Tiziana Life Sciences PLC Tiziana Applies for Grant from UK-CTAP
June 17 2021 - 2:00AM
RNS Non-Regulatory
TIDMTILS
Tiziana Life Sciences PLC
17 June 2021
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 (
https://www.tizianalifesciences.com/news-item?s=2021-02-02-tiziana-reports-positive-data-from-the-clinical-study-of-nasal-administration-with-foralumab-its-proprietary-fully-human-anti-cd3-monoclonal-antibody-in-covid-19-patients-in-brazil
).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.
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.
For further enquiries:
United Kingdom:
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
United States:
Investors:
Dave Gentry, CEO
RedChip Companies Inc. 407-491-4498
dave@redchip.com
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