Jennerex presents positive preliminary data from JX-594 Phase 2 trial for advanced liver cancer

May 20 2011

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the design, development and commercialization of first-in-class targeted oncolytic products for cancer, today presented preliminary data from a randomized dose-ranging Phase 2 trial of JX-594 in patients with advanced liver cancer showing a benefit in overall survival for the high dose group.  The preliminary data from the study HEP007 indicated that the risk of death for patients who received JX-594 at the high therapeutic dose was markedly reduced by more than 50 percent (hazard ratio < 0.5) when compared to patients randomized to a control low dose (one-tenth of the high dose). Clinical investigators enrolled approximately 30 patients at sites in the United States, Canada and South Korea.

The data were presented by David Kirn, M.D., president and chief executive officer of Jennerex, today in an oral presentation in the Presidential Symposium of the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in Seattle, Washington.  These data were also chosen for inclusion in ASGCT's Media Event to be held during the annual meeting.  Jennerex and its partners expect to present further follow-up on the complete trial data set at a medical conference later this year.

A randomized, placebo-controlled Phase 2b clinical trial of JX-594 in patients with hepatocellular carcinoma (HCC) having failed sorafenib-(Nexavar®) treatment is planned for initiation in the second half of this year; this trial (TRAVERSE), conducted globally with Jennerex's partners, will evaluate survival in advanced HCC patients who have either progressed or exhibited intolerance after treatment with sorafenib, the current standard of care.

"We are extremely encouraged by the promising overall survival results presented today. These results are consistent with a clinically meaningful survival benefit in patients with advanced liver cancer.  Given the large global unmet need in this patient population, we are confident to proceed into larger late-stage trials in advanced HCC patients with JX-594," stated Dr. Kirn.  "If a statistically-significant survival benefit with JX-594 is confirmed in larger randomized trials in HCC patients, JX-594 could represent a major new treatment option for these patients."