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Jennerex Publishes Clinical Trial Data With Lead Product JX-594 Demonstrating Efficacy Against Liver Cancer and Associated Hepatitis B Virus
Date:7/22/2008

Cancer Center.

"After years of methodical design and development to optimize our products, these results in end-stage liver cancer patients clearly validate our breakthrough product class. The clinical and mechanistic results were predicted based on extensive lab testing of JX-594. This peer-reviewed publication in Molecular Therapy represents a major clinical and scientific advance for JX-594," said David Kirn, M.D., President & CEO of Jennerex. "As always, we thank the doctors, the patients and their families, and our partners at Green Cross who have all pioneered this treatment with us."

Phase I-II Liver Cancer Study

As previously reported, 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. Thes
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SOURCE Jennerex, Inc.
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