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Tiziana Life Sciences plc (" Tiziana " or the " Company ") Tiziana Life Sciences Announces Online Publication of Two Abstracts at the American Society of Clinical Oncology (ASCO) Reporting Clinical Activity and Safety of

Key Takeaway: Sciences Announces Online Publication of Two Abstracts at the American Society of Clinical Oncology (ASCO) Reporting Clinical Activity and Safety of Milciclib in Patients with Advanced Hepatocellular Carcinoma This announcement contains inside information for the purposes of A

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Sciences Announces Online Publication of Two Abstracts at the American Society of Clinical Oncology (ASCO) Reporting Clinical
Activity and Safety of Milciclib in Patients with Advanced Hepatocellular Carcinoma
This announcement contains
inside information for the purposes of Article 7 of EU Regulation 596/2014.
York and London, May 14, 2020 - Tiziana Life Sciences plc (NASDAQ: TLSA, AIM: TILS) ("Tiziana" or the "Company"),
a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces
the online publication of two abstracts on clinical studies with Milciclib, a small molecule pan-inhibitor of cyclin dependent
kinases (CDKs) in the proceedings of the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20).
abstract reports Phase 2a clinical data with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma (HCC)
patients, for which it met the primary endpoint that oral treatment with Milciclib was well tolerated with manageable toxicities
and no recorded drug-related deaths. The second abstract reports clinical data from an ongoing investigator-originated trial with
combination of orally administered Milciclib and Regorafenib in liver transplant patients with recurrent HCC. Thus far, the study
has shown mean AFP levels (a common tumor biomarker) reduced by a mean of approximately 20% within one month of treatment.
Abstract #298561: Phase
2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant
Hepatocellular Carcinoma Patients. First Author: Erica Villa, MD., et al.
cases of patients with HCC have limited therapeutic options because of the poor safety and tolerability of existing drugs. Thus,
a newer drug, preferentially with a different mechanism of action, such as Milciclib is a necessary medical need," stated
Prof. Angelo Sangiovanni, M.D. principal investigator of the study and site investigator at Fondazione
IRCCS C Granda Ospedale Maggiore Policlinico, Milan, Italy. "In this context,
safety, and tolerability of oral treatment with Milciclib is remarkable. Results from the phase 2a clinical study demonstrating
clinical activity in these advance cases of HCC are notable. The fact that many of the treated patients continued with the treatment,
even after completing 6 months duration of the study, is particularly very impressive."
#307309: Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients
with Hepatocellular Carcinoma Recurrence. First Author: Alessandro Pivetti. MD., et al.
center has been involved with clinical evaluation of several drug candidates in advanced HCC patients and both of the above-mentioned
studies were conducted at our site. The oral treatment with Milciclib is not only very well tolerated but it also showed clinical
activity. Most of these patients with advance cases of HCC are exhibiting stabilization of disease and have continued the treatment
under compassionate use program, which in my opinion is very impressive," added Prof. Erica
Villa, M.D., site Investigator at the Policlinico di Modena, Modena, Italy. "Moreover,
the positive clinical activity and impressive safety and tolerability of Milciclib in combination with Regorafenib in liver transplant
patients with recurrent HCC is certainly noteworthy. Thus, clinical data from these two studies are very encouraging and warrant
continued development of Milciclib, either as monotherapy or combination therapy."
Milciclib (TZLS-201)
(PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, 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. 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 NSCLC, pancreatic and colon
cancer, thymic carcinoma and thymoma.
Tiziana Life Sciences
Tiziana Life Sciences
plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development
of novel molecules to treat human diseases in oncology inflammation and infectious diseases. In addition to milciclib, the Company
will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered
Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical
development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases,
such as Crohn's Disease multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid
arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor
(IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19
Society of Clinical Oncology (ASCO) was established in 1964 with the sole purpose of improving the care of people with cancer.
Membership currently stands at 40,000 physicians and scientists. ASCO is one of the premiere organizations for the advancement
of cancer treatments and the annual ASCO meeting is an important forum for discussion of new cancer therapies and treatments.
For more information go to http://www.tizianalifesciences.com
THE PERSON WHO ARRANGED
FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY'S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC OFFICER.
Contacts : Tiziana Life Sciences plc United Kingdom:
Tiziana Life Sciences plc Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser) Liam Murray / Jo Turner +44 (0)20 7213 0883
Shore Capital (Broker) Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125
United States:
Investors-
CORE IR
(516) 222-2560
ir@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Last updated: May 14, 2020