Tiziana Life Sciences Announces Additional Clinical Improvements Among Multiple Sclerosis Patients in its Expanded Access Program

• 70% of Patients in the Expanded Access Program (EAP) Have Seen Measurable Clinical Improvement in Their Fatigue After Six Months of Follow-up
• All Patients Have Either Stabilized or Improved on Nasal Foralumab Treatment and No Patients Declined in Key Clinical Measures

NEW YORK, April 22, 2024 (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 additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients. The data demonstrate multiple improvements in foralumab-treated patients, with 70% showing an improvement in fatigue after six months of follow-up. Fatigue is a debilitating symptom for many MS patients and is measured by the Modified Fatigue Impact Scale (MFIS).

“All patients in this na-SPMS study had previously clinically progressed on ocrelizumab. They subsequently were enrolled in our EA program and received 6-months of intranasal foralumab,” 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, a founding member of Mass General Brigham Healthcare System. “All 10 foralumab-treated patients stabilized or improved in key clinical measures, and seven showed clinical meaningful improvement in their fatigue at six months as measured by the MFIS. Other key clinical outcome measures included the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk Test (T25WT) and Pyramidal Scores in a disease state that typically shows a decline in function over time.   I am pleased to see the continued clinical response to intranasal foralumab from patients enrolled in our expanded access na-SPMS program.”

Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, commented “Fatigue is a pervasive and challenging symptom for individuals living with MS, impacting their daily lives in profound ways. The clinically meaningful improvement in fatigue levels seen in seven out of ten patients, as well as the stabilization or improvements in other key clinical outcome measures that were seen in all patients, underscores the potential of Tiziana's investigational therapy to address this critical unmet need.”