TIDMTILS
RNS Number : 6591Z
Tiziana Life Sciences PLC
25 May 2021
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.
Tiziana Life Sciences Announces Initiation of Clinical Trial in
a Secondary Progressive Multiple Sclerosis (SPMS) Patient with
Nasal Administration of Foralumab, a Fully Human Anti-CD3
Monoclonal Antibody, Under an Individual Patient Expanded Access
Program
-- The first patient with SPMS was dosed on May 24, 2021 with
nasally administered Foralumab. The treatment regimen will continue
for six months to examine long-term safety, tolerability and
clinical responses.
-- Previous clinical studies in healthy volunteers and COVID-19
patients showed that nasally administered Foralumab is
well-tolerated with no apparent severe adverse events (SAEs) when
dosed for up to 10 consecutive days. Results from these studies
showed strong anti-inflammatory effects of the treatment
regimen.
New York/London, 25 May 2021 - Tiziana Life Sciences plc
(NASDAQ: TLSA, LSE: TILS) ("Tiziana" or the "Company"), a
biotechnology company focused on innovative therapeutics for
inflammatory diseases and cancers, is pleased to announce that the
first patient with secondary progressive multiple sclerosis (SPMS)
was dosed with nasally administered Foralumab, a fully human
anti-CD3 monoclonal antibody, at the Brigham and Women's Hospital
(BWH), Harvard Medical School, Boston, MA. Nasal Foralumab 50 mcg
(25 mcg/nostril) will be administered in 3-week cycles, with 3
times/week dosing for the first 2 weeks followed by 1 week of rest
period. This first-ever clinical study in SPMS patients, under an
Individual Patient Expanded Access IND, will continue for six
months to evaluate routine safety, tolerability, and neurological
behaviors. The study will also examine microglial activation, by
positron emission tomography (PET), immunological and
neurodegenerative markers to assess clinical responses following
the treatment regimen.
Previously, Tiziana completed a Phase 1 trial of a single-site,
double-blind, placebo-controlled, multiple ascending dose (MAD)
once a day dosing for 5 consecutive days with nasally administered
Foralumab in healthy subjects. The treatment was well-tolerated
with no drug-related safety issues reported at doses of up to 250
mcg. (
https://www.tizianalifesciences.com/news-item?s=2019-09-10-tiziana-reports-phase-1-clinical-data-demonstrating-nasal-treatment-with-foralumab-was-well-tolerated-and-produced-positive-trend-in-biomarkers-of-immunomodulation-and-anti-inflammation-in-healthy-volunteers
)
Subsequently, Tiziana reported positive data from a clinical
study with nasally administered Foralumab in COVID-19 patients in
Brazil. Results from this clinical study demonstrated that nasally
administered Foralumab at 100 mcg/day for consecutive 10 days was
well-tolerated and there were no apparent severe adverse events.
The clinical results demonstrated that the treatment provided
significant reduction of lung inflammation together with a
reduction in interleukin-6 (IL-6) and C-reactive protein (CRP),
biomarkers of inflammation, in the blood samples taken from
patients (
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
)
Dr. Howard Weiner, Robert Kroc Professor of Neurology at Harvard
Medical School said, "Nasally administered anti-CD3 is an exciting,
novel approach that has the ability to provide safe treatment for a
form of MS that currently has no effective treatment. We are
excited to examine this first-in-class approach to treat patients
with SPMS for whom no effective treatment option is currently
available."
Dr. Tanuja Chitnis, Professor of Neurology at Harvard Medical
School and senior neurologist at the BWH, adds, "Effective and
targeted treatments for progressive MS are urgently needed. Nasal
Foralumab could revolutionize treatment for this disabling form of
disease."
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 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 is a dual listed (NASDAQ: TLSA, UK
LSE: TILS) biotechnology company that focuses on the discovery and
development of novel molecules to treat human diseases in oncology,
inflammation and infectious diseases. In addition to Milciclib, the
Company will be shortly initiating Phase 2 studies with orally
administered Foralumab for Crohn's Disease and nasally administered
Foralumab for progressive multiple sclerosis. Foralumab is the only
fully human anti-CD3 monoclonal antibody ("mAb") in clinical
development in the world. This Phase 2 compound has potential
application in a wide range of autoimmune and inflammatory
diseases, such as Crohn's Disease, multiple sclerosis, type-1
diabetes ("T1D"), inflammatory bowel disease ("IBD"), 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 inflammation, especially for
treatment of COVID-19 patients.
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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