Jennerex Biotherapeutics has presented clinical data from a phase I / II 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 tumours 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 tumour marker decreases of 65, 80 and 98 per cent.
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 I / II study. These data were presented by David H. Kirn, M.D., CEO and president, 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, European Society of Medical Oncology.
"The survival of many of these patients is remarkable, in particular those who had major tumour 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 IIa clinical trial in the United States for hepatocellular (liver) carcinoma at leading cancer centres including the University of Pittsburgh and the University of California, San Diego. Jennerex is planning to initiate a phase IIa 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. 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," said David H. Kirn, M.D., CEO and president, Jennerex.
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 tumours.
Jennerex Biotherapeutics is a clinical stage biotherapeutics company working to create, develop and commercialise 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.