923), with 10 patients already dosed in an Expanded Access Program showing improvement or stability within 6 months [5] - The FDA has allowed an additional 20 patients to be enrolled in the Expanded Access Program [5] - The Phase 2 trial for non-active SPMS began screening patients in November 2023 [2] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative immunomodulation therapies using alternative drug delivery technologies, such as intranasal administration [6] - The company’s lead candidate, intranasal Foralumab, is the only fully human anti-CD3 monoclonal antibody in clinical development and has demonstrated a favorable safety profile and clinical response in studies [6] - Tiziana’s technology for alternative routes of immunotherapy has been patented, with several applications pending, enabling broad pipeline applications [6] Scientific Insights - The review article discusses how microglia, monocytes, and T cells contribute to the pathogenesis of neurodegenerative diseases and their potential as shared therapeutic targets [9] - The microbiome is highlighted as an emerging therapeutic target that indirectly modulates the immune system [9] - Foralumab modulates T cell function by binding to the T cell receptor, dampening inflammation and suppressing effector features in immune cells [10] Industry Implications - Immunotherapeutic approaches targeting the adaptive and innate immune systems are being explored for the treatment of neurological diseases, with common targets and approaches across diseases [4] - The intranasal delivery of Foralumab represents a promising therapeutic avenue for patients with limited treatment options, particularly in progressive MS and other neurological diseases [1][6]