The trial demonstrated 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%.
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. JX-594 was also well tolerated in the Phase I and II study.
Following on these results, Jennerex is initiating a phase IIa clinical trial in the US 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 IIa for squamous cell head and neck cancers in early 2008.
David Kirn, CEO and president of Jennerex, said: “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.”