Positive Results Prompt Phase 2 Trial of JX-594 in Liver and Head and Neck
SAN FRANCISCO, Oct. 23 /PRNewswire/ -- Jennerex Biotherapeutics today presented clinical data from a Phase 1 / 2 trial of JX-594 -- the company's proprietary targeted lytic and immunostimulatory armed virus therapy -- demonstrating objective evidence of efficacy in 10 of the 13 evaluable patients with advanced treatment-refractory tumors in the liver (primary and metastatic). Responses were particularly encouraging in primary liver (HCC) cancers, squamous cell cancers (including lung) and melanoma. All three patients with primary liver cancer had evidence of efficacy, including tumor marker decreases of 65, 80 and 98 percent.
Seven patients survived for at least eight months (double the life expectancy), and four are still alive up to 17 months post-treatment; two are alive over one year. Importantly, JX-594 was shown to be generally well tolerated in the Phase 1 / 2 study. These data were presented today by David H. Kirn, M.D., CEO and President of Jennerex at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference in San Francisco, California.
"We are extremely encouraged by these results, particularly with respect to the effectiveness of JX-594 against liver cancers and squamous cell cancers including lung cancer," said Herbert M. Pinedo, M.D., board member and former president of the European Society of Medical Oncology.
"The survival of many of these patients is remarkable, in particular those who had major tumor responses. This has great promise for many cancer types, starting with liver and head and neck cancers," said the study's principal investigator, Dr. B-H Park, Chief, Interventional Radiology, DAU University, South Korea.
Following on these results, Jennerex is initiating a Phase 2a clinical trial in the United States for hepatocellular (liver) carcinoma at leading cancer centers including the University of Pittsburgh and the University of California, San Diego. Jennerex is planning to initiate a Phase 2a for squamous cell head and neck cancers in early 2008. The company also plans to conduct clinical trials for patients with lung cancer and melanoma.
"The broad clinical efficacy reported by these investigators strongly validates this first-in-class product, JX-594, and its novel mechanism-of-action. These exciting clinical results mirror closely what has been reported in preclinical studies," said David H. Kirn, M.D., CEO and President of Jennerex. "We are extremely grateful for the support of our clinical collaborators, as well as for the sponsorship of our partners for South Korea at Green Cross Corporation."
"We are very pleased to be collaborating with Jennerex for the development of this kind of exciting new drug, JX-594, in Korea," said B.G. Rhee, Ph.D., executive vice president of Green Cross. Jennerex has an exclusive partnership with Green Cross for the South Korean market only.
Jennerex's lead product candidate, JX-594, is a genetically-engineered vaccinia virus strain that is uniquely suited to treat cancers. It is designed to destroy both injected and non-injected metastatic tumors.
Jennerex Biotherapeutics is a clinical stage biotherapeutics company working to create, develop and commercialize first-in-class cancer products. The company's products are engineered viruses that have been modified to be safe and effective against various forms of cancer. Jennerex products seek to kill cancer by targeting, attacking and eradicating cancer cells. The company's lead product candidate, JX-594, demonstrated clear anti-cancer effects in patients in a Phase 1 / 2 clinical trial. A Phase 2a clinical trial for liver cancer is currently being initiated. A Phase 2 trial for JX-594 in squamous cell head and neck cancer is expected to begin in the first quarter of 2008. JX-594 is the first of a novel class of therapeutic products engineered to target, attack and eradicate cancers.
For more information about Jennerex, 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. For more information about Green Cross, please visit http://www.greencross.com.
Ian W. Malone
Chief Financial Officer
|SOURCE Jennerex Biotherapeutics|
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