Tiziana Life Sciences PLC Milciclib synergistic activity presented at AASLD
October 16 2018 - 2:01AM
RNS Non-Regulatory
TIDMTILS
Tiziana Life Sciences PLC
16 October 2018
Tiziana Life Sciences Announces that it will be presenting data
from animal studies demonstrating the potential synergistic
activity of Milciclib with Tyrosine Kinase Inhibitors to treat
Hepatocellular Carcinoma (HCC) at the American Association for the
Study of Liver Diseases (AASLD) Meeting (9(th) to 13(th) November
2018 in San Francisco)
London, 16 October 2018 - Tiziana Life Sciences plc (AIM: TILS),
a clinical stage biotechnology company developing targeted drugs
for cancer and inflammatory diseases, will present results from
preclinical studies demonstrating synergistic activity of milciclib
with sorafenib (NexavarÒ) to suppress tumor growth in an orthotopic
mouse model of HCC. Additional preclinical studies will be
presented which also demonstrated synergism between Milciclib and
other tyrosine kinase inhibitors (TKIs) such as Regorafenib
(StivargaÒ) and Lenvatinib (LenvimaÒ). The presentation will take
place at the American Association for the Study of Liver Diseases
(AASLD) Meeting in San Francisco on 9-11 November 2018.
The details of the presentation are:
Poster #1543 entitled "Oral Treatment with Milciclib Either
Alone or in Combination with Sorafenib Inhibited Tumor Growth in an
Orthotopic Model of Hepatocellular Carcinoma" will be presented at
the Poster Session III on November 11, 2018.
The data results from pre-clinic studies in mouse models which
will inform future research but the information to be presented is
an extension of previously announced research and does not, in the
view of the Company and its directors, constitute material data
requiring dissemination via a regulatory news service. According
this information is being released via RNS Reach to inform
interested parties of the direction and results of our continuing
research activity.
MAJOR HIGHLIGHTS OF THE DATA
-- Oral treatment with milciclib (30mg/kg/day) in combination
with sorafenib (20mg/kg/day) produced synergistic effect on
reduction of HCC-tumor growth in an orthotopic animal model. Since,
the doses of milciclib and sorafenib used were sub-optimal, it is
possible that the combination treatment at sub-optimal doses may
reduce the toxicities of sorafenib or other TKIs.
-- While treatment with milciclib as a single agent
significantly suppressed growth in cell cultures as well as in
animal models, it also exhibited strong synergistic anti-HCC
effects with TKIs such as sorafenib, regorafenib and lenvatinib in
other pre-clinical studies
-- Mechanism of action studies suggest that milciclib exhibits
broad-spectrum anti-HCC activity through a different mechanism from
TKIs to produce the pronounced synergism.
"We reported earlier that oral treatment with Milciclib was
found to be well-tolerated and it achieved both primary and
secondary clinical endpoints in two separate phase 2 trials in
thymic carcinoma and thymoma. The new pre-clinical research data
demonstrating synergism with TKIs is exciting and suggests the
potential of Milciclib in combination with one of these approved
TKIs to develop a safe and an improved treatment option for HCC
patients" said Gabriele Cerrone, Chairman of Tiziana Life
Sciences
The complex multi-factorial etiology of HCC warrants an
immediate need for drugs with different mechanisms that may produce
improved efficacy and safety. The data we have announced from the
interim analysis of the ongoing phase 2a clinical study of orally
administered milciclib in sorafenib-resistant patients suggests
that the treatment is well-tolerated and seems to provide clinical
benefits to these patients. We are pleased to see that milciclib
produces strong synergistic anti-HCC activity in preclinical
studies as these data are important milestones to move forward in
our evaluation the potential of Milciclib in combination with one
of the approved TKIs to improve safety, efficacy and clinical
response rate in HCC patients" said Kunwar Shailubhai, CEO &
CSO of Tiziana Life Sciences.
About Hepatocellular Carcinoma
Hepatocellular cancer is the 5th most common cancer and the 3rd
cause of cancer mortality worldwide. In 2007 the approval by the
European Medical Agency (EMA) and Food and Drug Administration
(FDA) of sorafenib in HCC represented the first systemic therapy
for improving outcome in patients unsuitable for loco-regional and
surgical therapies and created a new standard of treatment for the
disease. However, although significant in respect to placebo, the
benefits of sorafenib are modest; the response rate is less than
3%, the improvement in median survival is 2-3 months and the
drug-related symptoms are not ordinary. Therefore, more effective
systemic therapy is required for both naive patients presenting
with unresectable, advanced stage and those who suffer recurrence
after curative treatments (resection, ablation and
transplantation).
About Milciclib
Milciclib (PHA-848125AC) is a small molecule inhibitor of
several cyclin dependent kinases such as CDK1, CDK4, CDK5 and CDK7.
CDKs are serine threonine kinases that play crucial roles in
progression of the cell cycle from G1 to S phase. Overexpression of
CDKs and other downstream signaling 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.
A phase 2a multi-centre and multi-country clinical trial
(CDKO-125A-010) in sorafenib-refractory or -intolerable patients
with unresectable or metastatic HCC is currently being conducted in
Greece, Italy and Israel.
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 II
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.
About AASLD
American Association for the Study of Liver Diseases (AASLD) is
the leading organization of scientists and health care
professionals committed to preventing and curing liver disease. It
was founded in 1950 by a small group of leading liver specialists
to bring together those who had contributed to the field of
hepatology. AASLD has grown to an international society responsible
for all aspects of hepatology. The Liver Meeting(R), is attended by
more than 9,500 physicians, surgeons, researchers, and allied
health professionals from around the world. (Source: AASLD
Website).
For more information go to
http://www.tizianalifesciences.com
Contacts
Tiziana Life Sciences plc +44 (0)20 7493 2853
Gabriele Cerrone, Chairman and founder
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END
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