FDAnews
www.fdanews.com/articles/61492-immune-response-to-expand-hiv-treatment-trial

IMMUNE RESPONSE TO EXPAND HIV TREATMENT TRIAL

August 7, 2006

Immune Response has received approvals to expand its Phase II study of IR103 in drug-naive HIV patients to include clinical sites in France. The trial, which is currently under way at several sites in Italy, will examine IR103, a second-generation immunotherapy, as a first-line treatment for drug-naive HIV-infected individuals not yet recommended for antiretroviral therapy according to current medical guidelines.

Ultimately, more than 200 drug-naive patients will be enrolled in two parallel clinical studies being conducted in France and Italy, and Canada and the UK.

The study, which includes a rollover patient population from a previous clinical study of the company's first-generation immunotherapy, Remune, is designed to assess the safety and ability of various doses of IR103 to induce HIV-specific immunity.