TILS.L Regulatory News (TILS)

Tiziana Life Sciences PLC

("Tiziana" or "the Company")

Tiziana Life Sciences strengthens unique research focus by appointing

Dr Kunwar Shailubhai as Chief Executive Officer

London, UK - 12 June, 2017 - Tiziana Life Sciences (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and autoimmune diseases, is pleased to announce the appointment of Dr Kunwar Shailubhai (Shailu) as Chief Executive Officer and Chief Scientific Officer with immediate effect. Shailu was previously a Non-Executive Director at the Company.

He takes the reins of the company at a significant time for Tiziana Life Sciences, which is the only company in the world developing an orally administered fully human anti-CD3 mAb (foralumab) as a drug candidate to manage NASH, a liver disease that affects millions of people worldwide, for which there is currently no treatment. The timing of his appointment is noteworthy as Tiziana prepares to proceed with Phase II of its trials to develop foralumab as a treatment for NASH.

Crucial experience delivering FDA approved drug development

Shailu has extensive experience within the sector, drawing on 30 years of experience in research and development of drug candidates for treatment of gastrointestinal disorders, inflammatory diseases and cancers. His appointment follows many years working at Synergy Pharmaceuticals Inc (SGYP: NASDAQ), which he co-founded and where he served as chief scientific officer since 2008.

His pioneering research programme culminated in the development of the drug Trulance™ (plecanatide) which received FDA approval in January, 2017 for the treatment of adults with chronic idiopathic constipation. A supplemental new drug application has been submitted for FDA review of Trulance for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Prior to joining Tiziana Life Sciences and Synergy Life Sciences, he worked at Callisto Pharmaceuticals, Monsanto Company and as a senior staff fellow at the National Institutes of Health (NIH).

Founded in 2013 and based in London, Tiziana Life Sciences is focused on oncology, inflammatory and immunology diseases. Set up by experienced biotechnology entrepreneur Gabriele Cerrone, the company combines field-leading medical scientists with clinical development experts to apply commercial realism to challenging, high-potential opportunities.

The company is also conducting phase II clinical trials with milciclib, a small molecule inhibitor of cyclin dependent kinases (CDK) for hepatocellular carcinoma (HCC). A recently published article in the journal Cancer Chemotherapy and Pharmacology concluded that a treatment regimen consisting of a combination of milciclib (oral) with gemcitabine (intravenous) was safe and well tolerated and that the treatment showed encouraging clinical benefits to patients with refractory solid cancers. These results warranted development of milciclib for treatment of other cancers, such as liver carcinoma and breast cancer. The company is currently conducting phase II clinical studies across four countries with milciclib in HCC patients who are intolerant to treatment with Sorafenib®.

Bringing onboard world class expertise

Tiziana Life Sciences has recently been growing its core Scientific Advisory Board, bringing on board some of the world's leading scientists researching oral treatment with anti-CD3 (Foralumab) and liver diseases. Dr Howard Weiner, Professor of Neurology at Harvard Medical School and Dr Kevan Herold, Professor of Immunobiology at the Yale School of Medicine and Director of the Yale Diabetes Center, both have been serving pivotal roles driving Tiziana's R&D pipeline. Earlier this year, Dr Arun Sanyal, Professor of Medicine, Physiology and Molecular Pathology, at the Virginia Commonwealth University (VCU) and former President of the American Association for the Study of Liver Diseases (AASLD) was appointed the Advisory Board, bringing extensive experience within the area of research.

Gabriele Cerrone, Executive Chairman at Tiziana Life Sciences, said: "Having Shailu as our CEO demonstrates our commitment to put our research first and his expertise at some of the top pharmaceutical companies globally means Tiziana Life Sciences can go from strength to strength. In particular, his experience shows he knows what it takes to shepherd research from inception to FDA approval and I know his passion for this area of work will pay off."

Dr Kunwar Shailubhai, Chief Executive Officer, said: "This is a crucial time to be taking on this new role with Tiziana Life Sciences in what is one of the most vital yet underdeveloped research areas. NASH affects more than three million people in the UK alone and there is no cure, and now we have the team and the approach necessary to make important steps to manage this disease."

Tiziana Life Sciences is developing foralumab for treatments of autoimmune and inflammatory diseases. Currently, the company is conducting clinical studies with this asset to manage non-alcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease (NAFLD), a condition in which fat builds up in the liver. NASH causes inflammation and liver cell damage, resulting in the scarring of the liver and left untreated it can lead to cirrhosis or liver cancer. Currently there is no approved treatment for NASH, despite up to 12 per cent of adults in the United States estimated to have NASH1, while in the UK the NHS estimates more than 3 million people are living with it2. Tiziana's clinical trial is based on the research of Dr Harold Weiner and is set to be the first orally-administered anti-CD3 antibody of its kind, representing enormous potential for treatment of liver and autoimmune diseases.

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. Although the prevalence of HCC is relatively lower in the Western hemisphere than in Eastern Asia, there is an increase of HCC in the Western countries. The diagnosis of HCC has increased since the 1980s and it is continuing to increase, making it one of the rising causes of death due to cancer. The most common risk factors for HCC are chronic infections with hepatitis viruses (HCV and HBV) along with other health issues. Males are affected more than females usually and it is most common between the age of 30 to 50. HCC causes approximately 660,000 deaths worldwide every year.

1 The National Institute of Diabetes and Digestive and Kidney Diseases

2 http://www.nhs.uk/conditions/fatty-liver-disease/Pages/Introduction.aspx 

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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