Business
Tiziana Enters a Collaboration Agreement with FHI Clinical to Conduct a Phase 2 Clinical Trial for Treating Hospitalized Severe COVID-19 Patients with Intranasal Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody
NEW YORK and LONDON, June 23, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS), ("Tiziana" or the "Company"), a biotechnology
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"NEW YORK and LONDON, June 23, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS), (\"Tiziana\" or the \"Company\"), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, announces that it has signed an agreement with FHI Clinical, a global clinical contract research organization (CRO), to conduct a Phase 2 Proof-of-concept study in Brazil to evaluate the safety, tolerability and efficacy of intranasal Foralumab in hospitalized patients with severe coronavirus disease 2019 (COVID-19) and pulmonary inflammation. A subsidiary of FHI 360, FHI Clinical specializes in the clinical development of drugs for infectious diseases (https://www.fhiclinical.com). The company’s involvement with COVID-19 includes Phase 1 to Phase 3 clinical trials for vaccines and therapeutics, as well as observational studies to collect data about the characteristics and course of infection. With experience conducting related studies across 16 countries and 43 states in the United States, FHI Clinical has a large network of clinical sites throughout the world to expedite COVID-19 trials. In this clinical trial, Foralumab will be delivered intranasally through a metered-dose nasal atomization device. Nasal administration of Foralumab is a highly innovative approach to treat patients with autoimmune diseases where the immune system may be dysregulated. Several studies have suggested that there is dysregulation in the immune system of patients with COVID-19. This randomized, placebo-controlled, double-blind, proof-of-concept study is designed to expand on the preliminary findings of safety, tolerability and efficacy of intranasal administration of Foralumab observed in mild to moderate non-hospitalized COVID-19 patients (https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-life-sci-plc-positive-data-nasal-administration). Thus, this study will examine attenuation of pulmonary pathology in hospitalized patients with severe COVID-19. Up to seven sites in Brazil will be engaged to conduct this study. Eighty hospitalized patients with severe COVID-19 and evidence of pulmonary involvement on a computed tomography (CT) scan at screening will be enrolled. Patients will be randomized 1:1 to receive intranasal Foralumab 100 µg. Additionally, the study wil...