TIDMTILS
RNS Number : 5978X
Tiziana Life Sciences PLC
05 May 2021
Tiziana Announces Strategic Initiative with Takanawa Japan K.K.,
Pharma Team, to Identify a Partner in Japan and Other Asian
Countries for Further Clinical Development of Milciclib in Patients
with Advanced Hepatocellular Carcinoma.
-- Objective of this partnership with Takanawa Japan K.K.,
Pharma Team, is to identify a strategic partner in Japan for
further development of Milciclib either alone or in combination
with a tyrosine kinase inhibitor (TKI) for treatment of advanced
HCC patients in Asian countries where prevalence of HCC is high,
and the available therapeutic options are not entirely
satisfactory.
-- Milciclib, a broad-spectrum cyclin dependent kinase (pan-CDK)
inhibitor, has successfully completed eight phase 1 and phase 2
trials in thymic carcinoma, thymoma and hepatocellular carcinoma
(HCC), showing tolerability and positive clinical responses.
-- Clinical data from Phase 2a trial, presented at the American
Society of Clinical Oncology 2020, indicated that orally
administered Milciclib in Sorafenib-resistant patients was
well-tolerated, and it produced positive clinical responses.
-- Tiziana was recently awarded a patent to use Milciclib in
combination with a TKI or other drugs for treatment of HCC and
other cancers.
New York/London, 5 May 2021 - Tiziana Life Sciences plc (Nasdaq:
TLSA / LSE: TILS) ("Tiziana" or the "Company"), a biotechnology
company focused on innovative therapeutics for oncology,
inflammation, and infectious diseases, announces that it has
executed an agreement with Takanawa Japan K.K, Pharma Team,
(Takanawa) for a strategic business development plan to Identify a
clinical partner in Japan and other Asian countries for further
clinical development of Milciclib for treatment in advanced
hepatocellular carcinoma (HCC) patients. HCC is the most common
type of liver cancer and affects approximately 200,000 people per
year.
Previously, Tiziana successfully completed a Phase 2 clinical
trial with orally administered Milciclib in sorafenib-resistant or
intolerant HCC patients. The clinical data, presented at the
American Society of Clinical Oncology (ASCO) (1) , demonstrated
that the treatment was well-tolerated and produced clinical
activity. Recently, a patent covering the use of Milciclib in
combination with a tyrosine kinase inhibitor (TKI) or other drugs
was granted (2) . The granted claims provide complete freedom to
further develop a combination of Milciclib with an approved TKI for
treatment of patients with advanced HCC or other cancers. Because
the prevalence of HCC in Asian countries is large and there are no
satisfactory therapeutic options for treatment of advanced HCC in
Asian countries, the strategic initiative with Takanawa is
particularly important to further develop Milciclib for the
treatment of advanced HCC patients.
"We are pleased and excited to work with Takanawa, a firm with a
distinguished history of business development activities in the
Japanese pharmaceutical industry, to identify an appropriate
partner in Japan for further clinical development of Milciclib. We
believe the positive clinical activity in advanced HCC and other
cancers warrant immediate further development in Japan and other
Asian countries where the prevalence of this cancer is relatively
high, and the current available therapies are not entirely
satisfactory" said Dr. Kunwar Shailubhai, CEO and CSO of Tiziana
Life Sciences.
"We are honored to get the opportunity to identify a strategic
partner for Milciclib for the treatment of advanced hepatocellular
carcinoma (HCC) patients. Tiziana has managed to develop a product
that will really have an impact and save lives since HCC affects
about 200,000 people in the world and 40,000 people in Japan every
year. Therefore, we hope to receive a lot of interest from leading
pharmaceutical companies " said Dr. Kaoru Nozu, Executive
Representative of the Takanawa Pharma Team.
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.
Cited References:
1. Abstract #298561: Phase 2a Safety and Efficacy of Milciclib,
a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable,
Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma
Patients.
First Author: Erica Villa, MD., et al.
2. US Patent (10,758,541 B2 (Inventor: Shailubhai) Issue Date: September 1, 2020
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 (THE "EUWA")) ("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.
About Milciclib
Milciclib (PHA-848125AC) is a small molecule inhibitor of
several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and
CDK7. CDKs are serine threonine kinases that play crucial roles in
progression of the cell cycle from G(1) to S phase. Overexpression
of CDKs and other downstream signalling pathways that regulate cell
cycles have been frequently found to be associated with development
of resistance towards chemotherapies. In a phase I study, oral
treatment with Milciclib was found to be well-tolerated and the
drug showed promising clinical responses in patients with advanced
solid malignancies such as in NSCLC, pancreatic and colon cancer,
thymic carcinoma and thymoma.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA &
UK LSE: 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.
About Takanawa
Takanawa is a global consulting, development and trading
company, with a very strong Pharma Team. In that area Takanawa
develops its own pharma projects, advises cross border pharma
transactions, licensing, and alliances. Takanawa also supports
companies entering the Japanese and Asian market as well as
Japanese companies to enter overseas markets. Takanawa's seasoned
pharma specialists are both high level scientists with research
background from USA (Bethesda), NCI and NIH, and from Japan, the
Japanese Foundation for Cancer Research, Japan National Institute
of Radiological Medicines, Tokyo University and Kyoto University,
as well as experienced business people from leading pharma
companies like Sanofi, Kyowa Kirin, Yakult and Actavis, with an
extensive track record and network. Examples of known oncology
products Takanawa specialists have been involved with in their
previous positions are oxaliplatin, camptothecin (irinotecan),
G-CSF, docetaxel, epirubicin, gemcitabine, vinorelbine and 5-FU.
For further information please see www.takanawa.is/pharmaceuticals
.
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.
407-491-4498
dave@redchip.com
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