Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene (NYSE Euronext Paris: FR0005175080), a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced that enrollment and treatment of patients in a Phase 1b clinical trial has been initiated to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer (CRC).  The study will be performed in Korea, where Green Cross Corporation holds market rights for JX-594.

"The initiation of this study marks an important step forward in the development of JX-594 for a second major oncology indication. With a significant and growing population of colorectal cancer patients who have failed existing therapies or for whom existing therapies are not appropriate, we believe JX-594, with its unique mechanisms of action and demonstrated tumor response in preclinical models of CRC, may provide an important new therapeutic modality for patients around the world suffering from this devastating cancer," said David H. Kirn, M.D., president and chief executive officer of Jennerex.

"The study design for this trial builds on our joint experience and positive clinical results using JX-594 to treat liver cancer and represents an important milestone which is our ability to administer multiple doses intravenously," added Philippe Archinard, chairman and chief executive officer of Transgene.

The intravenous, open-label, multi-dose-escalation study is being conducted at Samsung Cancer Center in Seoul, South Korea. The study will enroll up to 15 patients with metastatic colorectal cancer that have failed both oxaliplatin-based and irinotecan-based chemotherapy regimens, and whose tumors harbor ras mutations and/ or are refractory to Erbitux therapy. Patients enrolled in the trial will receive biweekly intravenous infusions of JX-594 at one of three dose levels to evaluate the safety, tolerability and maximum tolerated dose of JX-594 for the treatment of CRC.