Jennerex initiates JX-594 Phase 2 trial in advanced hepatocellular carcinoma

Jennerex, Inc., a private, clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic immunotherapies, today announced that the first patient has been treated in a Phase 2 clinical trial of intravenous treatment with JX-594 for patients with advanced hepatocellular carcinoma (HCC), or liver cancer, who have not received treatment with sorafenib—the current standard of care for this patient population.  This trial expands the development of the JX-594 program in HCC, which is currently being evaluated in a multi-national Phase 2b trial (TRAVERSE) in patients with advanced HCC who have failed prior sorafenib.

This Phase 2 trial is a multinational, single-arm, open-label study of JX-594 administered weekly by intravenous infusions in sorafenib-naive patients with advanced HCC. The primary objective of the study is to determine the radiographic response rate based on modified RECIST and modified Choi criteria.  Patients will subsequently be followed for progression-free survival and overall survival. The trial is being conducted at sites in South Korea, the United States, and Europe.  For more information about this trial as well as the Phase 2b TRAVERSE trial, please visit www.clinicaltrials.gov.

"We are pleased to have treated our first patient in this study, which will build on our experience with intravenous treatment with JX-594 and will allow us to assess anti-tumor activity of multiple intravenous infusions in the liver cancer patients specifically," said David H. Kirn, M.D., founder, chief medical officer and president of research and development.  "Unlike other treatments in the class, JX-594 can be administered intravenously, and we've shown that it has the ability to target tumors systemically—in addition to locally—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."