California, USA-based immunopharmaceutical firm Immune Reseponse says that the preliminary results from a Phase II trial of Remune (gp120-depleted HIV-1 immunogen) and IR103, its first- and second- generation HIV vaccine candidates, show that both drugs stabilize CD4+ T cell counts to a greater extent than placebo in patients who have not experienced antiretroviral therapy.
The findings, which are taken from week 36 of a year-long safety and immunogenicity study that is expected to conclude in 2008, show a clear trend towards stable CD4+ T cell counts between weeks 24 and 36. IR said, however, that it would not undertake a statistical analysis of the data prior to completing the program.
Joseph O'Neill, the firm's chief executive, explained that the interim results were encouraging because they mirror the observations of an earlier 28-week assessment. He added that they "suggest that this effect [CD4+ stablization] is reproducable and can sustained for at least 36 weeks." The firm noted that it intends to present the interim data at an, as yet unspecified, medical conference in the middle of the year.
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