Positive Interim Results for JX-594 Randomized Phase 2 Liver Cancer Trial Presented at Major International Conference (EASL)
Data Demonstrate Increased Survival with Full Dose JX-594 in Advanced Liver Cancer Patients -- Phase 3 Study to Begin in 2010
San Francisco, California, and Vienna, Austria, April 19, 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."
About JX-594 JX-594 is a cancer biotherapeutic product, currently in Phase 2 trials, 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 both locally and in distant sites in the body. This cycle of JX-594 replication, cancer cell destruction, release and spread is then repeated. Normal cells are not affected by JX-594 resulting in safety and tolerability.
The poxvirus strain backbone of JX-594 has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells. JX-594 was engineered to enhance this natural safety and cancer-selectivity by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. To enhance product efficacy, JX-594 is also engineered to express the GM-CSF protein. GM-CSF complements the cancer cell lysis work of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and an anti-tumoral immune attack.
Jennerex is a clinical-stage biopharmaceutical company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. The company's lead product JX-594, currently in an international Phase 2 trial for primary liver cancer and colorectal cancer, demonstrated promising Phase 1 efficacy and safety results in patients with a diverse array of common cancers. Jennerex's products target, attack and eradicate cancers through a novel and potent oncolytic mechanism that is dependent on highly-specific replication of the company's poxviruses in cancer cells. These products simultaneously stimulate the body's immune response to the cancer. Of note, this mechanism of action and the results in patients to date put the company's product class in a leadership position. Jennerex's therapeutic approach is markedly different from gene therapy and standard cancer vaccine approaches. Jennerex Biotherapeutics was established in San Francisco CA and in Ottawa Canada in 2006 with Dr. David Kirn (CEO) in San Francisco and Dr. John Bell (CSO) from the Ottawa Health Research Institute/University of Ottawa. For more information about Jennerex and the company's robust pipeline and three clinical-stage products, please visit www.jennerex.com.
Jennifer Cook Williams
Cook Williams Communications, Inc.