UK-based biotechnology firm Tiziana Life Sciences has started patient enrolment in a Phase IIa clinical trial of milciclib for the treatment of hepatocellular carcinoma (HCC) patients.

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Milciclib is a small molecule inhibitor of various cyclin-dependent kinases (CDKs), including CDK1, CDK4, CDK5 and CDK7.

The multi-centre, multi-country Phase IIa trial will be conducted in Italy, Israel, Greece and Turkey to assess milciclib’s safety in refractory HCC patients who are not responding to or intolerant towards standard-of-care treatment sorafenib (Nexavar).

Top-line results from the dose-ranging trial are expected to be available in the fourth quarter of next year.

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Tiziana Life Sciences CEO and chief scientific officer Kunwar Shailubhai said: “Oral treatment with milciclib has been well-tolerated in previous studies with cancer patients.

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"We strongly believe, based on its unique mechanism of action, that the drug may have potential to be developed either as a monotherapy or combo-therapy with sorafenib for the treatment of HCC."

“We strongly believe, based on its unique mechanism of action, that the drug may have potential to be developed either as a monotherapy or combo-therapy with sorafenib for the treatment of HCC.”

According to prior Phase I clinical trial findings, oral milciclib was safe and well-tolerated for the treatment of solid tumours such as thymoma and thymic carcinoma, pancreatic carcinoma and colon cancer.

A dose-escalation Phase I trial further showed that combination of milciclib and a nucleoside analogue called gemcitabine had positive clinical responses in advanced or metastatic tumour patients, as well as in individuals who were previously resistant to gemcitabine.

Tiziana also intends to commence a Phase IIb clinical trial for HCC with milciclib and sorafenib combination.

Image: Hepatocellular carcinoma. Photo: courtesy of Ed Uthman.