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Tiziana Announces Publication of a Peer Reviewed Article on Data from the Clinical Trial with Intranasally Administered Foralumab, Its Proprietary Fully Human Anti-CD3 Monoclonal Antibody, in Mild to Moderate COVID-19 Patients in Brazil
Nasally administered Foralumab, once a day for 10 consecutive days, was well-tolerated and produced significant reduction in lung inflammation as assessed by
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"Nasally administered Foralumab, once a day for 10 consecutive days, was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography (CT) scanningThis anti-inflammatory effect of treatment was strongly supported by a reduction in serum levels of pro-inflammatory biomarkers Interleukin-6 (IL-6), IL-18 and C-reactive protein (CRP)As a next step, Tiziana will be shortly initiating a Phase 2 Proof-of-concept study in Brazil to evaluate safety, tolerability, and efficacy of intranasal Foralumab in a larger number of hospitalized patients with COVID-19 NEW YORK and LONDON, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS) (\"Tiziana\" or the \"Company\"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces publication of a scientific article in the peer-reviewed journal Frontiers in Immunology titled \"Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study\"(1). The study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA) and INTRIALS, a full-service Latin American CRO based in São Paulo, Brazil. The aim of the study was to assess safety of intranasal Foralumab and evaluate its potential benefits in treating immune hyperactivity and lung inflammation in mild to moderate COVID-19 patients who were outpatients at the Santa Casa de Misericordia de Santos Hospital in Brazil. Thirty-nine patients were randomized into three cohorts: no Foralumab treatment (control), nasal Foralumab (100 ug) + Dexamethasone (6 mg orally on days 1-3), and nasal Foralumab (100 ug) alone administered for 10 consecutive days. All arms were allowed to continue standard of care medications. To view the online publication, please click here:http://journal.frontiersin.org/article/10.3389/fimmu.2021.709861/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Immunology&id=709861 Clinical DataTreatment with Foralumab was well-tolerated, and all patients completed the study. No serious adverse events were observed. Eleven patients (28%) experienced an adverse eve...