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Tiziana Life Sciences Announces Initiation of Clinical Trial in a Secondary Progressive Multiple Sclerosis (SPMS) Patient with Nasal Administration of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, Under an Individual Patient Expanded Access P...
Tiziana Life Sciences Announces Initiation of Clinical Trial in a Secondary Progressive Multiple Sclerosis (SPMS) Patient with Nasal Administration of
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"Tiziana Life Sciences Announces Initiation of Clinical Trial in a Secondary Progressive Multiple Sclerosis (SPMS) Patient with Nasal Administration of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, Under an Individual Patient Expanded Access Program \n The first patient with SPMS was dosed on May 24, 2021 with nasally administered Foralumab. The treatment regimen will continue for six months to examine long-term safety, tolerability and clinical responses.Previous clinical studies in healthy volunteers and COVID-19 patients showed that nasally administered Foralumab is well-tolerated with no apparent severe adverse events (SAEs) when dosed for up to 10 consecutive days. Results from these studies showed strong anti-inflammatory effects of the treatment regimen. NEW YORK and LONDON, May 25, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to announce that the first patient with secondary progressive multiple sclerosis (SPMS) was dosed with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, at the Brigham and Women’s Hospital (BWH), Harvard Medical School, Boston, MA. Nasal Foralumab 50 mcg (25 mcg/nostril) will be administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, will continue for six months to evaluate routine safety, tolerability, and neurological behaviors. The study will also examine microglial activation, by positron emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the treatment regimen. Previously, Tiziana completed a Phase 1 trial of a single-site, double-blind, placebo-controlled, multiple ascending dose (MAD) once a day dosing for 5 consecutive days with nasally administered Foralumab in healthy subjects. The treatment was well-tolerated with no drug-related safety issues reported at doses of up to 250 mcg. (https://www.tizianalifesciences.com/news-item?s=2019-09-10-tiziana-reports-phase-1-clinical-data-demonstrating-nasal-treatment-with-foralumab-was-well-tolerated-and-produced-positive-trend-in-biomarkers...