May 21 2010
Jennerex, Inc., a clinical-stage cancer biotherapeutics company, today reported positive results from its Phase 1 dose escalation study evaluating the intravenous (IV) administration of JX-594 to patients with metastatic cancer. The data presented today 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. These data were presented today at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in Washington DC.
"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," said David H. Kirn, M.D., president and chief executive officer of Jennerex. "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."
"JX-594 represents a promising potential treatment option for patients with multiple types of cancer. As the first intravenous biological immunotherapy to demonstrate safety and tumor-specific delivery, JX-594 may add significantly to the armamentarium for many solid tumors," stated Andrew R. Haas, M.D., Ph.D., Hospital of the University of Pennsylvania, and investigator on JX-594 Phase 1 trial.
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.
SOURCE Jennerex, Inc.
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