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]

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases. NEW YORK, May 12, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing bre ...

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Core Insights - Tiziana Life Sciences announced significant results from a PET scan showing a marked reduction in microglia activation in a patient with moderate Alzheimer's disease after three months of treatment with intranasal foralumab, indicating potential efficacy in reducing neuroinflammation associated with the disease [1][5][7] Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing innovative immunomodulation therapies, with its lead candidate being intranasal foralumab, a fully human anti-CD3 monoclonal antibody [1][9] - The company aims to address the urgent need for effective treatments for Alzheimer's disease, particularly in moderate stages, as current approved therapies are lacking [7][9] Treatment Mechanism - Intranasal foralumab works by inducing T regulatory cells (Tregs) that travel to the brain to reduce neuroinflammation, which has been confirmed in both animal models and patients with secondary progressive multiple sclerosis [6][9] - The treatment has shown a favorable safety profile and clinical response in ongoing studies, with all 10 patients in an open-label program experiencing either improvement or stability of their condition within six months [8][9] Research and Development - The findings were presented at the 2025 AD/PD Conference and highlight the need for further studies to explore the effects of foralumab in a broader patient population with moderate Alzheimer's disease [5][7] - Tiziana's innovative nasal delivery approach is expected to enhance the efficacy and safety of immunotherapy compared to traditional intravenous methods [9] Market Context - Alzheimer's disease currently affects over 50 million people worldwide, with projections indicating that this number could triple by 2050, underscoring the critical demand for new treatment options [7][9]