- Milciclib was well tolerated and no drug related deaths were
reported
- 28 out of 31 treated patients were evaluable, with 14
patients completing the 6-month study duration
- 9 patients continued treatment under compassionate use, of
which 5 are currently continuing with treatment
THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT
IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS
STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON
PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION
SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC
DOMAIN.
Tiziana Life Sciences plc
(the "Company", "Tiziana Life Sciences" or
"Tiziana")
Tiziana Life Sciences plc (NASDAQ: TLSA / AIM: TILS), a
biotechnology company focusing on the discovery and development of
innovative therapeutics for inflammation and oncology indications,
today announced preliminary topline clinical data from a Phase 2a
trial of Milciclib as a monotherapy in patients with advanced
hepatocellular carcinoma (HCC), the most common form of liver
cancer. The primary endpoint of the study was overall safety. Under
compassionate use, a few patients continued with total treatment
for up to 16 months. Overall, treatment with Milciclib was
well-tolerated and no drug-related deaths were recorded. Secondary
endpoints of efficacy including progression-free survival (PFS) and
time to progression (TTP) are currently being evaluated and will
subsequently be reported.
This Phase 2a trial with Milciclib monotherapy was a
multi-centered, single-arm, repeated-dose (100 mg once daily; 4
days on/3 days off every 4 weeks; defining each cycle), 6-month
duration study to evaluate the safety, tolerability and anti-tumor
activity of Milciclib in sorafenib-refractory or intolerant
patients with unresectable or metastatic advanced HCC. This trial
enrolled 31 patients in Italy, Greece, and Israel.
Among the 28 evaluable patients, 14 completed the 6-month
duration study. Oral treatment with Milciclib was well-tolerated
with manageable toxicities. The most frequent adverse events such
as diarrhea, ascites, nausea, fatigue, asthenia, fever, ataxia,
headache, and rash were manageable.
9 out of the 14 patients, after completing the 6-month trial
period, requested to continue the treatment under compassionate use
and were approved by their respective ethical committees. Four of
the patients received Milciclib for a total of 9, 11, 13 and 16
months. The remaining 5 patients are continuing treatment with
Milciclib are at 8th, 9th, 9th, 9th and 11th month currently.
Objective tumor assessments according to the modified Response
Evaluation Criteria in Solid Tumors (mRECIST) guideline and the
conventional RECIST 1.1 criteria are being conducted by Independent
Central Review and data will be available in September 2019.
“We are very pleased with the clinical activity and tolerability
of Milciclib in these advanced cases of HCC. It is an important
milestone to move forward with further clinical development of
Milciclib either as a single agent or in combination with other HCC
drugs,” said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana. These
data are consistent with the earlier reported long-term safety and
clinical activity of Milciclib in thymic carcinoma, thymoma1
and other solid cancers2.
The global market for liver cancer drugs is estimated to reach
$1.47 billion by 2022. The current standard of care drugs is not
entirely satisfactory due to low response rates and severe
toxicities. Importantly, patients often become resistant or
unresponsive to the treatment. Milciclib works through a unique
mechanism of action and the Company therefore believes it may have
the potential for long-term efficacy with a good safety profile in
a larger subset of patients.
The person who arranged for the release of this announcement on
behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of
Tiziana.
Cited References
1. Besse, B., Garassino, M., Rajan, A., Novello, S., Mazieres,
J., Weiss, G., Kocs, D., Barnett, J, Davite, C, Crivori, P and G.
Giaccone. Efficacy of milcicilib (PHA-848125AC), a pan-cyclin D
-dependent kinase inhibitor in tow phase II studies with Thymic
carcinoma and B3 thymoma patients. (2018) J. Clin. Onc 36 (15
suppl): 8519
2. Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. (2017).
Phase I dose-escalation study of Milciclib in combination with
gemcitabine in patients with refractory solid tumors. Cancer
Chemother Pharmacol. 79:1257-1265.
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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.
About HCC
HCC is the fifth most common cancer and the third highest cause
of cancer mortality worldwide. In 2007, the approval by the
European Medical Agency and U.S. Food and Drug Administration of
Sorafenib (Nexavar®), an inhibitor of several receptor tyrosine
kinases, 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, with a response rate less than
3%, an improvement in median survival of 2-3 months and
drug-related symptoms that are not ordinary. More recently,
lenvatinib (Lenvima ®), another multi-tyrosine kinase inhibitor was
also approved for first line treatment of HCC. The complex
multi-factorial etiology of HCC warrants a need for systemic
therapies that target different signaling cascades to provide
improved efficacy and safety 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, CDK2, 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 associated with development of
resistance towards chemotherapies. In a Phase 1 study, oral
treatment with Milciclib was 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. Additionally, milciclib met its primary
endpoint in two separate Phase 2 multi-center clinical trials
(CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in
thymic carcinoma and thymoma patients.
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 2
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190721005026/en/
Tiziana Life Sciences plc Gabriele Cerrone, Chairman and
founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser) Liam
Murray / Jo Turner +44 (0)20 7213 0883
Shore Capital (Broker) Andy Crossley / Antonio Bossi +44
(0)20 7601 6125
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