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www.fdanews.com/articles/81203-immune-response-corporation-to-begin-new-hiv-drug-study-in-italy

IMMUNE RESPONSE CORPORATION TO BEGIN NEW HIV DRUG STUDY IN ITALY

September 27, 2005

The Immune Response Corporation will begin enrolling patients in Italy in a Phase I/II study investigating IR103, the company's newest product candidate for the treatment of HIV.

The randomized, double-blind, comparative, multicenter study will follow patients for 52 weeks. The primary objective is to evaluate safety and bioactivity - the ability to generate HIV-specific immune responses to IR103 - in HIV patients who have not begun active antiretroviral therapy.

The patients will either be newly enrolled or will be returning patients from a previous REMUNE study. Patients previously treated with REMUNE will be assigned across both tracks of the study, enabling analysis of IR103 and REMUNE in this patient population. The IR103 study track will evaluate and compare response to varying doses as well as placebo.