SillaJen and Lee’s Pharmaceutical Holdings have said that they’ve gotten the approval from the China Food and Drug Administration (CFDA) to get a Phase 3 clinical trial for advanced liver cancer using its oncolytic immunotherapy called Pexa-Vec (formerly JX-594), the PHOCUS study.
SillaJen and Lee’s Pharmaceutical took part in a first of its kind Chinese Center for Drug Evaluation advisory committee meeting for this approval, which was held earlier this year to promote transparency in the China drug development process. At the end of the meeting, the committee voted, and it was announced by the chairman of the advisory committee, that the trial had been approved to be conducted in China.
The PHOCUS trial, is a global Phase 3 study, for patients who have not received prior systemic treatment for their cancer, and they will be randomized to one of two treatment groups: one which will receive Pexa-Vec followed by sorafenib and one which will receive sorafenib alone. The randomized study will be conducted in North America, Asia, Australia, and Europe, with China being the most recent addition. The primary objective of the study will be to determine the overall survival of patients treated with Pexa-Vec, followed by sorafenib versus sorafenib alone.
Dr. Eun Sang Moon, chief executive officer of SillaJen, said that this was an important milestone for the company’s Pexa-Vec program. “We are keenly aware of the high unmet needs in liver cancer in China, and it is our sincere hope that we will be able to offer Pexa-Vec to these patients in the years ahead,” Moon said.
Dr. Benjamin Li, chief executive officer of Lee’s Pharmaceutical, said: .“We are glad that the CDE of China CFDA has approved our phase III IND application, and we look forward to enrolling the PHOCUS trial in China. This is an important milestone for Pexa-Vec development, and is a result of our tremendous team work with SillaJen.”