Tiziana Life Sciences PLC A Proprietary Oral Formulation of Foralumab (8848P)
September 06 2017 - 2:00AM
UK Regulatory
TIDMTILS
RNS Number : 8848P
Tiziana Life Sciences PLC
06 September 2017
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Development of a Proprietary Oral Formulation of Foralumab, a
Fully Human Anti-CD3 mAb, for use in an Upcoming Phase 2a Clinical
Trial in NASH
-- Successfully developed a novel formulation enabling oral
immunotherapy with foralumab for NASH and other autoimmune
diseases
-- The proprietary technology underlying the oral formulation is
a significant advancement in the field of oral immunotherapy with
human monoclonal antibodies (mAbs)
London, September 6, 2017 - Tiziana Life Sciences plc (AIM:
TILS, the "Company"), the clinical stage biotechnology company
developing targeted drugs for cancer and autoimmune diseases,
announces development of a novel, proprietary, oral formulation of
foralumab, a fully human anti-CD3 monoclonal antibody (mAb), to be
used in upcoming clinical studies in patients with non-alcoholic
steatohepatitis (NASH) and other inflammatory diseases. This is the
first-ever development of an oral formulation suitable for therapy
with foralumab (NI-0401).
"Oral immunotherapy with an anti-CD3 mAb is expected to be a
preferred approach for targeted immunomodulation without eliciting
immunosuppression throughout the body. However until now, oral
administration has not been pursued due to the expectation of mAbs
being inactivated by the harsh conditions in the gastrointestinal
tract," commented Gabriele Cerrone, Chairman of Tiziana Life
Sciences. "The development of this proprietary oral formulation is
a breakthrough in novel dosing formulation and we believe that this
technology may have broad additional therapeutic utility with other
mAbs."
"Oral administration with biologics such as mAbs is a potential
game changer for immunotherapies, enhancing drug safety while
potentiating immunomodulation to provide clinical responses," said
Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences. "Recently
we demonstrated, using humanized mice models, that orally
administered foralumab is biologically effective to produce
immunomodulatory activity(1) . Thus, successful development of the
oral formulation of foralumab is a major milestone, and it opens up
a novel avenue for treatment of NASH and other autoimmune
diseases."
Cited Reference
1. Oral treatment with foralumab, a fully human anti-CD3
monoclonal antibody, prevents skin xenograft rejection in humanized
mice. Ogura M1, Deng S, Preston-Hurlburt P, Ogura H, Shailubhai K,
Kuhn C, Weiner HL, Herold KC.
Clin Immunol. 2017 Jul 21. pii: S1521-6616(17)30342-X.
doi:10.1016/j.clim.2017.07.005. [Epub ahead of print]
About NASH
Non-alcoholic fatty liver disease (NAFLD) is one of the causes
of fatty liver, which occurs when fat is deposited (steatosis) in
the liver due not related to alcohol use. It affects 30% of the
western world population. Non-alcoholic steatohepatitis (NASH) is a
severe type of NAFLD. NASH occurs when the accumulation of liver
fat is accompanied by inflammation and cellular damage. The
inflammation can lead to fibrosis (scarring) of the liver and
eventually progress to cirrhosis, portal hypertension, liver cancer
and liver failure. According to a market research report
Nonalcoholic Steatohepatitis Treatment Market 2015-2025 published
by iHealthcareAnalyst, Inc., the global nonalcoholic
steatohepatitis treatment market is estimated to reach USD 19.5
Billion in 2025, expanding at a current annual growth rate of 10.0%
from 2016 to 2025. Currently there is no approved therapy for
NASH.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that
focuses on the discovery and development of novel molecules that
treat human disease in oncology and immunology. The Company is
focused on its lead compound, milciclib, a molecule which blocks
the action of specific enzymes called cyclin-dependent kinases
(CDK) involved in cell division as well as a number of other
protein kinases. Milciclib is currently completing phase II
clinical trials for epithelial thymic carcinoma and/or thymoma in
patients previously treated with chemotherapy and has filed an IND
to enroll patients in an exploratory trial in Hepatic Cellular
Carcinoma (HCC). The Company is also in clinical development of
foralumab. Foralumab is the only fully human engineered anti-human
CD3 antibody in clinical development. This phase II compound has
potential application in a wide range of autoimmune and
inflammatory diseases, such as 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
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
Contacts
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7493 2853
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Jo Turner +44 (0)20 7213 0880
Beaufort Securities Limited (Broker)
Zoe Alexander +44 (0)20 7382 8300
FTI Consulting
Simon Conway / Natalie Garland-Collins +44 (0)20 3727 1000
This information is provided by RNS
The company news service from the London Stock Exchange
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