FDA Approves Celsion's Study Of ThermoDox For Liver Cancer
By Cyndi Root
Celsion Corporation announced in a press release that the Food and Drug Administration (FDA) has approved a Phase III trial for ThermoDox. The study was designed by Celsion, the FDA, clinical advisors, and statisticians and is expected to begin shortly. ThermoDox is indicated for liver cancer. Nicholas Borys, MD, Celsion's Chief Medical Officer said, "ThermoDox appears to hold great promise as a first-line treatment when used in combination with optimized RFA, for primary liver cancer, one of the most deadly and prevalent forms of cancer worldwide.”
Liver cancer is also known as hepatocellular carcinoma (HCC) because most types of liver cancer are HCC. The disease is most prevalent in men and people older than 50 years of age. The disease results most often from cirrhosis, scarring of the liver. Causes include autoimmune diseases, alcoholism, and virus infection. People experience yellow eyes and skin, easy bleeding or bruising, enlarged stomach, and pain in the abdominal area.
ThermoDox is a liposomal encapsulation of doxorubicin that is combined with radio frequency ablation (RFA). When designing the new trial, the company relied on results from its Phase III HEAT Study, which showed improvement in survival for those patients treated with ThermoDox. The HEAT Study showed that the subgroup of patients whose RFA treatment of 45 or more minutes experienced a 55 percent overall improvement in survival. Celsion is working with patients on a quarterly basis to gauge longer survival effects. Celsion has presented its finding on the HEAT study at three medical conferences.
The OPTIMA Study is a Phase III trial. Celsion brought together experts in HCC to design the trial and consulted with the FDA before finalizing the trial. The company intends to enroll over 500 people in the U.S. and selected sites in Europe and Asia. All participants will receive at least 45 minutes of therapy. Overall survival (OS) is the primary endpoint of the study. During the study, an independent Data Monitoring Committee (iDMC) will conduct two interim efficacy analyses.
About Celsion Corporation
Celsion develops cancer drugs including heat-activated liposomal drug technology. The company partners with U.S. and international institutions and companies like the National Institutes of Health, the UCLA Department of Medicine, and the University of Oxford. Celsion has met with China’s FDA office and intends to meet with European authorities regarding the OPTIMA trial and future efforts to register and approve ThermoDox.