Tiziana Life Sciences Plc Announces Approval Of A Phase II Clinical Trial Protocol For Milciclib In Patients With Hepatocellular Carcinoma

LONDON--(BUSINESS WIRE)--Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and autoimmune diseases, today announces the approval in Israel of a phase II clinical trial protocol for testing milciclib, a novel inhibitor of cell cycle dependent kinases (CDKs), in patients with refractory hepatocellular carcinoma (“HCC”). A similar clinical trial protocol has been submitted for approval in Italy, Turkey and Greece. The primary objective of these multi-centered, multi-country and dose-ranging phase IIa clinical studies is to evaluate the safety of milciclib in HCC patients who fail to respond or are intolerant to the existing standard of care treatment. First patient enrollment is expected next month and top line data from the trial is expected by Q3 2018.

In previous clinical studies, oral treatment with milciclib was found to be safe and well-tolerated in patients with refractory solid tumours, thymoma and thymic cancers. Data from animal studies has demonstrated that oral administration with milciclib effectively suppressed tumour growth in mouse models of HCC. Although the precise mode of action is not clearly understood, the preclinical studies conducted strongly suggest that milciclib acts primarily through downregulation of microRNA (miR) 221 and 222, which are known to be associated with hepatocarcinogenesis. Overexpression of miR-221 and miR-222 is also believed to be associated with development of resistance to sorafenib (Nexavar®) in HCC patients

Gabriele Cerrone, Chairman of Tiziana commented: “HCC is a real unmet medical need due to its growing incidence and lack of effective therapy. It is the fifth most common cancer worldwide and the second most common cause of death from cancer worldwide. We strongly believe that milciclib has the potential to be developed either as a monotherapy or in combination with sorafenib for treatment of HCC.”

Dr. Yaron Ilan, Director of the Department of Medicine at Hebrew University Hadassah Medical Center, Israel and Chief Medical Officer of Tiziana added: “The prognosis for liver cancer is very poor due to lack of effective therapy. We were very encouraged with recent pre-clinical findings and are now moving forward to conduct a phase II clinical trial in HCC patients with milciclib in patients that failed to respond to the standard of care therapy. We believe that milciclib holds promise as an effective anti-cancer treatment with a high safety profile.”

About HCC

Hepatocellular carcinoma is the fifth most common cancer in men and the ninth in women. Additionally, it is the fifth most common cancer worldwide and the second most common cause of death from cancer worldwide.¹ The tumour is associated with chronic hepatitis B and chronic hepatitis C infections, as well as with nonalcoholic steatohepatitis. The prognosis for liver cancer is very poor due to lack of effective therapy.

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 signaling 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 cancer.

About Yaron Ilan, MD

Prof. Yaron Ilan is the Director of the Department of Medicine at the Hadassah-Hebrew University Medical Center in Jerusalem Israel and served as the Vice Dean of the Hebrew University-Hadassah Medical School. He has pioneered the development of oral immunotherapy for HCC, NASH, diabetes, and inflammatory bowel diseases. He developed several products which target the immune system of the gastrointestinal tract as a mean for alleviating immune-mediated disorders without the need for immunosuppression. He holds over 50 patents for discoveries based on his research mainly in oral immunotherapy and mucosal immunology. His clinical interests are in the management of NASH and diabetes by targeting the inflammation-associated with these diseases by using products with high safety profile enabling their chronic use. He is involved in multiple clinical trials using oral immunotherapy-based compounds.

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

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

¹ http://www.who.int/mediacentre/factsheets/fs297/en/