About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

NEW YORK, July 21, 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 compelling immunologic findings from the treatment of a moderate Alzheimer's Disease (AD) patient with intranasal foralumab. Transcriptional analysis of white blood cells before and after foralumab th ...

Group 1 - The article discusses Tiziana Life Sciences (NASDAQ: TLSA) and its ongoing drug development efforts, particularly focusing on the Foralumab drug and its additional Expanded Access Program (EAP) enrollment [2] - The author is affiliated with Biotech Analysis Central, which provides extensive analysis and resources for healthcare investors, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2] - The service offered by Biotech Analysis Central is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1] Group 2 - The article does not provide specific financial data or performance metrics related to Tiziana Life Sciences or its products [4] - There are no disclosed positions or plans to initiate positions in the companies mentioned, indicating a neutral stance from the author [3]

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Core Viewpoint - Tiziana Life Sciences has commenced dosing in a Phase 2 clinical trial for intranasal foralumab, targeting non-active Secondary Progressive Multiple Sclerosis (na-SPMS) at Weill Cornell Medicine, expanding its research efforts in this area [1][2][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [7]. - The company’s 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 [7][6]. Clinical Trial Details - The Phase 2 trial aims to evaluate the safety and efficacy of intranasal foralumab in treating multiple sclerosis, a chronic autoimmune disease affecting the central nervous system [2]. - The trial includes multiple prestigious sites, with Weill Cornell Medicine being the latest addition, enhancing the collaborative effort in MS research [1][2][3]. - Following the blinded phase, all participants will have the opportunity to receive intranasal foralumab during a six-month open-label extension phase to assess long-term safety and sustained benefits [3]. Product Information - Foralumab is designed to engage regulatory T cells through a non-systemic approach, promoting immune tolerance while minimizing systemic immune suppression [4]. - Initial results from an open-label Expanded Access Program indicated that 10 patients with na-SPMS experienced either improvement or stability of disease within six months [5]. Industry Context - The development of intranasal foralumab represents a novel approach in the treatment of neuroinflammatory and neurodegenerative diseases, positioning Tiziana Life Sciences at the forefront of innovative therapies in this field [6].

Core Insights - Tiziana Life Sciences is developing intranasal foralumab, a fully human anti-CD3 monoclonal antibody, aimed at treating neuroinflammatory and neurodegenerative diseases [1][3][4] - The company is conducting a Phase 2 trial for non-active Secondary Progressive Multiple Sclerosis (na-SPMS) and plans to initiate a Phase 2 trial for early Alzheimer's Disease [1][2] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on innovative drug delivery technologies for immunotherapy [4] - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response [4] Clinical Development - The Phase 2 trial for intranasal foralumab in na-SPMS began patient screening in November 2023, with positive outcomes reported in an open-label program involving 10 patients [2][3] - The drug is designed to stimulate T regulatory cells through intranasal administration, promoting immune tolerance while minimizing systemic immune suppression [1][2]

Core Insights - Tiziana Life Sciences has made advancements in treating moderate Alzheimer's disease with its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, which targets brain inflammation [1][2][4] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [6] - The company’s lead candidate, foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in previous studies [5][6] Clinical Developments - The first patient treated with intranasal foralumab, Joe Walsh, showed significant reduction in brain inflammation, indicating a promising step forward in Alzheimer's treatment [2][3] - Foralumab is also being studied in a Phase 2a trial for patients with non-active secondary progressive multiple sclerosis, with positive outcomes observed in an open-label program [4][5] Treatment Mechanism - Foralumab works by stimulating T regulatory cells through intranasal dosing, which helps mitigate inflammation in the brain, a critical factor in the progression of Alzheimer's disease [4][5]

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Core Insights - Tiziana Life Sciences announced a study demonstrating that intranasal foralumab significantly reduced microglial activation in a 78-year-old patient with moderate Alzheimer's disease, indicating a potential new treatment avenue for neurological disorders [1][2][7] Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing immunomodulation therapies, with its lead candidate being intranasal foralumab, a fully human anti-CD3 monoclonal antibody [1][12] - The company aims to provide alternative routes of immunotherapy, which may enhance efficacy and safety compared to traditional intravenous delivery methods [12] Study Findings - The study published in the Journal of Clinical Nuclear Medicine utilized advanced PET imaging to assess microglial activation before and after treatment, revealing a notable reduction in neuroinflammation following intranasal foralumab administration [2][5] - This case marks the first use of 18F-PBR06-PET in a patient with moderate Alzheimer's disease and the first report of an Alzheimer's patient treated with nasal-foralumab [2][8] Future Directions - Tiziana Life Sciences plans to initiate a phase-2a study of nasal-foralumab in mild Alzheimer's disease, addressing the unmet need for disease-modifying therapies in this area [8][10] - The company has previously reported similar effects of nasal-foralumab in reducing microglial activation in patients with non-active secondary progressive multiple sclerosis [8][10]

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