Jennerex commences enrollment in JX-594 Phase 2b trial for HCC

Nov 4 2011

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic virus products for cancer, together with its international commercialization partners, today announced that enrollment has been initiated and the first patient has been randomized in a Phase 2b clinical trial called TRAVERSE.  The trial is evaluating the use of JX-594 to treat patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC), who failed prior therapy with sorafenib (Nexavar®), the only approved drug for advanced HCC.  In addition, Jennerex earned a milestone payment from its development and commercialization partner, Transgene, based on the randomization of the first patient in the TRAVERSE clinical trial.

"JX-594, with its targeted, multi-mechanistic approach, could offer liver cancer patients a distinct therapeutic alternative, even after they have failed all approved treatment options," stated David H. Kirn, M.D., president and chief medical officer of Jennerex.  "We are building on the positive results of our recent Phase 2 clinical trials evaluating JX-594 in advanced liver cancer both as a single agent and as followed by sorafenib (Nexavar®)."

The TRAVERSE Phase 2b clinical trial is designed to enroll 120 patients with advanced liver cancer who have failed sorafenib therapy. The randomized study will be conducted at approximately 45 sites worldwide including North America, South Korea, Taiwan, Hong Kong, and Europe. The primary objective of the trial is to determine the overall survival benefit for patients receiving JX-594 with best supportive care, compared to best supportive care alone in patients with refractory advanced liver cancer. was observed in six of seven evaluable sorafenib resistant patients (86 percent).