- Tiziana Life Sciences has announced 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 had been submitted for approval in Italy, Turkey and Greece.

The primary objective of these multi-centred, multi-country and dose-ranging phase IIa clinical studies was 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 enrolment was expected next month and top line data from the trial was 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.

At 9:12am: [LON:TILS] Tiziana Life Sciences Plc Ord 3p share price was -4.5p at 214.5p

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