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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

Study Demonstrates Feasibility and Efficacy of Treating Patients with

Primary Liver Cancer

SAN FRANCISCO, and YONGIN-SI, South Korea, July 22 /PRNewswire/ -- Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), and its South Korean partner Green Cross Corp., announced today that novel findings from a Phase I clinical trial of its first-in-class lead product JX-594 demonstrated that the product was well-tolerated and resulted in clear anti-cancer efficacy in patients with liver cancer. Three patients with advanced treatment-refractory hepatitis B virus (HBV)-associated hepatocellular carcinoma (HCC) were treated with JX-594. Objective radiographic responses were demonstrated. Serum tumor markers, which correlate with tumor burden over time in patients, decreased by up to 95 percent after treatment. JX-594 replication, its release into the circulation and distant tumor targeting and infection were demonstrated. JX-594 administration resulted in tumor vascular shutdown. Oncolytic virotherapy was also shown, for the first time, to suppress underlying HBV replication in HCC patients by over 50 percent in all three patients. A Phase II clinical trial is now underway for JX-594 in liver cancer. The data were published in the journal Molecular Therapy.

"These clinical results with JX-594 in end-stage liver cancer patients represent a major step forward for JX-594 against this difficult to treat cancer. We are excited by the potential to fulfill the huge unmet medical needs for these desperate patients with no curative treatment options, specifically by treating their tumors and potentially their underlying Hepatitis B viral infection. As a lead site for the on-going Phase II trial of JX-594 for liver cancer, we look forward to extending these results in a larger number of patients," 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 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. 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.

About JX-594

JX-594 is a cancer biotherapeutic, currently in Phase II trials, from a proprietary class of targeted and armed oncolytic poxviruses. Tumor destruction and safety was shown in patients with diverse cancer types in three Phase I trials; treated patients were end-stage and had no effective therapies available. JX-594 multiplies selectively within cancer cells, leading to their destruction. These newly created copies of JX-594 are then released and are able to infect and eradicate other tumor cells both locally and in distant sites in the body. This cycle of JX-594 replication, cancer cell destruction, release and spread is then repeated. Normal cells are not affected by JX-594 resulting in safety and tolerability. The poxvirus strain backbone of JX-594 has been used safely in millions of people as part of a worldwide vaccination program against smallpox. This strain naturally targets cancer cells due to common genetic defects in cancer cells. JX-594 was engineered to enhance this natural safety and cancer-selectivity by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. To enhance product efficacy, JX-594 is also engineered to express the GM-CSF protein. GM-CSF complements the cancer cell lysis work of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and an anti-tumoral immune attack.

About Jennerex

Jennerex is a clinical-stage biopharmaceutical company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. The company's lead product JX-594, currently in an international Phase II trial for primary liver cancer, demonstrated promising Phase I efficacy and safety results in patients with a diverse array of common large market cancers. Jennerex's products target, attack and eradicate cancers through a novel and potent oncolytic mechanism that is dependent on highly-specific replication of the company's poxviruses in cancer cells. These products simultaneously stimulate the body's immune response to the cancer. Of note, this mechanism of action and the results in patients to date put the company's product class in a leadership position. Jennerex's position is in marked contrast to gene therapy and standard cancer vaccine approaches. For more information about Jennerex and the company's robust pipeline and three clinical-stage products, please visit http://www.jennerex.com.

About Green Cross Corporation

Green Cross is a leader in the Korean biotechnology and pharmaceutical industries. Green Cross is now an internationally recognized biotechnology company developing several vaccines and therapeutic proteins. Green Cross will become the only seasonal influenza vaccine manufacturer in South Korea and also is developing avian influenza vaccine. In its vaccine business, Green Cross has successfully developed one of the earliest vaccines against Hepatitis B (Hepavax), the first Epidemic Hemorrhagic Fever vaccine and the world's second chicken pox vaccine. Green Cross is developing anticancer drugs such as Greenstatin (anti-angiogenic peptide) and modified PEG-G-CSF for neutropenia.


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SOURCE Jennerex, Inc.
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