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].

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].