Sep 13 2010
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.
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