Tiziana Enters a Collaboration Agreement with FHI Clinical to Conduct a Phase 2 Clinical Trial for Treating Hospitalized Seve...
23 June 2021 - 4:00PM
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
µg. 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.
About ForalumabForalumab
(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 IL2γc-/-), 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 SciencesTiziana 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
StatementsCertain 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 plcGabriele Cerrone, Chairman and
founder |
+44 (0)20 7495 2379 |
|
|
United States:Investors:Dave
Gentry, CEORedChip Companies Inc.1-800-RED-CHIP
(733-2447)or407-491-4498dave@redchip.com |
|
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