Positive Preliminary Safety Findings in Phase 2 Hepatocellular Carcinoma Trial

According to a story from BioPortfolio, the biotechnology company Tiziana Life Sciences plc has announced the release of preliminary topline data findings from its phase 2a clinical trial, which tested the company’s drug milciclib as a treatment for patients with advanced hepatocellular carcinoma (liver cancer). The primary goal of this trial was evaluating the safety of this drug in this patient group. Tiziana is focused on the development of drugs to treat cancer and inflammatory diseases.

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.

Milciclib and Hepatocellular Carcinoma

While the primary endpoint of this trial was evaluating safety, efficacy data was also monitored, such as time to progression and progression free survival. The trial was around six months in duration and included a total of 31 patients. A total of 14 patients survived to complete the trial. Treatment with milciclib was generally well tolerated; adverse events included diarrhea, ascites, ataxia, fever, rash, and fatigue. These adverse events were considered manageable.

Nine of the patients continued treatment after the end of the study on compassionate use grounds with five of the patients currently using the drug. The latest surviving patient using the drug is on their 11th month of use.

These findings encourage the continued testing of this drug as a treatment for hepatocellular carcinoma, an extremely dangerous and aggressive cancer that has limited treatment options.


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