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FDA approves clinical trial for potential HCC chemotherapy drug

The FDA approved the initiation of an investigational device exemption clinical trial of a potential chemotherapy drug, Oncozene, for the treatment of hepatocellular carcinoma, according to a news release from CeloNova BioSciences.

“Our oncozene microspheres platform, when combined with its precise drug delivery capability, presents a potentially improved treatment option for liver cancer patients,” Jane Ren, PhD, chief technology officer at CeloNova, said in the release.  “We are very pleased to be working with the leading [hepatocellular carcinoma] experts in the world to alleviate the pain of our patients.”

Oncozene (CeloNova) is comprised of small embolic microspheres with doxorubicin that combines selective embolization and distal penetration to increase the impact of chemotherapy on a specific tumor. The increased amount of chemotherapy works to lower the toxicity in other parts of the body and could improve a patient’s overall tolerance for treatment, according to the release.

“This [investigational device exemption] trial is designed to develop an evidence-based treatment plan for late stage HCC patients and will enroll patients in multiple cancer centers across the United States, Europe and Asia,” Riccardo Lencioni, MD, FSIR, EBIR, professor at the Pisa University School of Medicine, Italy and chairman of the World Conference on Interventional Oncology, said in the release.

Tandem, another microspheres platform, was approved by the European Union in 2012 for the embolization of HCC, according to the release.