Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - 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 operates from key finance and investing hubs, including London, New York, Toronto, Vancouver, Sydney, and Perth [2][3] Group 2 - Proactive employs technology to enhance workflows and has a forward-looking approach to technology adoption [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business output a ...

Core Insights - Tiziana Life Sciences announced promising results from an open-label clinical study of intranasal foralumab for treating non-active secondary progressive multiple sclerosis (na-SPMS), demonstrating safety, regulatory immune response induction, and clinical progression stabilization [1][3][6] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal foralumab, the only fully human anti-CD3 monoclonal antibody in clinical development [10][9] Study Findings - The study showed that nasal foralumab was safe, reduced microglial activation, and stabilized clinical progression in patients with na-SPMS, addressing a significant unmet need in MS treatment [1][4][6] - All ten patients treated for a minimum of six months experienced stabilization of Expanded Disability Status Scale (EDSS) scores, with some showing improvement [7][6] - Significant reductions in microglial activation were observed at six months, with a p-value of less than 0.05 [6][7] Future Developments - Tiziana Life Sciences has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial to further evaluate the efficacy and safety of nasal foralumab, with top-line data expected by the end of 2025 [5][8] - The company is also exploring the potential of nasal foralumab in treating other conditions such as Alzheimer's Disease and ALS [8]

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 Insights - Tiziana Life Sciences has commenced dosing at the fourth clinical site for its Phase 2 trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS) [1][2][3] - The trial is a blinded, placebo-controlled study expected to conclude by the end of 2025, followed by a six-month open-label extension phase for all participants [2][4] - Foralumab is the first fully human anti-CD3 monoclonal antibody administered intranasally, designed to promote immune tolerance while minimizing systemic immune suppression [3][5] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies [5] - The company’s lead candidate, intranasal foralumab, has shown a favorable safety profile and clinical response in previous studies [5] - Tiziana's approach aims to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [5] Clinical Development - The Phase 2 trial began screening patients in November 2023, with the addition of the University of Massachusetts as a clinical site [1][5] - Initial results from an open-label Expanded Access Program indicated that all 10 patients with na-SPMS experienced either improvement or stability of disease within six months [4] - The trial's design includes a focus on long-term safety and sustained benefits of foralumab in the na-SPMS patient population [2][4]

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 adopts technology enthusiastically, utilizing decades of expertise and experience among its content creators [4] - The company employs 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 Phase 2 trial of intranasal foralumab for treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS), with dosing now initiated at Johns Hopkins University, marking a significant milestone in the company's clinical development efforts [1][3]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized, double-blind, and placebo-controlled, focusing on the safety, tolerability, and efficacy of intranasal foralumab in na-SPMS patients, a form of multiple sclerosis characterized by progressive neurological decline without relapses [2][3]. - The trial includes multiple clinical sites, with Johns Hopkins University being the third site added, alongside Brigham and Women's Hospital and MS Center at Yale Medical Center [1][3]. - The blinded portion of the trial is expected to be completed by the end of 2025, followed by a six-month open-label extension period for all participants [3]. Group 2: Drug Candidate Information - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, representing a novel approach to treating neuroinflammatory and neurodegenerative diseases [4][5]. - In an open-label intermediate-sized Expanded Access Program, 10 patients with na-SPMS have shown either improvement or stability of disease within six months [4]. - Foralumab is currently the only fully human anti-CD3 monoclonal antibody in clinical development, with its Phase 2 trial having begun patient screening in November 2023 [5]. Group 3: Company Commitment and Innovation - Tiziana Life Sciences emphasizes its commitment to innovation in treating neurodegenerative diseases, reinforced by the expansion of the trial to a major clinical site [4]. - The company believes that intranasal foralumab could represent a paradigm shift in addressing non-active Secondary Progressive MS, aiming to provide new hope for patients [4][6]. - Tiziana's innovative nasal drug delivery technology is expected to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6].

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].