Pharma Focus Asia

Tiziana Life Sciences Announces Approval of a Phase II Clinical Trial Protocol for Milciclib

Monday, April 24, 2017

Tiziana Life Sciences plc, 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."

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