TIDMTILS
RNS Number : 8048Z
Tiziana Life Sciences PLC
26 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 Reports Data Indicating Significant Immunomodulation
effects on Immune and Inflammatory Biomarkers with Nasally
Administered Foralumab in Healthy Volunteers.
New York/London, 26 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, today provided an update on
further analysis of lymphocyte subsets from blood samples from a
Phase 1 study with nasally administered Foralumab in healthy
volunteers. Results exhibiting statistically significant
immunomodulatory effects on CD8 cytotoxic T-lymphocytes and other
inflammatory biomarkers were observed. This Phase 1 trial,
conducted at the Brigham and Women's Hospital, Harvard Medical
School, Boston, MA, was a single-site, double-blind,
placebo-controlled, dose-ranging study with nasally administered
Foralumab at 10, 50 and 250 mcg per day, consecutively for 5 days
in healthy volunteers. The treatment was well-tolerated at all
doses and there were no apparent symptoms of severe toxicity.
Importantly, the treatment showed significant positive effects at
50 mcg/day dose (compared to other dose and placebo groups) on
T-cell subsets and inflammatory biomarkers. These data support
other clinical and pre-clinical studies showing that this route of
administration is capable of inducing site-targeted
immunomodulation and anti-inflammatory effects. Furthermore these
pharmacodynamic data point to a clinical dose range that Tiziana
intends to test in further clinical development among MS
patients.
Highlights of clinical and immunologic data
-- Nasally administered Foralumab was well tolerated and there
were no apparent symptoms of severe toxicity or cytokine release
syndrome.
-- Systemic levels of Foralumab were below the lower
quantitation limit of 8 ng/mL suggesting that nasally administered
Foralumab appears to exert its effects via nasal epithelium
utilizing local and lymphatic immune systems directly.
-- Most prominent effects among cytotoxic T-cell subsets were
observed in the 50mcg group compared to 10mcg, 250mcg and placebo
groups.
-- The observed effects in the 50mcg dose group were the following:
a. Statistically significant reductions from baseline in CD8_Tem
cytotoxic T-cell subset through 14 days and CD8_TEMRA,
CD8_GranzymeB, CD8_Perforin subsets through 21 days
b. Statistically significant increase from baseline in CD8_naive subset through day 21
c. Statistically significant stimulation in production of
anti-inflammatory cytokine IL-10 along with suppressed production
of pro-inflammatory cytokine IFN-<GAMMA>, suggested a
positive trend for immunomodulation and anti-inflammatory
effect.
These observed clinical responses on biomarkers, indicative of
immunomodulation and anti-inflammatory, are consistent with the
positive clinical data observed 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
10 consecutive days was not only well-tolerated but it also showed
significant reduction of lung inflammation along with statistically
reduced levels of interleukin-6 (IL-6) and C-reactive protein
(CRP), 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
).
"Nasal administration of Foralumab is a unique approach to treat
patients with neurodegenerative diseases such as progressive MS ,
amyotrophic lateral sclerosis (ALS) and Alzheimer's Disease (AD).
This study demonstrates for the first-time that nasally
administered Foralumab, at the identified optimal dose of 50
mcg/day, induces immunomodulatory effects capable of providing
clinical benefit to treated subjects. These data along with results
from our recently completed trial in COVID-19 patients in Brazil
suggest a dose-range of 50 mcg-150mcg could be used for future
clinical development of nasally administered Foralumab. This is a
major accomplishment providing the scientific rationale to move
forward with further clinical development of nasally administered
Foralumab in patients with neurodegenerative diseases," commented
Dr. Howard L. Weiner, Chair of the Scientific Advisory Board of
Tiziana Life Sciences and Professor of Neurology at Harvard Medical
School. He added that "both oral and nasal administration routes
are physiologic approaches to stimulate the mucosal immune system
to induce disease modifying immunomodulation. Our immediate focus
is on developing Foralumab for treatment of progressive MS."
"The demonstration of the positive immunomodulatory effects
providing a recommended dose-range is important to move forward
with further studies in the progressive MS population", stated Dr.
Tanuja Chitnis, the study PI at the Brigham and Women's
Hospital.
The person who arranged for the release of this announcement on
behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of
Tiziana.
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 while targeting the T cell
receptor, orally administered Foralumab modulates immune responses
of the T cells, enhances 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.
Preclinical studies on nasal and oral administration with
Anti-CD3 mAbs
Preclinical and clinical studies have shown that mucosal
induction of Tregs by oral or nasal administration of anti-CD3 mAbs
is an innovative approach to treat autoimmune and anti-inflammatory
diseases (Kuhn and Weiner 2016). Nasally administered anti-CD3 mAbs
were shown to ameliorate disease in an animal model of multiple
sclerosis by inducing IL-10(+) LAP(+) (latency-associated peptide)
T cells, demonstrating nasal anti-CD3 mAbs as a new approach to
treat progressive forms of multiple sclerosis and other types of
chronic CNS inflammation. Additionally, nasally administered
anti-CD3 mAbs suppressed lupus in lupus-prone mice (BWF1) by
inducing IL-10 and TGF-<BETA> dependent mechanisms associated
with a suppression of IL-17 and IL-21 pro-inflammatory
cytokines.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that
focuses on the discovery and development of novel molecules to
treat human disease in oncology and immunology. In addition to
Milciclib, the Company is also developing Foralumab for liver
diseases. Foralumab is the only fully human anti-CD3 monoclonal
antibody in clinical development in the world. This Phase 2
compound has potential application in a wide range of autoimmune
and inflammatory diseases, such as multiple sclerosis, crohn's
disease, COVID-19, type-1 diabetes (T1D), ulcerative colitis, ,
psoriasis and rheumatoid arthritis, where modulation of a T-cell
response is desirable.
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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