According to Jennerex, the presented data demonstrated clear dose-related delivery to solid tumors, cancer-targeted replication and gene expression, and anti-cancer effects of JX-594 delivered IV. Choi (necrotic) responses were more commonly observed in patients treated at higher doses. In addition, intravenous infusion of JX-594 was safe and well-tolerated.
The open-label, dose-escalation study was completed at four sites in the US and Canada. A total of 23 patients with solid tumors refractory to standard therapy were enrolled. Patients received a single treatment at one of five dose levels, with follow-up at periodic intervals.
Six out of eight patients in the higher-dose cohorts evaluable to date (cohorts 3, 4, 5) exhibited disease control as defined by stable disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria and/or Choi (necrotic) response. Two out of six patients in the low dose cohorts exhibited disease control (RECIST stable disease) but no responses.
The primary endpoints of the trial included safety and determination of the maximum tolerated dose given through intravenous administration. No serious adverse events related to JX-594 therapy were reported and no dose-limiting toxicities were reported. A biomarker analysis further strengthened the finding of dose-dependent replication in tumors following IV administration.
David Kirn, president and CEO of Jennerex, said: “These data represent a significant milestone for the field of oncology and viral therapy as this is the first time that a viral or genetic product has demonstrated reproducible, biopsy-proven delivery to multiple solid tumor types following intravenous administration.
“We look forward to extending our experience with IV JX-594 in our planned Phase 3 trial in patients with advanced liver cancer. This pivotal trial will utilize both IV and targeted intratumoral injections of JX-594 to maximize potential patient benefit. We expect to initiate this study in Q4 of 2010.”