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news.The Immune Response Corporation's lead HIV product candidate, Remune, has been selected for a new HIV clinical trial sponsored by the US National Institutes of Health.
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The National Institutes of Health (NIH) trial is designed to study antiretroviral therapy (ART) alone versus ART with a therapeutic HIV immunization, Remune, in recently HIV-infected people. The study is expected to provide important information about the development of HIV disease and the protective role the immune system may play against HIV disease.
The study will ultimately enroll 92 patients who will receive currently marketed ART drugs for the first 48 weeks of the study followed by administration of Remune or placebo every 12 weeks for an additional 36 weeks. Patients will also undergo structured treatment interruptions following immunization, and will be followed for a minimum of three years.
The Immune Response Corporation believes that results of previous clinical trials demonstrate that Remune boosts HIV-specific immune responses and has the potential to slow the progression of HIV infection when used alone or in conjunction with antiretroviral therapy.
“We are excited that Remune has been chosen for this important study which is designed to observe the effects of therapy in early stages of the disease. Remune is the only immune-based therapy to be studied in this trial,” said Dr John Bonfiglio, president and CEO of The Immune Response Corporation. “We are pleased that previous demonstrations of the ability of Remune to induce strong new immune responses have led to its inclusion in this trial.”