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 and qualified news journalists who produce independent content [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 various 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 Viewpoint - Tiziana Life Sciences is advancing its Phase 2 clinical trial for intranasal foralumab, targeting non-active Secondary Progressive Multiple Sclerosis (na-SPMS), with new patient dosing initiated at Yale MS Center and other participating centers [1][2][3]. Group 1: Clinical Trial Details - The Phase 2 trial aims to evaluate the safety, tolerability, and effects of foralumab on microglial activation in na-SPMS patients [2]. - The trial is a double-blinded, multicenter placebo-controlled study expected to conclude by the end of 2025, with an opportunity for participants to engage in a 6-month open-label extension study [3]. - Currently, 10 patients have been dosed in an open-label Expanded Access Program, showing either improvement or stability of disease within 6 months [4]. Group 2: Drug Mechanism and Innovation - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, potentially mitigating inflammation in neuroinflammatory diseases [4][5]. - The nasal delivery method of foralumab is expected to enhance efficacy and safety compared to traditional intravenous delivery methods [6]. Group 3: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using advanced drug delivery technologies [6]. - The company is committed to addressing unmet medical needs in autoimmune diseases through its unique immunomodulatory approaches [3][6].

Core Viewpoint - Tiziana Life Sciences is actively participating in the 37th Annual ROTH Conference, showcasing its lead candidate, intranasal foralumab, which is a fully human anti-CD3 monoclonal antibody aimed at treating neuroinflammatory diseases [1][2]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies through alternative drug delivery technologies, particularly in immunotherapy [4]. - 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 [4]. Product Development - Foralumab has shown the ability to stimulate T regulatory cells when administered intranasally, with 10 patients suffering from Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) already dosed in an open-label Expanded Access Program, showing either improvement or stability of disease within 6 months [2]. - The FDA has approved the enrollment of an additional 20 patients in the Expanded Access Program for foralumab [2]. - A Phase 2a randomized, double-blind, placebo-controlled trial for intranasal foralumab in patients with non-active secondary progressive multiple sclerosis is currently underway [2][3]. Mechanism of Action - Foralumab binds to the T cell receptor, modulating T cell function and dampening inflammation, which is beneficial in treating conditions like COVID-19 and multiple sclerosis [3]. - The immunomodulation approach using nasal anti-CD3 monoclonal antibodies represents a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [3]. Conference Participation - The CEO of Tiziana Life Sciences, Ivor Elrifi, will present during a fireside chat at the ROTH Conference and will host 1x1 investor meetings, indicating the company's commitment to engaging with investors and stakeholders [1].

Core Viewpoint - Tiziana Life Sciences has regained compliance with Nasdaq's minimum bid price requirement, allowing its common stock to continue trading on the Nasdaq Capital Market [1][2]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using transformational drug delivery technologies, particularly through intranasal administration [5]. - 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 [5]. Product Development - Foralumab has been shown to stimulate T regulatory cells when administered intranasally, with positive outcomes observed in patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) [3]. - An open-label intermediate sized Expanded Access Program has dosed 10 patients, all of whom exhibited either improvement or stability of disease within six months [3]. - The FDA has approved the enrollment of an additional 20 patients in this program, and a Phase 2a trial is currently underway [3][4]. Mechanism of Action - Foralumab works by binding to the T cell receptor, modulating T cell function, and dampening inflammation, which is beneficial in treating conditions like COVID-19 and multiple sclerosis [4]. - The nasal administration of anti-CD3 monoclonal antibodies represents a novel approach for treating neuroinflammatory and neurodegenerative diseases [4].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The news team covers a wide range of sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive has a presence in key finance and investing hubs with bureaus and studios located in London, New York, Toronto, Vancouver, Sydney, and Perth [2] Group 2 - The company emphasizes the use of technology to enhance workflows, adopting automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [4][5]

