Jennerex, Transgene present JX-594 Phase 1 and 2 study data in liver cancer at EASL meeting

Apr 5 2011

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene (NYSE Euronext Paris: FR0005175080), a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced that new data from Phase 1 and 2 clinical studies of JX-594 were presented in an oral presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) over the weekend at the Internationales Congress Centrum in Berlin, Germany.

The data from abstract #LB-283, entitled "JX-594, A Targeted Multi-Mechanistic Oncolytic Poxvirus, is Well-Tolerated and Exhibits Anti-Tumor Activity in Patients with Primary Liver Cancer and Liver Metastases," were presented by Caroline Breitbach, Ph.D., director of translational research.

"We are pleased to present these data on JX-594 at the EASL meeting, as they provide further evidence that both primary liver cancer and metastases to the liver can be treated safely with JX-594, with transient flu-like symptoms being the most common adverse events.  Anti-cancer activity continues to be clearly demonstrated in a broad spectrum of common solid tumor types," said David H. Kirn, M.D., president and chief executive officer of Jennerex.

"We look forward to reporting additional clinical results in patients with advanced liver cancer from two ongoing studies—a randomized Phase 2 trial of JX-594 evaluating survival across two dose groups, and a Phase 2 clinical trial evaluating JX-594 in combination with sorafenib," added Philippe Archinard, chairman and chief executive officer of Transgene.

Clinical Results

This presentation highlighted data from 35 patients with either primary liver cancer, known as hepatocellular carcinoma (HCC), or cancer metastases to the liver (including colorectal cancer, melanoma and renal cancer).  All patients were given intratumoral (IT) injections (up to eight treatments) over the course of JX-594 therapy.  Twenty-three patients (66%) exhibited significant tumor necrosis and responses by modified Choi criteria (decreased tumor density). Choi responses have also been documented in non-injected tumors, consistent with prior data on JX-594.  Seven patients (20% of evaluable) also exhibited objective response by Response Evaluation Criteria in Solid Tumor (RECIST) criteria, including two complete responses upon long-term follow-up. Twenty patients (57%) had stable disease as defined by RECIST criteria.

SOURCE Jennerex, Inc.