Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that a reduction in activated microglia, as seen in six-month Positron Emission Tomography (PET) scans, has now been observed in a total of five of the six patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal Foralumab in its Expanded Access Program (EAP).
The clinical-stage biopharmaceutical company said activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis (MS), Alzheimer’s disease, and amyotrophic lateral sclerosis, or ALS.
"I believe that the six-month qualitative na-SPMS PET readout by Dr Singhal is very encouraging and will enable us to rapidly advance Foralumab in Phase 2a testing to address patients afflicted with this devasting disease who currently have no FDA-approved treatments available," Tiziana Life Sciences acting CEO Gabriele Cerrone said in a statement.
Tiziana noted that Foralumab will advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody.
It added that Phase 2 trial screening for na-SPMS will begin in November 2023.
Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T-cell receptor and dampens inflammation by modulating T-cell function, thereby suppressing effector features in multiple immune cell subsets, according to the company.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy.
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