Tiziana Life announces FDA allowance for more patients to na-SPMS EA program

Tiziana Life Sciences announced that the U.S. Food and Drug Administration, FDA, has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis, na-SPMS, Expanded Access, EA, Program to expand from 10 patients to a total of 30 patients. To date, of the 10 participating patients, two patients have been dosed for more than one year and eight additional patients have been dosed for six months, all without serious side effects. All patients have either stabilized or improved on treatment with foralumab, and no patients have declined in key clinical measures. Additionally, 70% of these patients have seen a measurable improvement in fatigue. These data are the first to combine PET imaging with a novel ligand, immune-biomarkers, clinical measures and comprehensive safety data endpoints in patients receiving long-term intranasal foralumab. In November 2023 Tiziana initiated a Phase 2a trial in na-SPMS. Patients not eligible for the Phase 2a trial may now be considered for this expanded EA program.