Tiziana Responds to UK Call for Development of Innovative ‘Take Home’ Treatments for COVID-19 Disease
June 17 2021 - 2:00AM
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: |
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United Kingdom: |
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Tiziana Life Sciences plc |
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Gabriele Cerrone, Chairman and founder |
+44 (0)20 7495 2379 |
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United States: |
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Investors: |
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Dave Gentry, CEO |
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RedChip Companies Inc. |
407-491-4498 |
dave@redchip.com |
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