RE: Up again25 Mar 2025 13:11
Tiziana Life Sciences Ltd.
NEW YORK, March 25, 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 dosing of new patients at Yale MS Center which is participating in our multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Other centers are currently enrolling include Johns Hopkins, U Mass Medical Center and Brigham and Women’s Hospital.
This Phase 2 trial aims to assess the safety, tolerability, and foralumab’s effect on microglial activation in patients with na-SPMS. Intranasal foralumab offers a novel approach to potentially mitigate the progression of SPMS. This multicenter study is important because it combines brain PET imaging, immunology, and measures of clinical evidence accepted by FDA.
"We are pleased to announce dosing at Yale in our multicenter Phase 2 trial, marking an important milestone in our efforts to address the unmet medical needs of patients with non-active SPMS," said William Clementi, PharmD, Chief Development Officer of Tiziana Life Sciences. "This trial represents a significant milestone in our clinical development program for intranasal foralumab and underscores our commitment to advancing innovative treatments and immune based approaches for autoimmune diseases."
The double blinded, multicenter placebo-controlled Phase 2 trial is expected to be completed by the end of 2025, with all participants, including those initially randomized to receive placebo during the blinded phase, having the opportunity to continue to participate in a further 6-month open-label extension (OLE) study. The OLE phase aims to further evaluate the long-term safety, tolerability, and durable effectiveness of foralumab in a larger number of patients.