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Tiziana Life Sciences, a biotechnology company developing innovative immunomodulatory therapies, has announced the expansion of its Phase 2 clinical trial to evaluate the Intranasal foralumab in the treatment of non-active secondary progressive multiple sclerosis (SPMS). This trial will now include prestigious medical institutions in the Northeast of the USA.
New test sites
New trial sites include the following universities recognized for their leadership in medical and neurology research:
- Yale University
- Johns Hopkins University
- Cornell University
- University at Buffalo (SUNY)
- University of Massachusetts (UMass)
- Thomas Jefferson University
These centers will contribute their advanced facilities and expertise to evaluate the potential of intranasal foralumab. The decision to concentrate participants in the Northeast region seeks to standardize positron emission tomography (PET) scans at a single imaging center, Invicro, located in New Haven, Connecticut, reducing variability in results.
The urgent need for a treatment for SPMS
Non-active SPMS is a form of multiple sclerosis that severely affects quality of life and lacks FDA-approved treatments.Foralumab, a fully human anti-CD3 monoclonal antibody, offers a novel approach: it modulates the immune system and controls inflammation without systemically suppressing immunity. This represents a potential solution for a disease that continues to be a significant challenge in the medical community.
Clinical advances
The phase 2 trial aims to Collect robust data to support future regulatory applicationsTo date, 10 patients have been treated through an expanded access program and have shown improvement or stability over a 6-month period. The FDA has authorized the inclusion of 20 additional patients in this program.
About foralumab
Foralumab is the only fully human anti-CD3 monoclonal antibody. Administered intranasally, it stimulates regulatory T cells, which play a key role in inflammation. This innovative approach has been shown to reduce inflammation by modulating T cell function in a variety of inflammatory and neurodegenerative diseases, including multiple sclerosis and COVID-19.
