Researchers at the University of Tennessee Medical Center have treated the first patient in the phase 3 clinical trial for the hepatocellular carcinoma medication Pexa-Vec, according to a press release.
“Having been involved in a prior clinical trial using Pexa-Vec, I remain excited about the potential this new cancer immunotherapy holds,” Laura Findeiss, MD, professor and chair of the department of radiology at the University of Tennessee Medical Center and UT Graduate School of Medicine, said in the release. “At the University of Tennessee Medical Center, we are at the forefront of bringing innovative cancer treatment to patients.”
Pexa-Vec, which is designed by SillaJen to be injected directly into the HCC tumor, is a vaccinia virus modified to destroy cancer cells and to create an immune response to the cancer, according to the release. This phase 3 study, known as the PHOCUS trial, will assess the effectiveness of Pexa-Vec combined with standard sorafenib (Nexavar, Bayer) in 600 patients at 140 sites worldwide. Researchers will select patients for the study if they have failed localized therapies and have not already undergone systemic treatment. Half of these patients will receive sorafenib, the only currently approved drug for HCC, while the other half will receive Pexa-Vec followed by sorafenib. The primary objective will be to determine the overall survival of patients in each group and the secondary objectives will be to determine the drug’s safety and overall tumor response.
“Primary liver cancer remains an unmet medical need for thousands of newly diagnosed patients and their families,” Eun Sang Moon, CEO of SillaJen, said. “We hope that the initiation of the global PHOCUS trial is an early step toward developing a new treatment for this disease.” – by Will Offit
Disclosure: Healio.com/Hepatology was unable to confirm Findeiss’ relevant financial disclosures at the time of publication. Moon is an employee of SillaJen.
Editor’s note: This article is based on a previously released news alert from March 2016.