Core Viewpoint - Tiziana Life Sciences has submitted an Investigational New Drug (IND) application to the FDA for a phase 2 clinical trial of intranasal foralumab in treating Amyotrophic Lateral Sclerosis (ALS), marking a significant advancement in the company's commitment to developing new treatment approaches for this disease [1][4]. Company Developments - The IND filing follows a grant awarded to Tiziana as part of the Hoffman ALS Clinical Trial Awards Program from the ALS Association, which supports the company's focus on three neurodegenerative diseases: ALS, Multiple Sclerosis, and Alzheimer's disease [2]. - Tiziana plans to initiate a 20-patient clinical trial to evaluate the safety and early-stage parameters of disease improvement in ALS upon FDA clearance of the IND application [4]. Product Information - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, showing potential in treating neurodegenerative diseases [5][6]. - The drug has been previously tested in patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS), with all 10 patients showing either improvement or stability of disease within six months [5]. Industry Context - ALS is a progressive neurodegenerative disease with limited treatment options, emphasizing the importance of advancing research efforts like those undertaken by Tiziana Life Sciences [3]. - Tiziana's innovative nasal delivery approach aims to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [7][8].

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's content includes insights across various sectors such as 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 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 has announced a significant study demonstrating that its intranasal anti-CD3 monoclonal antibody, foralumab, effectively reduces neuroinflammation and improves recovery in traumatic brain injury (TBI) models, indicating a promising therapeutic approach for TBI patients [1][3]. Group 1: Study Findings - The landmark study published in Nature Neuroscience shows that nasal administration of foralumab significantly reduces neuroinflammation and correlates with improved neurological outcomes, including reduced anxiety, cognitive decline, and enhanced motor skills in preclinical TBI models [1][2]. - The therapy induces IL-10 producing regulatory T cells (Tregs) that migrate to the brain, modulating microglia activity and reducing chronic inflammation, which is crucial for mitigating CNS damage and behavioral deficits associated with TBI [2][3]. - Blocking the IL-10 receptor negated the benefits of nasal anti-CD3 therapy, confirming IL-10's critical role in the therapeutic effect, while the adoptive transfer of IL-10 producing Tregs restored the benefits, validating the mechanism of action [3]. Group 2: Implications for Treatment - The positive results support advancing foralumab as a novel treatment for TBI, with potential applications in various settings, including hospitals and emergency situations [4]. - Tiziana's proprietary nasal anti-CD3 monoclonal antibody platform has shown potential in treating multiple neuroinflammatory and autoimmune diseases, reinforcing the commitment to develop transformative therapies for conditions like Multiple Sclerosis, Alzheimer's disease, and ALS [4][9]. - The company believes that nasal foralumab could be a game-changer in addressing the critical unmet medical need for effective TBI treatments [4][9]. Group 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, which may enhance efficacy and safety compared to traditional intravenous methods [9]. - Foralumab is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in ongoing studies [9].

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 and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including 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 Viewpoint - Tiziana Life Sciences is advancing its lead candidate, intranasal foralumab, as a potential treatment for long COVID by targeting microglial activation, which is linked to persistent brain inflammation and associated symptoms [1][2][5]. Group 1: Company Overview - Tiziana Life Sciences is a biotechnology company focused on developing innovative immunomodulation therapies, with intranasal foralumab being its lead candidate [1][8]. - The company utilizes a unique nasal delivery method for its therapies, which may enhance efficacy and safety compared to traditional intravenous methods [8]. Group 2: Product Development - Foralumab is a fully human anti-CD3 monoclonal antibody that has shown promise in reducing microglial activation in preclinical studies and has been well-tolerated in human trials [1][4][6]. - A previous clinical study demonstrated that intranasal foralumab significantly reduced lung inflammation in patients with mild to moderate COVID-19 [3]. - The company is currently conducting a Phase 2a trial for foralumab in patients with non-active secondary progressive multiple sclerosis, with positive early results reported [6][7]. Group 3: Long COVID Context - Long COVID affects millions globally, characterized by symptoms such as fatigue, cognitive impairment, and psychiatric issues, which are linked to sustained brain inflammation [2]. - The medical community recognizes the urgent need for targeted therapies to address the complexities of long COVID, making Tiziana's approach particularly relevant [5].