Tiziana Life Sciences (TLSA) Newsfilter·2025-03-25 12:00Core 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].