Tiziana Life Sciences Expands Phase 2 MS Trial, Initiates Patient Dosing at Fifth Site

Tiziana Life Sciences has expanded its Phase 2 MS trial to five sites, including Weill Cornell Medicine in New York City, to evaluate the safety and efficacy of intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis. Patient dosing has commenced at Weill Cornell, with the trial aiming to address the significant unmet medical need in MS treatment. The company plans to assess long-term safety and potential sustained benefits of foralumab in a six-month open-label extension phase.

Tiziana Life Sciences (TLSA) has announced the expansion of its Phase 2 clinical trial for intranasal foralumab to include Weill Cornell Medicine Multiple Sclerosis Center in New York City. This addition marks the fifth site in the trial, which aims to evaluate the safety and efficacy of the treatment in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) [1][2][3].

The trial, which commenced patient dosing at Weill Cornell, will now be conducted at five prestigious sites: Yale University, Johns Hopkins University, Brigham and Women's Hospital, the University of Massachusetts, and Weill Cornell Medicine. This expansion is designed to enhance the study's reach and capacity, facilitating a more comprehensive evaluation of foralumab's potential benefits [1][3].

Intranasal foralumab, Tiziana's lead development candidate, is a fully human anti-CD3 monoclonal antibody. The unique intranasal delivery method engages regulatory T cells and promotes immune tolerance while minimizing systemic immune suppression. This novel approach represents a significant advancement over traditional systemic therapies [1][2].

The trial is structured with a blinded phase followed by a six-month open-label extension phase. This design allows all participants, including those who initially received a placebo, to access foralumab. The open-label extension phase is crucial for assessing long-term safety and sustained benefits of the treatment [1][2].

Weill Cornell Medicine's inclusion in the trial is particularly noteworthy due to its renowned expertise in MS research and patient care. The center's involvement is expected to contribute significantly to the trial's scientific rigor and enhance recruitment capabilities [1][3].

The expansion of this clinical program signals a promising step forward for Tiziana Life Sciences as it continues to develop innovative therapies targeting neuroinflammatory and neurodegenerative diseases. The company is committed to addressing the significant unmet medical need in MS treatment and looks forward to collaborating with esteemed clinical partners to achieve potentially transformative outcomes for patients [1][2][3].

References:
[1] https://www.gurufocus.com/news/2926424/tiziana-life-sciences-expands-phase-2-clinical-trial-of-intranasal-foralumab-with-commencement-of-first-patient-dosing-at-weill-cornell-multiple-sclerosis-center-tlsa-stock-news
[2] https://www.globenewswire.com/news-release/2025/06/13/3099102/0/en/Tiziana-Life-Sciences-Expands-Phase-2-Clinical-Trial-of-Intranasal-Foralumab-with-Commencement-of-First-Patient-Dosing-at-Weill-Cornell-Multiple-Sclerosis-Center.html
[3] https://www.proactiveinvestors.com/companies/news/1072967/tiziana-expands-phase-2-ms-trial-to-fifth-site-commences-patient-dosing-1072967.html