Tiziana Announces Initiation of Phase 1 Clinical Trial with Nasal Administration of Foralumab, a Fully Human Anti-Cluster Def...
29 November 2018 - 2:24AM
Business Wire
A breakthrough approach for treatment of neurodegenerative
diseases such as progressive multiple sclerosis
Tiziana Life Sciences plc (“Tiziana” or the “Company”) (Nasdaq:
TLSA / AIM: TILS), a UK biotechnology company that focuses on the
discovery and development of novel molecules to treat human disease
in oncology and immunology, previously announced that it had
submitted an Investigational New Drug (IND) application on 1 June
2018 to the U.S. Food and Drug Administration (FDA). Following
approval of the IND application by the FDA, the Company announces
that a first-in-human Phase 1 clinical trial in healthy volunteers
has been initiated at the Brigham and Women’s Hospital, Harvard
Medical School, Boston, Massachusetts, USA.
“Foralumab in a stable formulation will be nasally administered
by a dose-escalating regimen starting at 10, 50 and 250 µg/day,
using a nasal spray device. This Phase 1 clinical trial in healthy
volunteers will evaluate safety and tolerability of Foralumab. The
clinical protocol also includes evaluation of unique biomarkers of
immunomodulation, induction of T regulatory cells (Tregs) and
anti-inflammation to assess therapeutic potential of the
treatment.
Nasal administration with anti-CD3 mAbs induces Tregs in the
cervical lymph node that then cross the blood brain barrier and
provide an interleukin-10 dependent anti-inflammatory signal to
downregulate the activated glial cells in brain and return them to
their normal homeostatic state. Thus, this is an exciting,
innovative and physiological approach to stimulate the mucosal
immune system to induce disease modifying Tregs”, commented Dr.
Howard Weiner, a member of scientific advisory board of
Tiziana.
Intranasal delivery of therapeutic anti-CD3 mAb is a game
changer that employs immune mechanisms overcoming the obstacle of
the blood brain barrier and it has the potential as entirely new
class of therapies for treatment of a wide range of human
diseases”, said Gabriele Cerrone, Chairman and founder of
Tiziana.
“Filing this IND for nasal administration of Foralumab is a
first and major milestone towards the Company’s objective to
develop innovative therapies with alternative routes of
administration whilst maximizing efficacy.
We also plan to submit a similar IND for a Phase 1b clinical
trial with encapsulated and enteric-coated formulation of Foralumab
in healthy volunteers to evaluate safety and tolerability in the
first quarter of 2019. A well-established panel of blood biomarkers
will be examined to assess potential of orally administered
Foralumab for treatment of autoimmune and inflammatory diseases
such as non-alcoholic fatty liver disease (NASH) and Crohn’s
disease”, commented Kunwar Shailubhai, CEO and CSO of Tiziana.
About Dr. Howard Weiner
Dr. Howard L. Weiner is the Robert L. Kroc Professor of
Neurology at the Harvard Medical School, Director and Founder of
the Partners Multiple Sclerosis (MS) Center and Co-Director of the
Ann Romney Center for Neurologic Diseases at Brigham & Women's
Hospital in Boston. He has pioneered immunotherapy in MS and has
investigated immune mechanisms in nervous system diseases including
MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and
brain tumors. He has also pioneered the investigation of the
mucosal immune system for the treatment of autoimmune and other
diseases and the use of anti-CD3 to induce Tregs for the treatment
of these diseases.
About Harvard Medical Centre
Brigham and Women's Hospital (BWH) is located adjacent to
Harvard Medical School, of which it is the second largest teaching
affiliate. It is the largest hospital of the Longwood Medical and
Academic Area in Boston, Massachusetts, USA. With Massachusetts
General Hospital, it is one of the two founding members of Partners
HealthCare, the largest healthcare provider in Massachusetts. BWH
conducts the second largest hospital-based research program in the
world, with an annual research budget of more than $630 million.
Pioneering milestones include the world's first successful heart
valve operation and the world's first solid organ transplant.
About Autoimmune Diseases and Foralumab
Autoimmune diseases constitute a major medical problem and
include diseases such as multiple sclerosis, type 1 diabetes,
rheumatoid arthritis and inflammatory bowel disease. Other diseases
that have inflammatory components include diseases such as NASH,
atherosclerosis and stroke. The induction of regulatory cells at
mucosal surfaces by the oral or nasal administration of antigens
has been shown to treat a large variety of autoimmune and
inflammatory diseases in animal models with minimal toxicity.
Foralumab was developed by Novimmune and was acquired by Tiziana.
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 IL2γc-/-) developed in Dr.
Kevan Herold’s laboratory, 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.
About Tiziana Life Sciences
Tiziana 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 mAbs in clinical development in
the world. This compound has potential application in a wide range
of autoimmune and inflammatory diseases, such as nonalcoholic
steatohepatitis (NASH), primary biliary cholangitis (PBS),
ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D),
inflammatory bowel disease (IBD), psoriasis and rheumatoid
arthritis, where modulation of a T-cell response is desirable.
For more information go
to http://www.tizianalifesciences.com
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version on businesswire.com: https://www.businesswire.com/news/home/20181128005504/en/
Contacts:Tiziana Life Sciences plcGabriele
Cerrone, Chairman and founder+44 (0)20 7493 2853Cairn Financial
Advisers LLP (Nominated adviser)Liam Murray / Jo Turner+44
(0)20 7213 0883Stockdale Securities (Nominated
brokers)Antonio Bossi / Andy Crossley+44 (0)20 7601 6125
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