Full Press Release Details
Tiziana Responds to UK Call for Development
of Innovative Take Home' Treatments for COVID-19 Disease
NEW YORK & LONDON, June 17, 2021 - 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
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.
About Tiziana Life Sciences
Tiziana Life Sciences plc (NASDAQ: TLSA,
LSE: TILS) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease
in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab
in COVID-19, multiple sclerosis, and Crohns Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody
in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases,
such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis
and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin
6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.
Forward-Looking Statements
Certain statements made in this announcement are
forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations,
estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,'
'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not
guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond
the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted
in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance
on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking
statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake
any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated
events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
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