TIDMTILS
RNS Number : 2168Z
Tiziana Life Sciences PLC
09 January 2020
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana Reports Phase 1 Clinical Data Demonstrating Oral
Treatment with Foralumab, a Fully Human Anti-CD3 Monoclonal
Antibody, is Well-tolerated in Healthy Volunteers
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
New York/London, 9 January 2020 - Tiziana Life Sciences plc
(Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology
company focused on innovative therapeutics for inflammatory
diseases and cancers, is pleased to report completion of a Phase 1
clinical study of Foralumab, a fully human anti-CD3 monoclonal
antibody ("mAb"), in healthy subjects. The proprietary oral
formulation, comprising the lyophilized and stabilized free-flowing
powder of formulated Foralumab encapsulated in an enteric-coated
capsule, was well-tolerated at all doses tested and there were no
drug-related safety issues even at the highest dose of 5 mg in this
trial.
This Phase 1 trial, conducted at the Brigham and Women's
Hospital, Harvard Medical School, Boston, MA, USA, was a
single-site, double-blind, placebo-controlled, single ascending
dose ("SAD") study in healthy subjects in which Foralumab was
orally administered at 1.25, 2.5 and 5.0 mg per dose as
enteric-coated capsules. Each cohort comprised of 4 subjects, of
whom 3 received Foralumab treatment and 1 received a placebo
capsule. All subjects completed the trial without any safety
concerns at any of the doses.
It has previously been shown that orally administered Foralumab
to NOD/SCID IL2<GAMMA>c-/- mice (which have human immune
systems) with skin xenografts was well-tolerated up to 15 ug/day
(n=20; human equivalent dose of 3.66 mg/dose in a 60 kg human) for
5 days then weekly, prevented skin xenograft rejection
indefinitely. Clinical studies conducted by other researchers have
also shown that oral administration of OKT3, a murine anti-CD3 mAb,
was well-tolerated up to 5 mg/day for 5 days to healthy subjects,
to patients with nonalcoholic steatohepatitis ("NASH") for 30 days
and to hepatitis C virus ("HCV") non-responders for 30 days. Data
from a recently completed clinical study indicated that oral
administration of OKT3 was well tolerated at 1 mg/day for 30
consecutive doses in patients with moderate-to-severe ulcerative
colitis. Importantly, the treatment resulted in clinical responses
in 3 out of 6 patients, including one patient with a complete
clinical response.
"This is the first-ever study demonstrating that orally
administered Foralumab is well-tolerated at all doses up to 5.0
mg/dose. This ground breaking study opens a novel avenue for future
development of oral mAb therapeutics " commented Dr. Howard L.
Weiner, a member of the scientific advisory board of Tiziana Life
Sciences. Recently, we also successfully demonstrated that nasally
administered Foralumab is not only well-tolerated but also produced
the desirable immunological responses. He added that "both oral and
nasal administration routes are physiologic approaches to stimulate
the mucosal immune system to induce disease modifying
benefits."
"We are very pleased with the tolerability of both oral and
nasally administered Foralumab" added Dr. Tanuja Chitnis, Professor
of Neurology at Harvard Medical School, and study Principal
Investigator ("PI").
"Successful completion of this study is a significant milestone
to validate our proprietary technologies of oral and nasal
administration of mAbs, which we believe could potentially be
transformational for future development of mAbs therapeutics. We
are excited to note that oral administration was well-tolerated and
that the treatment did not result in severe toxicities that are
commonly observed with intravenous (IV) administration of anti-CD3
mAbs. These findings provide the scientific rationale for our core
technologies of oral and nasal formulations of mAb therapeutics,
said Dr. Shailubhai, CEO & CSO of Tiziana Life Sciences.
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, demonstrated a 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
improved 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. 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 oral and nasal 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). Administration of anti-CD3
antibody orally in SLJ mice was shown to suppress autoimmune
encephalomyelitis and 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 oral and nasal anti-CD3 mAbs as a new approach to
treat progressive forms of multiple sclerosis and other types of
chronic CNS inflammation. Additionally, mucosal administered
anti-CD3 mAbs suppressed lupus in lupus-prone mice ("BWF1") by
inducing IL-10 and TGF-<BETA> ("Transforming Growth Factor")
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 nonalcoholic steatohepatitis
("NASH"), ulcerative colitis, multiple sclerosis, type-1 diabetes
("T1D"), Crohn's disease, 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.
Contacts:
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser) + 44 (0)20 7213
Liam Murray / Jo Turner 0883
Shore Capital (Broker)
Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125
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END
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