Jennerex and Green Cross report positive phase 2 JX-594 clinical trial for liver cancer

Apr 21 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 Green Cross Corporation, a leading company in the development, manufacturing, and commercialization of viral vaccines and other biological products, today reported positive clinical data from a Phase 2 trial evaluating JX-594 for liver cancer which was conducted in South Korea.  The data were reported in the journal Molecular Therapy.

Patients enrolled in a Phase 2 clinical trial for hepatocellular carcinoma (HCC) received three intratumoral administrations of JX-594.  A subset of three patients subsequently received sorafenib, the current standard of care for HCC and the only approved systemic therapy for this indication to date.  All three of these patients exhibited rapid and marked tumor necrosis as quantitated by serial dynamic MRI imaging; all patients had both Choi (necrotic) and modified Response Evaluation Criteria in Solid Tumor (mRECIST) type responses.  The responses were rapid—as early as 2.5 weeks after sorafenib initiation—and occurred in both JX-594-injected and non-injected tumors.  Notably, similar responses were not seen in HCC patients treated with sorafenib alone at the same institutions (zero of 15 patients). The treatment regimen was well tolerated in each of the patients, and sorafenib toxicities were consistent with the documented historical profile. The JX-594-sorafenib combination regimen is currently being further investigated in another Phase 2 trial.

"Given the strength of the clinical and preclinical data we have observed from our JX-594 trials in liver cancer, we are planning further clinical trials of JX-594 as a single agent and in combination with VEGFR inhibitors. TRAVERSE, our planned randomized Phase 2b clinical trial of JX-594 used as a single agent, will evaluate survival in advanced HCC patients who have progressed after treatment with sorafenib," stated David H. Kirn, M.D., president and chief executive officer of Jennerex.

"While the subset of patients in this trial is small, the data are quite compelling.  In prior studies we have demonstrated JX-594's ability to induce necrotic responses as a single agent. This is the first publication showing that JX-594 may sensitize tumors to subsequent treatment with VEGFR inhibitors, such as sorafenib," stated BG Rhee, Ph.D., president, Green Cross Corporation.

The publication also highlighted a case report of a complete and durable response in a patient with metastatic renal cell carcinoma (RCC) who received JX-594 in a Phase 1 intratumoral dose-escalation trial.  The patient, who had a baseline life expectancy of less than six months, had locally bulky and widely metastatic RCC.  The patient received four intratumoral injections of JX-594 and subsequently received standard therapy with sunitinib, an approved drug for RCC of the same class as sorafenib.  CT and PET scanning showed a whole-body complete response, and the patient remains alive and disease-free over four years after treatment initiation.  

JX-594

JX-594 is a proprietary, engineered oncolytic virus that is designed to selectively target and destroy cancer cells. JX-594 is designed to attack cancer through three diverse mechanisms of action: the lysis of cancer cells through viral replication, the reduction of the blood supply to tumors through vascular targeting and destruction, and the stimulation of the body's immune response against cancer cells, i.e., active immunotherapy. Phase 1 and Phase 2 clinical trials in multiple cancer types to date have shown that JX-594, delivered either directly into tumors or systemically, induces tumor shrinkage and/or necrosis and is well-tolerated by patients. Objective tumor response has been demonstrated in a variety of cancers including liver, colon, kidney, lung and melanoma.

Transgene (NYSE Euronext Paris: FR0005175080), a bio-pharmaceutical company specialized in the development of immunotherapeutic products, holds an exclusive license to develop and commercialize JX-594 in Europe and neighboring countries. Green Cross Corporation holds an exclusive license to develop and commercialize JX-594 in South Korea, and Lee's Pharmaceutical Ltd. holds an exclusive license to develop and commercialize JX-594 in China.

Liver Cancer and Hepatocellular Carcinoma (HCC)

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third most common cause of cancer-related deaths world-wide with about 660,000 patients dying from the disease annually. Most HCC cases develop on the background of chronic liver cirrhosis; in regions with the highest incidence of HCC, East Asian and African countries, the majority of cases are related to hepatitis B; in developed Western countries and Japan the disease is commonly related to hepatitis C, heavy alcohol consumption and non-alcoholic fatty liver due to metabolic syndromes such as diabetes and obesity. There is accumulating evidence that the incidence of HCC is increasing in Western countries. Despite recent advances, the treatment of advanced HCC remains a significant unmet medical need with a median expected survival under current therapies of less than one year.