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news.The Immune Response Corporation has received approvals to expand its phase II study of IR103 in drug-naive HIV patients to include clinical sites in France.
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The trial, which is currently ongoing 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.
“We are very pleased to have obtained regulatory approval to expand our IR103 study into France,” said Dr Georgia Theofan, vice president of clinical development. “The enrollment of additional patients in Europe will allow us to generate important data on IR103’s role in stabilizing CD4+ cell counts in HIV drug-naive patients.”
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.