Tiziana Life Sciences Submits Seventh Annual Safety Update Report

Tiziana Life Sciences announces the submission of its seventh annual Development Safety Update Report to the U.S. Food and Drug Administration. This DSUR, reports no drug-related serious adverse events after a cumulative exposure of 37.4 patient-years, highlighting the safety and tolerability data profile of intranasal foralumab in treating neuroinflammatory diseases, including non-active secondary progressive multiple sclerosis, multiple system atrophy and Alzheimer's Disease. Key highlights from the submission include: Expanded Access Program: Fourteen naSPMS patients received nasal foralumab at 50 micrograms per dose for durations from 23 weeks to 3.5 years, contributing 30.7 patient-years of exposure. TILS-021 Randomized Trial and TILS-022 Open-Label Extension: In our naSPMS study and its extension, patients have received foralumab, for about 5.2 patient-years of exposure. Single-Patient Expanded Access for AD: One patient with moderate Alzheimer's Disease completed 28 weeks of treatment at 50 micrograms, adding 0.5 patient-years. This cumulative exposure of 37.4 patient-years underscores the significant clinical experience gained with intranasal foralumab in CNS indications. Notably, no serious adverse events have been attributed to the study drug in these nasal administration studies. Adverse events reported during the period were consistent in type and frequency with previous reports. No new risks were identified that necessitated significant protocol modifications. The safety profile of intranasal foralumab aligns with prior studies of foralumab administered intravenously in healthy volunteers, patients with Crohn's disease, and kidney transplant recipients. Unlike IV administration, which has been linked to infusion-related reactions seen with other anti-CD3 monoclonal antibodies, nasal delivery of foralumab has shown vastly improved tolerability, with no such issues observed. No new actions are required to address foralumab safety based on this update.