Tiziana Life Sciences Announces Approval of a Phase II Clinical Trial Protocol for Milciclib in Patients with Hepatocellular ...
April 24 2017 - 1:00AM
Business Wire
In mouse models of HCC, oral administration
with milciclib effectively suppressed tumour growth
Tiziana Life Sciences plc (AIM: TILS), a clinical stage
biotechnology company developing targeted drugs for cancer and
autoimmune diseases, today announces the approval in Israel of a
phase II clinical trial protocol for testing milciclib, a novel
inhibitor of cell cycle dependent kinases (CDKs), in patients with
refractory hepatocellular carcinoma (“HCC”). A similar clinical
trial protocol has been submitted for approval in Italy, Turkey and
Greece. The primary objective of these multi-centered,
multi-country and dose-ranging phase IIa clinical studies is to
evaluate the safety of milciclib in HCC patients who fail to
respond or are intolerant to the existing standard of care
treatment. First patient enrollment is expected next month and top
line data from the trial is expected by Q3 2018.
In previous clinical studies, oral treatment with milciclib was
found to be safe and well-tolerated in patients with refractory
solid tumours, thymoma and thymic cancers. Data from animal studies
has demonstrated that oral administration with milciclib
effectively suppressed tumour growth in mouse models of HCC.
Although the precise mode of action is not clearly understood, the
preclinical studies conducted strongly suggest that milciclib acts
primarily through downregulation of microRNA (miR) 221 and 222,
which are known to be associated with hepatocarcinogenesis.
Overexpression of miR-221 and miR-222 is also believed to be
associated with development of resistance to sorafenib (Nexavar®)
in HCC patients
Gabriele Cerrone, Chairman of Tiziana commented: "HCC is a real
unmet medical need due to its growing incidence and lack of
effective therapy. It is the fifth most common cancer worldwide and
the second most common cause of death from cancer worldwide. We
strongly believe that milciclib has the potential to be developed
either as a monotherapy or in combination with sorafenib for
treatment of HCC.”
Dr. Yaron Ilan, Director of the Department of Medicine at Hebrew
University Hadassah Medical Center, Israel and Chief Medical
Officer of Tiziana added: “The prognosis for liver cancer is very
poor due to lack of effective therapy. We were very encouraged with
recent pre-clinical findings and are now moving forward to conduct
a phase II clinical trial in HCC patients with milciclib in
patients that failed to respond to the standard of care therapy. We
believe that milciclib holds promise as an effective anti-cancer
treatment with a high safety profile."
About HCC
Hepatocellular carcinoma is the fifth most common cancer in men
and the ninth in women. Additionally, it is the fifth most common
cancer worldwide and the second most common cause of death from
cancer worldwide.1 The tumour is associated with chronic hepatitis
B and chronic hepatitis C infections, as well as with nonalcoholic
steatohepatitis. The prognosis for liver cancer is very poor due to
lack of effective therapy.
About Milciclib
Milciclib (PHA-848125AC) is a small molecule inhibitor of
several cyclin dependent kinases (CDKs) 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. Oral treatment with milciclib
was found to be effective in reducing tumour growth in animal
models of HCC, possibly through downregulation of miR-221 and
miR-222. 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
thymic carcinoma, pancreatic carcinoma and colon cancer.
About Yaron Ilan, MD
Prof. Yaron Ilan is the Director of the Department of Medicine
at the Hadassah-Hebrew University Medical Center in Jerusalem
Israel and served as the Vice Dean of the Hebrew
University-Hadassah Medical School. He has pioneered the
development of oral immunotherapy for HCC, NASH, diabetes, and
inflammatory bowel diseases. He developed several products which
target the immune system of the gastrointestinal tract as a mean
for alleviating immune-mediated disorders without the need for
immunosuppression. He holds over 50 patents for discoveries based
on his research mainly in oral immunotherapy and mucosal
immunology. His clinical interests are in the management of NASH
and diabetes by targeting the inflammation-associated with these
diseases by using products with high safety profile enabling their
chronic use. He is involved in multiple clinical trials using oral
immunotherapy-based compounds.
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. 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 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
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
1 http://www.who.int/mediacentre/factsheets/fs297/en/
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version on businesswire.com: http://www.businesswire.com/news/home/20170423005055/en/
Tiziana Life Sciences plcGabriele Cerrone, Chairman and
founder+44-(0)20-7493-2853orCairn Financial Advisers LLP
(Nominated adviser)Liam Murray, +44-(0)20-7213-0883orBeaufort
Securities Limited (Broker)Saif Janjua,
+44-(0)20-7382-8300orFTI ConsultingSimon Conway / Natalie
Garland-Collins+44-(0)20-3727-1000
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