TIDMTILS
RNS Number : 8499D
Tiziana Life Sciences PLC
02 November 2020
Tiziana Life Sciences PLC
("Tiziana" or "the Company")
Tiziana Announces Initiation of Clinical Trial for COVID-19
Patients in Brazil with Nasally Administered Foralumab, a Fully
Human Anti-CD3 Monoclonal Antibody
London/New York, 2 November 2020 - 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
initiation of a collaborative clinical study investigating nasally
administered Foralumab either alone or in combination with orally
administered dexamethasone in COVID-19 patients in Brazil. In view
of the importance and urgency, scientific teams at the Harvard
Medical School, Santa Casa de Misericórdia de Santos Hospital
(Jabaquara, Santos, Brazil) and at Tiziana are closely
collaborating to facilitate initiation of this study in expedited
time frames. This clinical trial will be coordinated by the team at
INTRIALS, a leading, full-service Latin America Clinical Research
Organisation, (CRO) based in Sao Paulo City, Brazil. The clinical
data from this trial is expected to be available by the end of this
year.
Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences stated:
-- "Brazil has reported almost 5.5 million Coronavirus cases and
159,000 deaths and is considered a global epicenter of the
outbreak. Brazil is currently experiencing almost 1,000 deaths per
day. Therefore, our clinical study is both timely and a potential
life changer for COVID-19 patients. The scientific concept, through
activation of nasal mucosal immunity via nasally administered
Foralumab, aims to fight the virus in the respiratory tract and
lungs". The clinical study will start dosing patients on 3 November
2020 with data expected to be available before the end of 2020
-- Since reduced or defective levels of T regulatory (Tregs)
cells in the blood seem to be associated with the severity of
COVID-19 and acute respiratory distress syndrome (ARDS), nasally
administered Foralumab, by acting locally, could potentially
suppress a 'cytokine storm' and hyperinflammation in the
respiratory tract and lungs of COVID-19 patients
-- A patent application was filed in July 2020 to protect the
potential use of nasally administered Foralumab for the treatment
of COVID-19 either alone or in combination with other anti-viral
drugs.
Dr Howard Weiner, who is 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, and a Scientific Advisor to the Company, 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. Results from studies, conducted in our laboratory have
established that nasal administration of anti-CD3 induces Tregs
that can suppress inflammation and ameliorate diseases in animal
models. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell
responses shown to cause lung damage in COVID-19. This scientific
advancement provides the basis to move forward with clinical
development of nasally administered Foralumab in COVID-19 disease."
He continued, "My colleague Dr. Thais Moreira worked very closely
with clinicians at the Brazilian hospital and the team at INTRIALS
to expedite this highly innovative first-in-class study for
treating COVID-19 disease."
Dr. Rogério Dedivitis, the Clinical director of Santa Casa de
Santos, stated: "The Santa Casa hospital, the first hospital
founded in Brazil almost 500 years ago, is very pleased to be
involved in such an important international clinical study. We are
excited and confident that this study will contribute to the better
understanding of COVID-19 disease, and importantly also benefit our
patients."
The cytokine storm and hyperinflammation resulting in severe
lung damage, followed by respiratory failure are the main
underlying reasons for morbidity and mortality in COVID-19 patients
(1). Recent clinical evidence suggests that the level of peripheral
Tregs is prominently reduced in severely ill COVID-19 patients (2).
The clinical data from a recently completed clinical study
indicated that the nasal administration of Foralumab stimulated
production of Tregs in healthy volunteers (
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
), suggesting that nasal treatment with Foralumab may improve
clinical outcome by stimulating Tregs in patients. This is an
innovative approach, which could also be useful for treatment of
patients with Middle Eastern Respiratory Syndrome (MERS), Severe
Acute Respiratory Syndrome (SARS-CoV-1), COVID-19 and Acute
Respiratory Distress Syndrome (ARDS) because depletion of
functional Tregs is commonly observed in these diseases.
Cited References
1. Huang C, Wang Y, Li X, et al. Clinical features of patients
infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020;
395: 497-506. doi:10.1016/S0140-6736(20)30183-5
2. Chen G, Wu D, Guo W, et al. Clinical and immunological
features of severe and moderate coronavirus disease 2019. J Clin
Invest 2020; 130: 2620-2629. doi:10.1172/JCI137244
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.
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014. 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.
For further enquiries:
United Kingdom Investors:
Tiziana Life Sciences plc +44 (0)20 7495
Gabriele Cerrone, Chairman and founder 2379
Cairn Financial Advisers LLP (Nominated Adviser) +44 (0)20 7213
Liam Murray / Jo Turner 0880
Optiva Securities Limited (Broker) + 44 (0)20 3981
Robert Emmet 4173
United States Investors:
Dave Gentry Office 1 800 RED CHIP (733
RedChip Companies Inc. 2447)
Cell 407-491-4498 (USA)
dave@redchip.com
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