Tiziana Life Sciences Announces Updated Clinical and PET Scan Findings for Intranasal Foralumab in Two New Multiple Sclerosis Patients

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced positive findings have been seen in a total of six out of eight Intermediate Size Patient Population Expanded Access (EA) patients. These patients have shown improvements in fatigue scores measured by the Modified Fatigue Impact Scale (MFIS). PET scan findings showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation period. PET scan findings for two additional EA patients (10 total) are planned to be available in late January.

Tarun Singhal, M.B.B.S., M.D., Director of PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, commented, “Upon review of the baseline and three-month [F-18] PBR06 PET scans of the two new na-SPMS EA patients, a qualitative reduction in microglial activity was seen in one of two new patients. When combined with my assessment of the first six EA patients at three-months, a total of six out of the eight suggested a reduction in qualitative microglial PET signal. These findings are promising from an imaging standpoint and further studies are needed to confirm them using additional quantitative approaches.”

“The EA patient having a qualitative improvement in their PET scan also improved in their Modified Fatigue Impact Scale,” stated Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital. “Six out of the eight na-SPMS EA patients studied so far have seen measurable clinical improvement in their fatigue. I am excited to lead the effort to replicate these findings in the ongoing Phase 2 dose-ranging, randomized, placebo-controlled clinical trial.”

Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences noted “We’ve seen continued clinical and qualitative PET scan improvement over time in patients with na-SPMS where intranasal foralumab targets inflammation in the brain. It is my expectation that we will rapidly progress our ongoing Phase 2 trial of intranasal foralumab, given the encouraging results seen so far under the EA IND."