SillaJen신라젠, a Korean developer of bio drug, said Monday the first European patient been enrolled in its multinational Phase 3 trial for Pexa-Vec in advanced liver cancer, also known as hepatocellular carcinoma (HCC).
According to the contract with Transgene, a French pharmaceutical company, SillaJen will receive a $4-million milestone from Transgene. The patient was enrolled at Azienda Ospedaliero-Universitaria Hospital in Parma, Italy.
The study, named the PHOCUS trial, will evaluate the use of Pexa-Vec to treat HCC patients who have failed locoregional therapies and are eligible for treatment with sorafenib, the only approved systemic treatment for advanced HCC.
SillaJen and the U.S. Food and Drug Administration reached an agreement on an advanced declaration for the Phase 3 clinical trial.
“We are pleased with the progress in our PHOCUS trial and are happy to report that we are now enrolling patients in 11 countries across the globe,” stated Moon Eun-sang, chief executive officer of SillaJen. “This trial, which is actively enrolling patients with HCC, is being conducted at some of the most highly regarded institutions for cancer in the world, and we are grateful to be working with such an exemplary team of physicians.”
The primary objective of the study is to determine the overall survival of patients treated with Pexa-Vec. Secondary objectives include safety as well as assessments for tumor responses between the two groups as measured by time to progression, progression-free survival, overall response rate and disease control rate.
“The enrollment of the first patient in Europe in the PHOCUS trial is a significant step forward in the development of Pexa-Vec in association with the current standard of care in advanced liver cancer,” said Philippe Archinard, chairman and chief executive officer of Transgene. “This trial is part of a broad clinical development plan that will allow us to position this promising oncolytic virus in all relevant settings to improve the clinical outcome of patients with advanced solid tumors such as HCC, in which there still is a very high unmet medical need.”
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