Tiziana Life Sciences Expands Phase 2 Trial for Foralumab, Adds Weill Cornell Multiple Sclerosis Center

Tiziana Life Sciences has expanded its Phase 2 trial for intranasal foralumab to a fifth site at Weill Cornell Medicine Multiple Sclerosis Center. The trial aims to evaluate the safety and efficacy of the novel treatment for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Patient dosing has commenced, and the study design includes a blinded phase followed by a six-month open-label extension phase. This expansion is a significant development in the company's research into treatments for na-SPMS.

Title: Tiziana Life Sciences Expands Phase 2 Trial for Intranasal Foralumab

New York, June 14, 2025 — Tiziana Life Sciences Ltd. (Nasdaq: TLSA) has expanded its Phase 2 clinical trial for intranasal foralumab to include the Weill Cornell Medicine Multiple Sclerosis Center. The trial, which aims to evaluate the safety and efficacy of foralumab in treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS), has now commenced patient dosing at the esteemed center in New York City.

The expansion marks the fifth site participating in the trial, following previous sites at Yale University, Johns Hopkins University, Brigham and Women's Hospital, and the University of Massachusetts. The addition of Weill Cornell Medicine, renowned for its expertise in MS research and patient care, further strengthens the clinical trial's scientific rigor and recruitment capabilities [1].

The trial design includes a blinded phase followed by a six-month open-label extension phase. This structure allows all participants, including those initially receiving a placebo, to access foralumab, thereby enhancing the collection of long-term safety and efficacy data. The extension phase is crucial for addressing the unmet medical needs within the MS treatment landscape [2].

Foralumab is the first fully human anti-CD3 monoclonal antibody administered via the intranasal route, representing a novel approach to engage regulatory T cells and promote immune tolerance while minimizing systemic immune suppression. The unique intranasal application of foralumab is a critical advancement over traditional systemic therapies [3].

Tiziana Life Sciences CEO Ivor Elrifi commented, "The addition of this esteemed site further strengthens our Phase 2 clinical trial, which aims to address the significant unmet medical need in MS treatment. We look forward to collaborating closely with the team at Weill Cornell and our other esteemed clinical partners as we progress toward potentially transformative outcomes for patients" [4].

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.

References

[1] 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
[2] 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
[3] https://www.marketwatch.com/story/tiziana-life-sciences-shares-up-after-expanding-multiple-sclerosis-trial-09ff8bce
[4] https://www.proactiveinvestors.com/companies/news/1072967/tiziana-life-sciences-expands-phase-2-ms-trial-to-fifth-site-commences-patient-dosing-1072967.html