This open-label, dose-escalation study was completed at four sites in the United States 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.
JX-594, currently in Phase 2 clinical trials for liver cancer, is a cancer biotherapeutic product from a proprietary breakthrough class of targeted and armed oncolytic and immunotherapeutic poxviruses. Tumor destruction and safety was shown in patients with diverse cancer types in three Phase 1 trials; treated patients were end-stage and had no effective therapies available. JX-594 multiplies selectively within cancer cells, leading to their destruction. These newly created copies of JX-594 are then released and are able to infect and eradicate other tumor cells
|SOURCE Jennerex, Inc.|
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