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Core Viewpoint - Tiziana Life Sciences has received a research grant from the U.S. Department of Defense to study intranasal anti-CD3 therapy for traumatic spinal cord injury, expanding its therapeutic potential into significant neurological conditions [1][2][3]. Group 1: Research and Development - The DoD grant will fund a three-year study focusing on the acute phase of spinal cord injury, targeting patients who arrive at the hospital immediately after injury [2]. - A complementary two-year Stepping Strong Breakthrough Award will investigate the chronic phase of spinal cord injury, concentrating on patients with ongoing neurological deficits [2]. - Tiziana's lead candidate, intranasal foralumab, is a fully human anti-CD3 monoclonal antibody that has shown promise in stimulating T regulatory cells and improving disease stability in patients with non-active secondary progressive multiple sclerosis [6][7]. Group 2: Market Opportunity - Traumatic spinal cord injury affects nearly 300,000 Americans with permanent disabilities and sees over 17,000 new injuries each year, representing a significant unmet medical need [3]. - Current treatments are primarily supportive, with no approved therapies that enhance neurological recovery or prevent chronic complications from spinal cord inflammation, indicating a substantial commercial opportunity for Tiziana [3]. Group 3: Mechanism and Benefits - Intranasal anti-CD3 therapy aims to rebalance the immune system, reduce inflammation in the injured spinal cord, and support functional recovery, potentially benefiting other acute central nervous system injuries [4][5]. - Preclinical results have indicated that this non-invasive therapy could improve motor outcomes, enhancing independence and quality of life for patients [4].

BOSTON, Sept. 09, 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 its Chief Executive Officer, Ivor Elrifi, has purchased 193,848 shares of Tiziana common stock at a price of $1.65 per share in the open market. About Foralumab Foralumab, a fully human anti-CD3 m ...

Core Insights - Tiziana Life Sciences has initiated a Phase 2a clinical trial for intranasal foralumab in patients with Multiple System Atrophy (MSA), marking a significant step in developing therapies for this rare neurodegenerative disorder [1][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly through nasal administration [9]. - 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 [9][7]. Clinical Trial Details - The Phase 2a trial will evaluate the efficacy of foralumab in reducing neuroinflammation and aims to determine its potential to slow disease progression and improve quality of life for MSA patients [3][4]. - The trial involves a six-month open-label study with participants receiving treatment over eight dosing cycles [3]. Disease Context - Multiple System Atrophy is a rare and rapidly progressive neurodegenerative disorder affecting an estimated 15,000–50,000 individuals in the U.S., with no FDA-approved treatments available to alter its course [2][5]. - The disease leads to severe movement, balance, and autonomic function issues, with most patients surviving only 6–9 years post-diagnosis [5]. Mechanism of Action - Foralumab works by stimulating T regulatory cells through a novel, non-systemic delivery approach, targeting the immune processes that may drive neurodegeneration [4][6]. - Early studies have indicated potential benefits of foralumab in stabilizing or improving function in other neuroinflammatory conditions, such as multiple sclerosis [4][6].

Proactive financial news and online broadcast teams provide fast, accessible, informative and actionable business and finance news content to a global investment audience. All our content is produced independently by our experienced and qualified teams of news journalists. Proactive news team spans the world's key finance and investing hubs with bureaus and studios in London, New York, Toronto, Vancouver, Sydney and Perth. About this content About Emily Jarvie Emily began her career as a political journalis ...

Core Viewpoint - Tiziana Life Sciences has received FDA approval for the IND of its Phase 2a clinical trial of intranasal foralumab for treating Multiple System Atrophy (MSA), addressing an unmet medical need in this orphan disease [1][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][7]. - 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 in previous studies [6][7]. Clinical Trial Details - The Phase 2a study is a six-month, open-label trial aimed at evaluating the effects of intranasal foralumab on microglial activation, clinical outcomes, and safety in MSA patients [2]. - Foralumab is administered via nasal spray in eight 3-week dosing cycles, targeting T-cell mediated neuroinflammation [2]. Disease Context - Multiple System Atrophy is a rapidly progressive neurodegenerative disorder with a mean incidence of 0.6 per 100,000 person-years in the US, increasing to 3 per 100,000 for individuals aged 50 and older [3]. - The disease leads to severe disability and has a poor prognosis, with a median survival of 6-9 years [3]. Mechanism of Action - Foralumab induces regulatory T cells and modulates T-cell-driven inflammation, potentially slowing neuronal damage in neuroinflammatory and degenerative diseases [4]. - The therapy aims to impact microglial activity and clinical outcomes significantly over the trial period [4].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - Tiziana Life Sciences announced significant immunologic findings from the treatment of a moderate Alzheimer's Disease patient with intranasal foralumab, indicating its potential as a breakthrough therapy [1][5] Immunologic Findings - Transcriptional analysis of white blood cells before and after foralumab therapy showed profound immune modulatory effects, with significant changes in CD4 cells, CD8 cells, and monocytes, linking immune effects to reduced brain inflammation [2] - An unexpected increase in phagocytosis markers in classical monocytes suggests that nasal foralumab may enhance the clearance of amyloid plaques, potentially opening new treatment avenues for Alzheimer's Disease [3] Expert Commentary - Dr. Howard Weiner highlighted the promising reduction in microglial inflammation and unique immune changes observed in the treated Alzheimer's patient, indicating a step forward in understanding foralumab's therapeutic role in neuroinflammatory diseases [4] - Ivor Elrifi, CEO of Tiziana, emphasized the dual benefits of nasal foralumab in reducing brain inflammation and influencing amyloid pathology, with the treatment being well tolerated and continued by the patient [4] Company Commitment - The findings represent a significant milestone in developing novel therapies for Alzheimer's Disease, underscoring Tiziana Life Sciences' commitment to advancing transformative treatments for neurodegenerative disorders [5] About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when dosed intranasally, with ongoing studies showing improvements or stability in patients with Non-Active Secondary Progressive Multiple Sclerosis [6][7] - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel approach for treating neuroinflammatory and neurodegenerative diseases [7] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing breakthrough therapies using innovative drug delivery technologies, with intranasal foralumab demonstrating a favorable safety profile and clinical response in studies [8][9]

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]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is a forward-looking company that adopts technology enthusiastically, utilizing decades of expertise and experience [4] - The company employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]