Researchers Publish Promising Results from Cancer Clinical Trial of JX-594 (5/25/2008)

Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), and its South Korean partner Green Cross Corp., announced today that Phase I clinical trial results from its first-in-class lead product JX-594 were published in the premier journal Lancet Oncology. The majority of these end- stage patients with solid tumors had objective tumor destruction and responses following treatment with the cancer biotherapeutic. Half of the JX-594-treated patients survived for more than eight months, well beyond their life expectancies of three to four months, and four patients with tumor responses survived for 11 to over 18 months. Results were especially promising for liver and lung cancer patients. Importantly, treatment with JX-594 was shown to be well-tolerated. A Phase II clinical trial is now underway for JX-594 in liver cancer. The world-wide liver cancer market is estimated at over one billion dollars per year.

"These clinical results with JX-594 are a major step forward for this novel therapeutic approach that Jennerex is pioneering. We are excited by the potential to help the more than ten thousand patients each year who develop liver cancer in the U.S. alone. These desperate patients represent a huge unmet medical need since few effective therapies are available for them. Our team here at UCSD is extremely excited to be a lead site for the current Phase II trial of JX-594 for liver cancer," said Dr. Tony Reid, M.D., Ph.D., Associate Professor and Director of Clinical Investigation at the University of California, San Diego Moores Cancer Center.

"After years of methodical design and development to optimize our products, these results in end-stage patients powerfully validate our commitment to this breakthrough approach. The clinical results were remarkably similar to what we predicted based on extensive lab testing of JX-594. This peer-reviewed publication in a Lancet journal represents a major advance for JX-594 and the rest of our pipeline," said David Kirn, M.D., President & CEO of Jennerex. "We especially want to express our extreme gratitude to the doctors, the patients and their families, and our partners at Green Cross who have all pioneered this treatment with us."

Dr. B. G. Rhee, Executive Vice President, Corporate Development at Green Cross, said "Based on these promising clinical results with our partners at Jennerex, we are in the process of opening the Phase II liver cancer trial at world-renowned liver cancer hospitals in South Korea." Jennerex collaborated closely with medical and scientific research teams in South Korea at Dong-A University and Pusan National University Hospitals, and at the Ottawa Health Research Institute, Ottawa, Canada.

Phase I-II Liver Cancer Study

As reported in the Lancet Oncology publication, 14 patients with a variety of treatment-refractory cancer types (e.g. liver, colon, lung) in the liver were treated every three weeks with JX-594 by ultrasound-guided intratumoral injection. Patients had advanced cancers that had failed all available therapies and were therefore considered terminal. Treatment was well-tolerated during dose-escalation up to the maximum-tolerated dose, with the expected mild to moderate flu-like symptoms; no severe toxicities due to treatment were reported up to these doses. Cancer destruction and objective evidence for efficacy were reported in the majority of patients, including all three with primary liver cancer and patients with lung and colon cancers. Tumor responses were achieved in evaluable patients by objective criteria including RECIST (Response Evaluation Criteria in Solid Tumor) (response in 30 percent of patients, stable disease in 60 percent of patients) and Choi criteria (response in 80% of patients). Tumor responses were associated with long-term survival in many patients, including four who survived for 11 to over 18 months. Mechanism-of-action of JX-594 was validated in patients by demonstration of tumor-specific replication and tissue destruction with JX- 594, in addition to high-level active expression of the GM-CSF protein in the blood of patients. These results led to the initiation of a Phase II liver cancer trial that is now open in the U.S., and will shortly begin enrolling patients at sites in South Korea and Canada, as well.

Note: This story has been adapted from a news release issued by PRNewsWire

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