Tiziana Life Sciences PLC Milciclib Phase 2a Trial Update (7502Y)
08 December 2017 - 6:00PM
UK Regulatory
TIDMTILS
RNS Number : 7502Y
Tiziana Life Sciences PLC
08 December 2017
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana Life Sciences Announces Safety of Milciclib in a Phase
2a Trial in Unresectable or Metastatic Hepatocellular Carcinoma
(HCC) Patients
Demonstration of safety, a pre-requisite to initiate a Phase 2b
trial evaluating combination of Milciclib with sorafenib (NexavarÒ;
Bayer Germany (BAYN.GR)) in HCC patients, is an important
milestone
London, 08 December, 2017 - 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 interim
analysis of the safety and pharmacokinetic data from the first six
patients and concluded that treatment with Milciclib was safe and
well-tolerated with no drug-related serious adverse events (SAEs)
in patients with unresectable or metastatic HCC. The IDMC
recommended continuing with the trial.
-- This Phase 2a multi-center and multi-country clinical trial
(CDKO-125A-010) in patients with unresectable or metastatic HCC was
conducted in Israel, Italy and Greece. Since, this was the first
trial with Milciclib in HCC patients, an interim analysis was
scheduled to ensure safety of patients with underlying liver
cirrhosis.
-- Establishment of safety in HCC patients was a key
pre-requisite to move forward with the further clinical development
of Milciclib. The treatment regimen with Milciclib (100mg/day; 4
days On/3 days Off, every 4 weeks) was safe and well-tolerated with
no drug-related SAEs in patients with unresectable or metastatic
HCC.
-- As a next step, a Phase 2b trial to evaluate safety and
clinical activity of Milciclib in combination with sorafenib
(NexavarÒ; Bayer Germany) in HCC is expected to start in Q2,
2018.
Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented:
"unresectable or metastatic HCC is an aggressive type of liver
cancer for which no satisfactory treatment is currently available.
The establishment of Milciclib's safety is a significant milestone
as it paves way to move forward with clinical studies evaluating
Milciclib in combination with sorafenib (NexavarÒ; Bayer) or
nivolumab (OpdivoÒ; Bristol Myers Squibb) for treatment of
HCC."
Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences,
commented: "Safety findings of Milciclib in HCC are consistent with
the findings reported earlier on the long-term safety and clinical
activity of Milciclib in thymic carcinoma, thymoma(1) and other
solid cancers(2) . Results from these clinical studies will
facilitate the further clinical development of Milciclib for
treatments of HCC and other cancers".
Cited References
1. Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. Cancer Chemother Pharmacol (2017). Phase I dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265.
2. Press Release on announcement of clinical data in thymoma and thymic carcinoma.
www.tizianalifesciences.com
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 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 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.
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
Beaufort Securities Limited (Broker)
Saif Janjua +44 (0)20 7382 8300
FTI Consulting
Simon Conway / Natalie Garland-Collins +44 (0)20 3727 1000
This information is provided by RNS
The company news service from the London Stock Exchange
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