Jennerex initiates JX-594 plus irinotecan Phase 1/2 trial in metastatic colorectal cancer

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic virus products for cancer, today announced 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. The two-arm, dose-escalation study will evaluate JX-594 as a monotherapy and in combination with irinotecan.

The multicenter study will be conducted in the United States, Canada and Europe and is designed to enroll up to 42 patients. Patients will be enrolled in one of two treatment groups—one treatment group will receive JX-594 as a monotherapy and one treatment group will receive JX-594 in combination with irinotecan. Patients in both groups 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. The combination group will receive concomitant administrations of irinotecan. Once the maximum tolerated dose is determined for each treatment group, additional patients will be enrolled at that dose level. The endpoints of the trial include safety, dose optimization, and tumor responses as measured by RECIST and Choi criteria. For more information about the trial, please visit www.clinicaltrials.gov.

"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, M.D., 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."