Early Trial Data Suggests Safety and Potential Efficacy of Experimental Drug in Treating Advanced Hepatocellular Carcinoma

According to a story from BioPortfolio, the biotechnology company Tiziana Life Sciences plc recently announced encouraging results from an interim safety review of the company’s Phase 2a clinical trial. This trial is testing the experimental CDK inhibitor milciclib as a treatment in patients with advanced, metastatic hepatocellular carcinoma, or liver cancer. This type of cancer is well known for its lethality when it cannot be effectively removed by surgery.

About Hepatocellular Carcinoma

Hepatocellular carcinoma is a type of liver cancer. Although generally considered rare, at least in developed countries, it is the most common type of cancer to originate in the liver in adults and is also the most common cause of death for people who develop cirrhosis. Risk factors are generally any condition that can lead to long term liver damage and cirrhosis, such as certain genetic disorders, chronic hepatitis, type 2 diabetes, nonalcoholic steatohepatitis, and severe alcohol abuse. The cancer is associated with common symptoms of liver dysfunction and damage, such as jaundice, fatigue, abdominal swelling, nausea and vomiting, bruising easily, abdominal pain, loss of appetite, and weight loss. Treatment may include kinase inhibitors, surgery, liver transplant, arterial catheters, and ablation. Survival rates are poor; cancer that cannot be removed with surgery is usually lethal within a year. To learn more about hepatocellular carcinoma, click here.

Safety Results

The review concluded that treatment of patients with hepatocellular carcinoma using milciclib was not associated with unexpected toxicity. A number of patients in the trial have continued to receive treatment under compassionate use. The safety findings in this study are largely consistent with the results found in earlier studies of milciclib.

The Phase 2a clinical trial is a six month long study that included 31 patients with hepatocellular carcinoma. So far, ten patients have completed the study. Of this group, seven patients are continuing treatment with milciclib under compassionate use, suggesting a positive effect.

About Milciclib

Milciclib is an investigational inhibitor of CDK, or cyclin dependent kinases. The overexpression of CDKs is widely associated with resistance to chemotherapy treatment in a number of cancers. This experimental therapy is undergoing early stage testing in a number of cancer types, such as thymoma, colon cancer, pancreatic cancer, non small cell lung carcinoma, and thymic carcinoma.


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