Jennerex, Inc., a clinical-stage biotherapeutics company focused on the development of first-in-class, targeted oncolytic products for cancer, reported positive interim data from a pilot trial using JX-594 followed by sorafenib (Nexavar®) to treat liver cancer patients. The data were presented 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.
About 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.
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.
Source: Jennerex, Inc