SAN FRANCISCO and MONTREAL, Sept. 13 /PRNewswire/ -- Jennerex, Inc., a clinical-stage biotherapeutics company focused on the development of first-in-class, targeted oncolytic products for cancer, today reported positive interim data from a pilot trial using JX-594 followed by sorafenib (Nexavar®) to treat liver cancer patients. The data were presented today at the Fourth Annual International Liver Cancer Association Conference in Montreal, Canada.
"While these data represent a small number of patients, we are encouraged by the results, particularly with regard to the promising survival data when compared to historical controls and the fact that all patients to date have exhibited disease control with the treatment regimen of JX-594 followed by sorafenib, including patients whose tumors were previously resistant to sorafenib," said David H. Kirn, M.D., president and chief executive officer of Jennerex. "We expect to report full results from this pilot trial next year and will evaluate the possibility of a larger, randomized clinical trial utilizing this treatment regimen at that time."
The pilot trial has enrolled a total of nine patients to date, a subset of which has failed previous treatment with sorafenib; seven of the nine patients have been evaluated for efficacy. All patients were treated with a combination of intravenous and intratumoral doses of JX-594 followed by sorafenib. Six out of the seven evaluable patients achieved Choi (necrotic) responses, five out of seven evaluable patients exhibited stable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) criteria, and one achieved a partial response by RECIST criteria. In all patients, the treatment regimen was well-tolerated, and sorafenib toxicities were consistent with the documented historical profile. Safety is the primary endpoint of the trial, with a secondary endpoint of disease control rate determined as a response by Choi criteria and/or a response or stable disease by RECIST criteria.
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. 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. Other regional licenses are held by Lee's Pharmaceutical Ltd. for China and Green Cross Corporation for South Korea.
About 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.
Jennerex, Inc. is a clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. The Company's lead product JX-594 is currently in two mid-stage clinical trials in patients with primary liver cancer--an international, randomized, Phase 2 dose-response clinical trial, and a Phase 2 study in combination with sorafenib. Published studies designed to establish optimal dose levels and the safety profile of JX-594 have shown its ability to selectively target a variety of common cancer tumor types. JX-594 and other product candidates under development are designed to attack cancer tumors 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. Jennerex is headquartered in San Francisco and has related research and development operations in Ottawa, Canada and Pusan, South Korea. For more information about Jennerex, please visit www.jennerex.com.
SOURCE Jennerex, Inc.