Tiziana Life Sciences Announces Publication of Peer-Reviewed Paper from Positive Clinical Trial of Milciclib in Patients with...
21 April 2017 - 5:34PM
Business Wire
Encouraging data from phase I study published in Cancer
Chemotherapy and Pharmacology
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 G1 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 Gemzar®, 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.
1 Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. Cancer
Chemother Pharmacol (2017). doi:10.1007/s00280-017-3303-z
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version on businesswire.com: http://www.businesswire.com/news/home/20170421005176/en/
Tiziana Life Sciences plcGabriele Cerrone, Chairman and
founder+44 (0)20 7493 2853orCairn Financial Advisers LLP
(Nominated adviser)Liam Murray / Jo Turner+44 (0)20 7213
0880orBeaufort Securities Limited (Broker)Saif Janjua+44
(0)20 7382 8300orFTI ConsultingSimon Conway / Natalie
Garland-Collins+44 (0)20 3727 1000
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