Tiziana Life Sciences PLC Announces Publication of Milciclib Clinical Trial (9222C)
April 21 2017 - 2:00AM
UK Regulatory
TIDMTILS
RNS Number : 9222C
Tiziana Life Sciences PLC
21 April 2017
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana Life Sciences Announces Publication of Peer-Reviewed
Paper from Positive Clinical Trial of Milciclib in Patients with
Refractory Solid Tumours
Encouraging data from phase I study published in Cancer
Chemotherapy and Pharmacology
London, 21 April, 2017 - Tiziana Life Sciences plc (AIM: TILS,
the "Company"), a clinical stage biotechnology company developing
targeted drugs for cancer and autoimmune diseases, is pleased to
announce that a research article detailing the use of the Company's
lead compound, milciclib, has been published in the prestigious,
peer-reviewed journal Cancer Chemotherapy and Pharmacology,
entitled: "Phase I Dose-Escalation Study of Milciclib, A Novel
Inhibitor of Cyclin Dependent Kinases (CDKs), in Combination with
Gemcitabine in Patients with Refractory Solid Tumors"(1) .
In this phase I clinical trial, 16 patients with advanced
metastatic tumours, refractory to existing cancer therapies, were
enrolled. The treatment regimen consisted of oral treatment with
milciclib once daily for 7 days on/7 days off in a 4-week cycle
with concomitant gemcitabine administered intravenously once weekly
for 4 weeks. This combination treatment regimen showed positive
clinical responses in approximately 36% of patients, including
gemcitabine refractory patients. One patient with non-small cell
lung carcinoma (NSCLC), showed partial response and four patients
(one each with thyroid, prostatic, pancreatic carcinoma and
peritoneal mesothelioma) showed long-term disease stabilisation for
up to 14 months. In previous clinical studies, oral treatment with
milciclib, was found be safe and well tolerated in patients with
thymoma and thymic cancers.
Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented:
"Following the generation of encouraging phase I clinical data with
milciclib, reported in this important publication, we are rapidly
moving forward with further evaluation of the drug as an oral
treatment in phase IIa clinical trials for patients with refractory
hepatocellular carcinoma (HCC), which is a significant unmet
medical need. It is noteworthy that the combination treatment
regimen used in the phase I study also exhibited positive clinical
activity in patients who were previously resistant to treatment
with gemcitabine, a drug widely used as a partner in combination
therapies for treatment of refractory cancers. This suggests that
milciclib may have therapeutic potential in combination with other
existing therapies."
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.
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 Gemcitabine
Gemcitabine, a well-known nucleoside analogue sold under the
brand name GemzarÒ, is a widely used chemotherapeutic drug used
either as a monotherapy or in combination with other anti-cancer
agents
for treatment of a wide range of solid tumours. Synergism
between CDK inhibitors and gemcitabine has been shown in animal
studies as well as in a phase I trial with cancer patients.
About Cancer Chemotherapy and Pharmacology
Cancer Chemotherapy and Pharmacology is a journal addressing a
wide range of pharmacologic and oncologic concerns on both
experimental and clinical levels. Primary focus in this rapid
publication medium is on new anticancer agents, their experimental
screening, preclinical toxicology and pharmacology, single and
combined drug administration modalities, and clinical phase I, II
and III trials. It is essential reading for pharmacologists and
oncologists. The journal is published by Springer, which is part of
Springer Nature, a global publisher that serves and supports the
research community.
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.
Contacts
Tiziana Life Sciences plc +44 (0)20 7493
Gabriele Cerrone, Chairman and founder 2853
Cairn Financial Advisers LLP (Nominated
adviser) +44 (0)20 7213
Liam Murray / Jo Turner 0880
Beaufort Securities Limited (Broker) +44 (0)20 7382
Saif Janjua 8300
FTI Consulting +44 (0)20 3727
Simon Conway / Natalie Garland-Collins 1000
(1) Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. Cancer
Chemother Pharmacol (2017). doi:10.1007/s00280-017-3303-z
This information is provided by RNS
The company news service from the London Stock Exchange
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