CeloNova BioSciences has announced that the US FDA has granted approval to start an investigational device exemption (IDE) clinical trial for its Oncozene embolic microspheres, loaded with doxorubicin, a chemotherapy drug used in the treatment of hepatocellular carcinoma.
The small sizes and precise calibration of Oncozene allow for superselective embolization combined with distal penetration which may greatly increase the chemotherapeutic impact at the tumour site, while lowering the toxicity in other parts of the body, and thereby potentially improving the patient’s tolerance of the treatment, a company press release said. CeloNova’s Tandem microspheres are available in Europe and bear the CE mark since it was granted in 2012 for embolization of hepatocellular carcinoma, with or without delivery of doxorubicin.
“We are excited to move Oncozene microspheres into a pivotal phase 3 trial,” said Ghassan Abou-Alfa, Memorial Sloan-Kettering Cancer Center, New York, USA. “Early studies have shown that liver-directed therapies utilising drug-eluting microspheres such as Oncozene microspheres provide an excellent treatment option for locally advanced hepatocellular carcinoma patients.
“This IDE trial is designed to develop an evidence-based treatment plan for late stage hepatocellular carcinoma patients and will enroll patients in multiple cancer centres across the USA, Europe and Asia,” said Riccardo Lencioni, Pisa University School of Medicine, Italy, and chairman of the World Conference on Interventional Oncology (WCIO).
The company announced on 3 September 2014 that the FDA had issued 510(k) clearance expanding the indication of its Oncozene and Embozene microspheres products to include the treatment of hepatoma, also known as hepatocellular carcinoma.