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TLSA 資訊
TLSA 事件
Tiziana Life Sciences Doses Last Patient in Phase 2a Trial
Tiziana Life Sciences announced that the last patient in its ongoing Phase 2a clinical trial has received their first dose of intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis. Topline data is expected in late Q3/early Q4 of 2026, and is planned to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis and ECTRIMS meeting in Toronto, Canada in October 2026.
Tiziana Life Sciences Completes Patient Enrollment in MS Clinical Trial
Tiziana Life Sciences announces that patient enrollment has been completed in its randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis. Topline data is expected in late Q3 of 2026, and will also to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis and ECTRIMS meeting in Toronto, Canada in October 2026. The trial, known as INFORM-MS, is the first Phase 2 placebo-controlled study of intranasal foralumab, marking a significant milestone in the clinical development of this novel anti-CD3 monoclonal antibody for neurodegenerative and neuroinflammatory diseases. The multicenter study has enrolled 48 patients across multiple leading U.S. sites to receive one of two doses of intranasal foralumab or placebo over a 12-week treatment period, with assessments including PET imaging for microglial activation, MRI, clinical evaluations, and biomarkers. Following the completion of the blinded phase, all participants including those who initially received placebo will have the opportunity to receive intranasal foralumab during a six-month open label extension phase. The OLE is designed to assess long term safety and sustained benefit of foralumab in the na-SPMS patient population.
Tiziana Life Sciences Updates Clinical Data on Intranasal Foralumab
Tiziana Life Sciences announced updated clinical data from its ongoing expanded access program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis. The data, updated from March 2025 to as of March 2026, demonstrate that intranasal foralumab continues to be extremely well tolerated over extended treatment durations. Patients showed encouraging trends in stabilization of disability as measured by the Expanded Disability Status Scale and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale. Foralumab was well tolerated with no new safety signals identified. The company observed a favorable trend toward disease stabilization. Overall, 64% of patients achieved a clinically meaningful improvement of greater than or equal to four points in their MFIS score.
Tiziana Life Sciences Reports Initial PET Imaging Results in MSA Patients
Tiziana Life Sciences announced initial quantitative PET imaging results from the first two patients with Multiple System Atrophy in a Phase 2 clinical trial treated with intranasal foralumab. The company reported that quantitative analysis demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment. In the first two treated patients, investigators observed up to approximately 35% reduction in standardized uptake value and approximately 24% reduction in standardized uptake value ratio in affected areas. "This is the third indication that we have seen a marked reduction in inflammation on PET scans following treatment with intranasal foralumab," said Ivor Elrifi, CEO.
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