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Tiziana Life Sciences Announces Publication of Peer-Reviewed Paper from Positive Clinical Trial of Milciclib in Patients with Refractory Solid Tumours


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

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

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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