Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), a clinical-stage cancer biotherapeutics company, today announced that it has completed patient enrollment in a Phase 1 clinical trial evaluating the intravenous (IV) administration of JX-594, the company's lead product for the treatment of solid tumors. Jennerex expects to report the results from this trial at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in May 2010.
"Enrollment on this trial is now complete. We plan to report results from this trial in the near future showing that JX-594 can be safely and effectively delivered to metastasized tumors through intravenous administration," said David H. Kirn, M.D., president and chief executive officer of Jennerex. "We intend to use the optimized IV dose in our planned Phase 3 study that will evaluate the efficacy of both intratumoral and IV administration of JX-594 for the treatment of liver cancer scheduled to begin in the second half of 2010. In addition, we will use this IV dose in a Phase 2 trial in colorectal cancer."
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. The primary endpoints of the trial included safety and determination of the maximum tolerated dose given through intravenous administration. A biomarker analysis predictive of viral replication in distant tumors is also being conducted.