TIDMTILS
Tiziana Life Sciences PLC
17 August 2021
Tiziana Announces Publication of a Peer Reviewed Article on Data
from the Clinical Trial with Intranasally Administered Foralumab,
Its Proprietary Fully Human Anti-CD3 Monoclonal Antibody, in Mild
to Moderate COVID-19 Patients in Brazil
-- Nasally administered Foralumab, once a day for 10 consecutive
days, was well-tolerated and produced significant reduction in lung
inflammation as assessed by computerized tomography (CT)
scanning
-- This anti-inflammatory effect of treatment was strongly
supported by a reduction in serum levels of pro-inflammatory
biomarkers Interleukin-6 (IL-6), IL-18 and C-reactive protein
(CRP)
-- As a next step, Tiziana will be shortly initiating a Phase 2
Proof-of-concept study in Brazil to evaluate safety, tolerability,
and efficacy of intranasal Foralumab in a larger number of
hospitalized patients with COVID-19
New York/London, August 17, 2021 - Tiziana Life Sciences plc
(Nasdaq: TLSA / LSE: TILS) ("Tiziana" or the "Company"), a
biotechnology company focused on innovative therapeutics for
oncology, inflammation, and infectious diseases, announces
publication of a scientific article in the peer-reviewed journal
Frontiers in Immunology titled "Nasal Administration of Anti-CD3
Monoclonal Antibody (Foralumab) Reduces Lung In ammation and Blood
In ammatory Biomarkers in Mild to Moderate COVID-19 Patients: A
Pilot Study"(1). The study was completed in collaboration with
scientific teams at the Harvard Medical School (Boston, USA) and
INTRIALS, a full-service Latin American CRO based in São Paulo,
Brazil. The aim of the study was to assess safety of intranasal
Foralumab and evaluate its potential benefits in treating immune
hyperactivity and lung inflammation in mild to moderate COVID-19
patients who were outpatients at the Santa Casa de Misericordia de
Santos Hospital in Brazil. Thirty-nine patients were randomized
into three cohorts: no Foralumab treatment (control), nasal
Foralumab (100 ug) + Dexamethasone (6 mg orally on days 1-3), and
nasal Foralumab (100 ug) alone administered for 10 consecutive
days. All arms were allowed to continue standard of care
medications. To view the online publication, please click here:
http://journal.frontiersin.org/article/10.3389/fimmu.2021.709861/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Immunology&id=709861
Clinical Data
Treatment with Foralumab was well-tolerated, and all patients
completed the study. No serious adverse events were observed.
Eleven patients (28%) experienced an adverse event, including
headache (n=4), burning in the nostril (n=1), retrosternal pain
(n=2), pustular lesions and itching in cervical area (n=1), dysuria
(n=1), tachycardia associated with anxiety (n=1), and insomnia
(n=1). Treatment with Foralumab resulted in significant reduction
in lung inflammation. The CT scan of the lungs obtained prior to
the start of treatment and at study completion revealed a marked
improvement in clearance of lung infiltrates, predominantly in
patients receiving Foralumab alone as compared to patients in the
control cohort. The CT scanning data strongly correlated with
significant reduction in levels of inflammatory markers, such as
IL-6 levels (69%; p=0.031) and CRP (85%; p=0.032) at day 10.
"Dr. Thais Moreira and other researchers at the Brigham and
Women's Hospital (BWH) have been engaged with the development of
nasal spray of anti-CD3 monoclonal antibodies for treatment of
neurodegenerative diseases. I am pleased our research has led to
the development of this novel approach with Foralumab nasal spray
for the treatment of COVID-19 patients. This technology is
particularly important, because COVID-19 causes immune
hyperactivity, and we believe nasal delivery of Foralumab could
rapidly suppress inflammation both in the lung and systemically to
provide immediate relief to COVID-19 patients," said Professor
Howard Weiner, the Robert L. Kroc Professor of Neurology at the
Harvard Medical School, Director and Founder of the Partners
Multiple Sclerosis Center, and Co-Director of the Ann Romney Center
for Neurologic Diseases at the Brigham & Women's Hospital.
Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences,
commented: "We are very pleased with the publication of the article
in a peer-reviewed journal. The clinical findings reported in the
article suggest that the nasal spray of Foralumab could be
developed as a take home treatment, circumventing the obstacles
associated with intravenous treatments for COVID-19 and its
variants. We are looking forward to initiating shortly the next
clinical study evaluating Foralumab nasal spray in hospitalized
COVID-19 patients."
Cited Reference
1. Moreira TG, Matos KTF, De Paula GS, Santana TMM, Da Mata RG,
Pansera FC, Cortina AS, Spinola MG, Keppeke GD, Jacob J, Palejwala
V, Chen K, Izzy S, Healey BC, Rezende RM, Dedivitis RA, Shailubhai
K and Weiner HL (2021) Nasal administration of Anti-CD3 Monoclonal
Antibody (Foralumab) Reduces Lung In ammation and Blood In ammatory
Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study.
Front. Immunol. 12:709861. doi: 10.3389/fimmu.2021.709861
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 (TZLS-401, formerly NI-0401), the only entirely human
anti-CD3 mAb, shows reduced release of cytokines as compared to
other anti-CD3 mAbs 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 while 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 Clin Immunol 183, 240-246). 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.
407-491-4498
dave@redchip.com
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRAPFMTTMTIBTIB
(END) Dow Jones Newswires
August 17, 2021 02:00 ET (06:00 GMT)
Tiziana Life Sciences (LSE:TILS)
Historical Stock Chart
From Sep 2024 to Oct 2024
Tiziana Life Sciences (LSE:TILS)
Historical Stock Chart
From Oct 2023 to Oct 2024