-- Data Demonstrate Increased Survival with Full Dose JX-594 in Advanced Liver Cancer Patients -- -- Phase 3 Study to Begin in 2010 --
Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), a clinical-stage cancer biotherapeutics company, today announced the presentation of positive interim data from its randomized Phase 2 clinical trial using JX-594 for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
The study results, presented today by the Principal Investigator Jeong Heo, M.D., Ph.D., and titled "Randomized Phase II clinical trial of intratumoral injection of JX-594, a targeted multi-mechanistic oncolytic poxvirus, in patients with hepatocellular carcinoma," demonstrated increased survival for the full dose JX-594 treated group versus the low dose group (10% of full dose), at both six and 12 months. Based on Kaplan-Meier analysis, the six month survival of patients treated at low dose and full dose was 48% and 75%, respectively and 12 month survival was 18% and 75% for low and full dose, respectively. In addition, the full dose JX-594 group had superior survival when compared to historical controls including patients treated with sorafenib (Nexavar®). The data also showed that, of 17 JX-594 treated patients evaluated after eight weeks, disease was controlled in 15 (88%) patients (objective radiographic response or stable disease). Fifty percent of evaluable patients achieved a Choi (necrotic) response on dynamic contrast-enhanced MRI scan. Treatment was typically associated with transient flu-like symptoms generally lasting less than 24 hours. No patients had treatment discontinued due to toxicities.
"The preliminary data presented today at EASL are very encouraging and validate our clinical experience with JX-594 in patients with advanced HCC who have failed other therapeutic regimens. Patients treated with JX-594 appear to live longer with an improved quality of life," said Dr. Heo. "Because JX-594 works through a three-pronged mechanism of action--attacking cancerous cells through cell lysis, immune stimulation and vascular disruption -we believe it offers a new and promising therapeutic modality for the treatment of liver cancer patients."
Jennerex's Phase 2 clinical trial, which has enrolled 24 patients to date, is evaluating the use of JX-594 to treat patients with advanced, primary liver cancer refractory to standard therapies. The multi-national study is currently enrolling patients at clinical sites in the United States, Canada and South Korea. Patients are randomized to receive JX-594 at one of two dose levels given three times intratumorally at two-week intervals. Primary endpoints of the trial are disease control at eight weeks evaluated by Choi response and Response Evaluation Criteria in Solid Tumors (RECIST).
"We are pleased to be reporting such promising interim results today at EASL, a meeting that attracts leading hepatologists from around the world focused on the discovery of new treatments for hepatocellular carcinoma," said David H. Kirn, M.D., president and chief executive officer of Jennerex. "We look forward to reporting full results from this trial following its completion. We anticipate opening our pivotal Phase 3 clinical trial evaluating JX-594 in combination with sorafenib for first-line therapy of advanced HCC later this year."