(ChemotherapyAdvisor) – A potential new therapy for patients with metastatic colon cancer that is refractory to chemotherapy has now entered clinical trials. Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class, targeted oncolytic poxvirus-based products for cancer, announced on March 20 that the first patient has been treated in a Phase 1/2 clinical trial of JX-594 in patients with metastatic colorectal cancer who have become refractory to chemotherapy and are either refractory to or ineligible for cetuximab. JX-594 is the most advanced clinical candidate produced by Jennerex to date.
“JX-594, with its three diverse, anticancer mechanisms of action, has shown very strong clinical data to date against multiple tumor types, and it is currently being evaluated in clinical trials for advanced liver and colorectal cancers,” said David H. Kirn, MD, president and chief medical officer of Jennerex. “In the clinical trial announced today, we are particularly interested in observing the effects of the combination of JX-594 with irinotecan given that, in pre-clinical studies, JX-594 has been shown to sensitize tumors to irinotecan, which has the potential to increase its anti-tumor effect in colorectal and other cancers.”
This multicenter study, which will be conducted in the United States, Canada and Europe, has a two-arm, dose-escalation design that will evaluate JX-594 as a monotherapy and in combination with irinotecan in up to 42 patients. Patients in each arm will receive five weekly intravenous infusions of JX-594 at one of two escalating dose levels followed by up to three optional intratumoral injections of JX-594 into metastases to the liver. In the combination arm, patients will be administered irinotecan plus JX-594. Patients will be followed until they have reached endpoints for safety, dose optimization, and tumor responses as measured by RECIST and Choi criteria.