Tiziana Life Sciences PLC ("Tiziana" or the "Company") Tiziana Reports Encouraging Interim Clinical Data from an Ongoing Phase 2a Trial with milciclib in Advanced Liver Cancer Patients - 80% of patients who completed tre

Tiziana Life Sciences PLC

Encouraging Interim Clinical Data from an Ongoing Phase 2a Trial with milciclib in Advanced Liver Cancer Patients

York/London, 24 April 2019 - 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, today announced

results from the interim safety review conducted by the Independent Data Monitoring Committee (IDMC) on March 21, 2019. The

IDMC reviewed safety data from patients as of February 26, 2019, and concluded that the administration of milciclib to

patients with advanced hepatocellular carcinoma (HCC) was not associated with unexpected signs or signals of toxicity.

Additionally, a number of patients are continuing with treatment under compassionate use. Topline data from this multi-center

trial is expected to be available by the end of Q3 2019.

Phase 2a clinical trial is a single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off every 4 weeks defining each cycle),

6-month duration study to evaluate the safety, tolerability and anti-tumor activity of milciclib in Sorafenib-refractory or intolerant

patients with unresectable or metastatic advanced HCC, the most common form of liver cancer. Enrollment of 31 patients in Italy,

Greece, and Israel was completed on November 30, 2018.

data from 28 out of the 31 patients who were evaluable. As of April 16, 2019, a total of 10 out of 27 patients have completed the

study per protocol (6 cycles, 6 months). Four patients are still under treatment, while 3 are in cycle 6 and 1 is in cycle 5. Eight

out of the 10 patients who completed treatment initially expressed interest to continue with treatment. Seven of these 8 patients

were approved to continue with treatment under compassionate use by their respective Ethical Committees.Three of the patients under

compassionate use have completed 9, 13, and 16 months of treatment with milciclib. The other 4 patients are continuing with treatment.

So far, no drug-related

deaths have been recorded. Overall, the treatment with milciclib is well-tolerated with manageable drug-related toxicities. These

safety and clinical activity are consistent with the earlier reported long-term safety and clinical activity of milciclib in thymic

carcinoma, thymoma1 and other solid cancers2.

of safety and clinical activity is important milestone to move forward with strategic options for further clinical development

of milciclib either as a single agent or in combination with one of the FDA approved drugs for treatment of HCC patients,"

said Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. We previously reported data from preclinical studies demonstrating

that milciclib produced pronounced synergistic anti-HCC activity in combination with any one of the FDA approved drugs such as

sorafenib (Nexavar ), regorafenib (Stivarga ), and lenvatinib (Lenvima )3."

contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

For further enquiries:

1. Besse, B,, Garassino, M,, Rajan,

A., Novello, S.,Mazieres, J., Weiss, G., Kocs, D., Barnett, J, Davite, C, Crivori, P and G. Giaccone. Efficacy of <ilcicilib

(PHA-848125AC), a pan-cyclin D -dependent kinase inhibitor in tow phase II studies with Thymic carcinoma and B3 thymoma patients.

(2018) J. Clin. Onc 36 (15 suppl): 8519

2. Aspeslagh, S., Shailubhai, K.,

Bahleda, R. et al. (2017). Phase I dose-escalation study of milciclib in combination with gemcitabine in patients with refractory

solid tumors. Cancer Chemother Pharmacol. 79:1257-1265.

3. Jindal, A., Palejwala, V. and

Shailubhai, K. (2018). Oral treatment with milciclib either alone or in combination with sorafenib inhibited tumor growth in an

orthotopic model of hepatocellular carcinoma. Hepatology 68 Number 1 (Suppl): 879A (Abstract 1543)

most common cancer and the third highest cause of cancer mortality worldwide. In 2007, the approval by the European Medical

Agency (EMA) and U.S. 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, with a response rate less than 3%, an improvement in median survival of 2-3 months and drug-related symptoms

that are not ordinary. More recently, lenvatinib (Lenvima ), another multi-tyrosine kinase inhibitor was also approved for

first line treatment of HCC. 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).

milciclib (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.

About Tiziana Life Sciences

Tiziana 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.