UK-based biotechnology firm Tiziana Life Sciences has received approval for the initiation of its Phase II clinical trial of milciclib in Israel to treat refractory hepatocellular carcinoma (HCC).

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Milciclib is a small molecule, cell cycle-dependent kinases (CDKs) inhibitor.

Designed to assess the safety of milciclib, the multi-centred, multi-country and dose-ranging Phase II trial is expected to begin patient enrolment next month.

The trial will recruit patients who fail to respond or are intolerant to the standard of care treatment.

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Tiziana chairman Gabriele Cerrone said: "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.

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"We strongly believe that milciclib has the potential to be developed either as a monotherapy or in combination with sorafenib for treatment of HCC.”

According to results from prior clinical trials, the orally administered milciclib was safe and well-tolerated in refractory solid tumours, thymoma and thymic cancer patients.

"We strongly believe that milciclib has the potential to be developed either as a monotherapy or in combination with sorafenib for treatment of HCC."

The previous preclinical studies conducted in mice indicated that milciclib may downregulate microRNA (miR) 221 and 222 to suppress tumour growth.

The miR 221 and 222 are reported to be associated with hepatocarcinogenesis and development of resistance to sorafenib (Nexavar) in patients with HCC.

The trial's top-line results are expected to be available by the third quarter of next year.

Tiziana has submitted a similar clinical trial protocol for approval in Italy, Turkey and Greece.

Image: Illustration of hepatocellular carcinoma. Photo: courtesy of Ed Uthman/flickr.