TIDMTILS
RNS Number : 7696C
Tiziana Life Sciences PLC
23 June 2021
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 & LONDON, June 23, 2021 - 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
ug. Additionally, the study will also evaluate the effect of
Foralumab on resolution of symptoms by chest CT, inflammatory
biomarkers, T-cell subpopulations, safety and mucosal inflammatory
response following 14 days of intranasal administration.
"Our experience is uniquely suited to the needs of this Phase 2
study as we are able to pull from past outbreak experience,
including rapid study start-up in research-naïve areas to
leveraging existing global research networks and contributing to
local health systems," said Ted FitzGerald, FHI Clinical President
and CEO. "We excel at addressing the complex aspects of infectious
disease trials that require thorough planning and contingency
planning."
"We are pleased to move forward with FHI Clinical on our next
COVID-19 trial. After a successful proof-of-mechanism trial in mild
to moderate COVID-19 outpatients with intranasal Foralumab earlier
this year, the next step is to test it in more severe hospitalized
patients with pulmonary inflammation," said Dr. Neil Graham, Chief
Medical Officer at Tiziana Life Sciences.
The person who arranged for the release of this announcement on
behalf of the Company was Dr. Kunwar Shailubhai, Chief Executive
Officer and Chief Scientific Officer of the Company.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF
DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT
2018) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS
INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE
IN THE PUBLIC DOMAIN.
About Foralumab
Foralumab (formerly NI-0401), the only entirely human anti-CD3
mAb, shows reduced release of cytokines after IV administration in
patients with Crohn's disease with decreases in the classic side
effects of cytokine release syndrome and improves the overall
safety profile of Foralumab. In a humanized mouse model (NOD/SCID
IL2<GAMMA>c-/-), it was shown that whilst targeting the T
cell receptor, orally administered Foralumab modulates immune
responses of the T cells, enhances regulatory T-cells (Tregs) and
thus provides therapeutic benefit in treating inflammatory and
autoimmune diseases without the occurrence of potential adverse
events usually associated with parenteral mAb therapy (Ogura M. et
al., 2017). Based on animal studies, the nasal and oral
administration of Foralumab offers the potential for the
immunotherapy of autoimmune and inflammatory diseases in a safe
manner by the induction of Tregs.
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.
1-800-RED-CHIP (733-2447)
or
407-491-4498
dave@redchip.com
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END
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