Figure 1

• Five out of six patients in FDA authorized Expanded Access Program are showing a qualitative reduction in microglia activation (a key biomarker being observed)

• Foralumab to advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody

• Phase 2 trial screening for na-SPMS to begin in November 2023
  

NEW YORK, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today 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). Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis, or ALS.

Tarun Singhal, M.B.B.S., M.D., Director of the PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Assistant Professor of Neurology at Harvard Medical School, commented, “Upon review of the baseline and six-month PET scans of the latest cohort of four Expanded Access patients, three out of the four scans suggested a qualitative reduction in the microglial PET signal. When combined with my assessment of the first two Expanded Access patients at six-months, five of the six suggested a reduction in qualitative microglial PET signal. An example of this can be seen in the graphic below, titled, “Figure 1”, showing the deactivation of this signal in patient EA6. This is promising from an imaging standpoint, and further studies are needed to confirm these findings using additional quantitative approaches."

Howard L. Weiner, M.D., Chairman of Tiziana's Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital added, “With six patients now dosed in our na-SPMS EA program, I feel that Dr. Singhal’s readout of the six-month PET scans strongly supports our previously announced 3-month clinical findings.”

Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “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.”