Tiziana Life Sciences plc ("Tiziana" or the "Company") Tiziana Completes Patient Enrollment in a Phase 2a Trial to Evaluate Tolerability and Anti-Tumor Activity of Milciclib in Hepatocellular Carcinoma (HCC) New York/Lon

Tiziana Life Sciences plc

("Tiziana" or the "Company")

Completes Patient Enrollment in a Phase 2a Trial to Evaluate Tolerability and Anti-Tumor Activity of Milciclib in Hepatocellular

York/London, 3 December 2018 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a biotechnology company focusing

on the discovery and development of innovative therapeutics for inflammation and oncology indications, announces that patient

enrollment in the ongoing Phase 2a clinical trial (CDKO-125A-010) is completed. This is a single-arm, repeated-dose, 6-month duration

study to evaluate safety, tolerability and anti-tumor activity of Milciclib in Sorafenib-refractory or -intolerant patients with

unresectable or metastatic HCC. Topline data from this multi-center trial, being conducted in Italy, Greece and Israel, will be

available in the second quarter of 2019.

we reported interim analysis data from the first 10 patients, following 6 months of treatment, showing that Milciclib (100 mg

once daily; 4 days on/3 days off every 4 weeks defining each cycle) was well-tolerated in this HCC patient population. It was

concluded by an Independent Data Monitoring Committee (IDMC) that there were no major signals of tolerability concerns, and the

IDMC allowed continuation of patient enrollment in the trial. Following completion of 6 months of treatment, three patients opted

to continue treatment under the compassionate use program. Notably, one patient is still continuing treatment in the 14th

month and the other two patients received treatment until 9th month and 13th month, respectively.

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 (Nexavar ), an inhibitor of several

receptor tyrosine kinases, 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. The complex multi-factorial etiology of HCC warrants a need for systemic therapies

that target different signaling cascades to provide improved efficacy and safety for both naive patients presenting with unresectable,

advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

(PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases 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 signaling pathways that regulate cell cycles have been frequently associated with development of resistance towards

chemotherapies. In a Phase 1 study, oral treatment with Milciclib was well-tolerated and the drug showed promising clinical

responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.

Additionally, milciclib met its primary endpoint in two separate Phase 2 multi-center clinical trials (CDKO-125A-006: 72 patients

and CDKO-125A-007: 30 patients) in thymic carcinoma and thymoma patients.

(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), 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.

Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to

treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases.

Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. 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.

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