Immune Response's phase 2 study of IR103 for HIV to include sites in France

By Lisa Kerner

Charlotte, N.C., Aug. 1 - The Immune Response Corp. said it has approval to expand its phase 2 IR103 study in drug-naive HIV patients, currently ongoing in Italy, to include clinical sites in France.

The trial is expected to enroll more than 200 patients in two parallel clinical studies to examine the second-generation immunotherapy as a first-line treatment for drug-naive HIV-infected individuals not recommended for antiretroviral therapy.

Immune Response's trial will also measure changes in CD4+ counts, a critical marker of HIV disease progression that helps determine when a patient should begin antiretroviral therapy.

In addition to France and Italy, the trial will also include sites in Canada and the United Kingdom, the company said.

"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," vice president of clinical development Georgia Therofan said in a company news release.

HIV claims more than 3.1 million lives annually, according to the news release.

Based in Carlsbad, Calif., Immune Response develops products to treat autoimmune and infectious diseases.

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