The study (IR101-215), conducted at four sites in Italy, was designed to explore the potential utility of Remune and ongoing analysis will explore immunological information.
The findings focused on data demonstrating stabilization of CD4+ cell counts, which is believed to indicate immune responses against HIV disease in antiretroviral-naive patients treated with Remune.
The analysis showed that median absolute CD4+ cell counts remained stable through week 28 in the patients that received three injections of Remune, with 78% of Remune patients demonstrating a stabilized CD4+ count throughout the course of the trial.
“There is increasing consensus in the HIV medical community that CD4+ counts may be an especially important marker of disease progression,” commented Dr John Bonfiglio, president and CEO of The Immune Response Corporation. “An immune-based therapy like Remune, that could possibly delay initiation of antiretroviral therapy, could be an important advance in the treatment of HIV.”
Remune’s effect on immune reconstitution also suggests a possible mode of action via stimulation of thymus function. The researchers believe that this effect on the thymus may be important in boosting the body’s own defense against HIV. Further research is being carried out to confirm this positive effect on thymus and the circulating lymphocytes phenotypes.
The Immune Response Corporation is planning a clinical program that would use the data from this and other trials to design registration trials in the near future.