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
August 17 2021 - 1:00AM
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 Inflammation and Blood Inflammatory 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 DataTreatment 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
Reference1. 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 Inflammation and Blood Inflammatory 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 ForalumabForalumab
(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 IL2γc-/-), 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
SciencesTiziana 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
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 plc |
|
+44 (0)20 7495 2379 |
Gabriele Cerrone, Chairman and founder |
|
|
|
United States: |
Investors: |
Dave Gentry, CEO |
RedChip Companies Inc. |
407-491-4498 |
dave@redchip.com |
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