TIDMTILS
Tiziana Life Sciences PLC
04 January 2021
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana announces completion of the clinical trial with nasally
administered Foralumab, its proprietary fully human anti-CD3
monoclonal antibody, for the treatment of COVID-19 patients in
Brazil
- Anecdotal feedback from Foralumab-treated patients was
positive and suggests that the treatment was well-tolerated
- The scientific approaches underlying this clinical study could
potentially be effective against SARs, MERS, and all variants of
coronaviruses
- This trial is the first to evaluate nasally administered
Foralumab to improve the immune system's fight against
coronaviruses
New York/London, 4 January 2021 - Tiziana Life Sciences plc
(Nasdaq: TLSA / AIM: TILS) ("Tiziana" or the "Company"), a
biotechnology company focused on innovative therapeutics for
oncology, inflammation, and infectious diseases, announces the
completion of its clinical study in Brazil investigating nasally
administered Foralumab, its proprietary human monoclonal antibody,
either alone or in combination with orally administered
dexamethasone in COVID-19 patients.
The clinical study was completed in collaboration with
scientific teams at the Harvard Medical School (Boston, USA), Santa
Casa de Misericórdia de Santos Hospital (Santos, Brazil) and
INTRIALS, a world-class, full-service Latin American CRO based in
São Paulo, Brazil. The last patients in the trial received their
final dose on 21 December 2020.
The topline data from the trial is expected to be available in
January 2021.
Because COVID-19 enters through the nasal and respiratory
passage, the proprietary nasal formulation and nasal delivery of
Foralumab is an innovative approach to provide immediate relief to
COVID-19 patients.
Dr. 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)
commented:
"Nasal administration of Foralumab to modulate the human immune
system is a potentially transformative approach for treating
patients with a variety of human diseases with dysregulated immune
systems. Preclinical data from our laboratory have shown that the
nasal administration of anti-CD3 stimulates Tregs that can suppress
inflammation and ameliorate inflammatory diseases. Furthermore,
nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are
known to cause lung damage in COVID-19 patients."
Dr Thais Moreira, the lead scientist and coordinator of the
clinical trial, stated:
"We are delighted to receive positive feedback from patients
treated in the clinical trial. Among the positive results patients
reported, the most common was that the treatment resulted in the
rapid improvement in smell sensation, which is frequently lost in
COVID-19 patients."
Dr. Kimble Matos, the lead coordinating physician of the study,
commented:
"The observations made during the Clinical study did not show
any adverse events."
The clinical study enrolled a total of 39 patients with moderate
to severe COVID-19 who did not require the use of a ventilator at
the beginning of the study. This study had three cohorts: control
(n=16), nasally administered Foralumab (n=12), and nasally
administered Foralumab with 3 days of priming with orally
administered 6 mg dexamethasone (n=11).
-- The primary endpoint of this study was safety of the
treatment, and secondary endpoints were to evaluate the effect of
treatment on disease severity symptoms, nasal tolerance, sense of
smell, and biomarkers for disease progression. The pharmacokinetics
of nasally administered Foralumab will also be evaluated.
-- Patient reported outcome to assess clinical responses related
to COVID-19 symptoms, as per the FDA guidelines, will also be
collected.
Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences,
commented:
"While we expect to get the topline data in January 2021, we are
delighted with the positive feedback received from the treated
patients. This is the first-in-class and scientifically logical
approach to improve the human immune system by stimulating Tregs to
suppress lung inflammation, and to dampen cytotoxic CD8+ T cell
responses in the nasal and respiratory tract, the primary sites of
the COVID-19 virus.
"We believe this approach could potentially provide benefits to
patients already infected with COVID-19 and its newly identified
variants. Thus, our therapeutic approach to provide rapid relief to
patients already suffering with the diseases is particularly
important, because vaccination is primarily to prevent COVID-19
infection, but it may not be useful for treatment of COVID-19
patients."
A further announcement will be made in due course.
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 (CRS) 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 AIMS: 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.
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
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