The multinational, single-arm, open-label study of JX-594 is administered weekly by intravenous infusions in sorafenib-naive patients with advanced HCC. The trial will be conducted in South Korea, US and Europe.
The radiographic response rate based on modified RECIST and modified Choi criteria is the primary objective of the study and the patients will subsequently be followed for progression-free survival and overall survival.
Jennerex research and development president and chief medical officer David Kirn said unlike other treatments in the class, JX-594 can be administered intravenously, and it has the ability to target tumors systemically and, therefore, has the potential to impact both metastatic and primary tumors.
"In our previously reported randomized Phase 2 dose-ranging study in HCC with intratumoral delivery, we showed a statistically significant benefit in overall survival in the high dose group, which we believe was due, in large part, to the systemic delivery of JX-594 at that dose level," Kirn added.