Tiziana Responds to UK Call for Development of Innovative ‘Take Home’ Treatments for COVID-19 Disease

NEW YORK and LONDON, June 17, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases announces that it has submitted a grant to the United Kingdom COVID Therapeutics Advisory Panel (UK-CTAP) to support further clinical development of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, as an innovative ‘Take Home’ approach for treatment of non-hospitalized patients with COVID-19. This is in response to a call from the UK government for proposals to study therapies that can be delivered at home and avoid hospitalization of patients.

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 disease. Previously, we announced the successful completion of a clinical study with nasally administered Foralumab in patients with COVID-19 in Brazil. Results from this study demonstrated that the treatment induced immunomodulatory effects capable of providing clinical benefit to Covid-19 patients. Importantly, the direct delivery of Foralumab using a nasal spray ‘Take Home’ device to the nasal passage and respiratory tract rapidly suppressed lung inflammation, as evident from CT scans and reduced systemic markers of inflammation including interleukin-6 and C-reactive protein (https://www.tizianalifesciences.com/news-item?s=2021-02-02-tiziana-rep ...).These clinical results warrant further clinical development of nasally administered Foralumab in patients with Covid-19.

Separately, Tiziana Life Sciences is also completing processes to initiate another clinical trial in COVID-19 hospitalized patients in Brazil. The objective of this study is to evaluate whether nasally administered Foralumab could be useful for hospitalized patients with severe inflammation. Since, nasal administration with Foralumab is an immunomodulatory approach, it is possible that this ‘Take Home’ treatment approach could be useful for treatment of other COVID-19 variants, including the variants identified in South Africa, Brazil, the UK and the Delta variant in India.