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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“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.
