TIDMTILS
RNS Number : 1999O
Tiziana Life Sciences PLC
16 May 2018
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana Life Sciences Announces Interim Analysis Data from an
Ongoing Phase 2a Trial of Milciclib Safety and Tolerability in
Sorafenib-refractory or -intolerable, Unresectable or Metastatic
Hepatocellular Carcinoma (HCC) Patients
Treatment with Milciclib (100 mg once daily; 4 day On/3 day Off
every four weeks defining each cycle) was well-tolerated for up to
6 cycles in this population of HCC patients
London, 16 May, 2018 - Tiziana Life Sciences plc (AIM: TILS), a
clinical stage biotechnology company developing targeted drugs for
cancer and inflammatory diseases, today announces that the
independent data monitor committee (IDMC) completed a second,
interim analysis of tolerability data from the first eleven treated
patients and recommended expansion of the initial cohort to
continue enrolment of an additional 20 patients to complete the
trial.
This phase 2a multi-centre and multi-country clinical trial
(CDKO-125A-010) in sorafenib-refractory or -intolerable patients
with unresectable or metastatic HCC is being conducted in Greece,
Italy and Israel. Since, this was the first trial with milciclib in
HCC patients, a second, interim analysis was scheduled following
completion of treatment for the first 11 patients before initiating
enrolment of the next 20 patients. Thus, demonstration of good
tolerability with acceptable incidence of serious adverse events is
an important milestone to initiate a phase 2b trial evaluating
combination of milciclib with sorafenib (NexavarÃ’; Bayer Germany
(BAYN.GR)) in HCC patient.
Major findings were as follows:
-- Milciclib treatment was well-tolerated with manageable
drug-related toxicities. The IDMC concluded that there were no
major signals of tolerability concerns and therefore favours
proceeding to expand enrolment.
-- Four patients have completed the study per protocol (6 cycles
of treatment in 6 months). Two of these patients and their care
provider opted to continue receiving milciclib at full dose as part
of compassionate use. A third patient is awaiting ethical committee
(EC) approval.
Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented:
"Establishment of tolerability of milciclib as a single agent in
HCC patients is a key pre-requisite to initiate the phase 2b trial
to evaluate dosing, tolerability and clinical activity of milciclib
in combination with sorafenib (NexavarÃ’; Bayer Germany) in HCC
patients.
Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences,
commented: "we are pleased with the conclusion of IDMC that
milciclib treatment showed no major signals of tolerability
concerns in sorafenib-refractory or -intolerable HCC patients.
These findings are consistent with the findings reported earlier on
the long-term tolerability and clinical activity of milciclib in
thymic carcinoma, thymoma(1) and other solid cancers(2) . Results
from these clinical studies strongly warrant further clinical
development of milciclib for treatments of HCC and other
cancers".
Cited References
1. Press Release on announcement of clinical data in thymoma and thymic carcinoma.
www.tizianalifesciences.com .
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
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 (CDKs) such as CDK1, 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 thymic
carcinoma, pancreatic carcinoma and colon cancer.
About Sorafenib
Sorafenib (co-developed and co-marketed by Bayer and Onyx
Pharmaceuticals as Nexavar) is a small molecular multi tyrosine
kinase inhibitor drug approved for the treatment of primary kidney
cancer (advanced renal cell carcinoma), advanced primary liver
cancer (HCC), and radioactive iodine resistant advanced thyroid
carcinoma. Treatment with sorafenib induces autophagy, which may
suppress tumor growth. However, autophagy can also cause drug
resistance.
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-CD3 antibody in clinical development. This
phase 2 compound has potential application in a wide range of
autoimmune and inflammatory diseases, such as non-alcoholic
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.
The content of this announcement has been reviewed and approved
for publication by Dr Kunwar Shailubhai, CEO & CSO of the
Company.
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
This information is provided by RNS
The company news service from the London Stock Exchange
END
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