Tiziana Reveals Alzheimer's Research Milestone With PNAS Journal After FDA IND Green Light

Tiziana Life Sciences Ltd. TLSA recently announced a major milestone in Alzheimer's disease research with the acceptance of their publication, "Nasal Administration of anti-CD3 monoclonal antibody (mAb) ameliorates disease in a mouse model of Alzheimer’s disease," in the prestigious journal, Proceedings of the National Academy of Sciences (PNAS). This groundbreaking research further validates foralumab's potential as a revolutionary treatment for Alzheimer's disease, a challenging neuroinflammatory condition. Notably, this marks the second publication this year in PNAS related to intranasal anti-CD3 monoclonal antibody administration.

The study demonstrates that intranasal anti-CD3 effectively mitigates Alzheimer's disease in a rodent model by targeting microglial activation in the brain and influencing brain gene expression, all while remaining independent of amyloid beta deposition. These findings open up an exciting new avenue for treating Alzheimer's disease, offering fresh hope for patients.

You can access the publication here.

Dr. Howard L. Weiner, a distinguished expert in neurology at Harvard Medical School and Chairman of Tiziana's Scientific Advisory Board, expressed his pride as the senior author of this seminal publication. He highlighted the uniqueness of the mechanism of action that separates this approach from traditional treatments, emphasizing the potential foralumab holds in modulating microglia through T-cell induction, a concept that can now be tested in humans following recent FDA IND clearance.

Gabriele Cerrone, Executive Chairman, founder, and acting Chief Executive Officer of Tiziana, shared his enthusiasm for the groundbreaking research conducted in collaboration with Brigham and Women’s Hospital, led by Dr. Weiner. He emphasized that this latest publication, alongside ongoing research, expands the possibilities for foralumab in addressing multiple neuroinflammatory diseases, including non-active secondary progressive multiple sclerosis.

Study Rationale: Alzheimer's disease, characterized by Aβ plaques, neurofibrillary tangles, and microglial activation, features significant neuroinflammation. Microglia, the brain's primary immune cells, play a pivotal role in maintaining homeostasis and responding to injury. Emerging evidence suggests inflammatory pathways are heavily involved in Alzheimer's disease. While Aβ-targeted therapies have shown promise, nasal anti-CD3 has exhibited its potential in addressing microglial inflammation in the brain, as demonstrated in a model for multiple sclerosis.

Study Design: The study administered intranasal anti-CD3 to mice three times a week for five months, comparing the results against isotype control or saline-treated mice. In the treated group, researchers observed a modulation of the activated microglia phenotype, altered gene expression patterns in the brain, and improved cognitive functions. Remarkably, these positive effects occurred independently of amyloid beta deposition. Microglia modulation was assessed through specific markers and gene expression analysis, with cognition measured through various behavioral tests. Amyloid beta accumulation was evaluated in specific brain regions.

Tiziana Life Sciences is pioneering a new frontier in Alzheimer's research, offering renewed hope for patients and the potential to revolutionize treatment approaches for this challenging neuroinflammatory disease.

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