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news.Polydex Pharmaceuticals has completed a clinical trial using rhesus monkeys. This new trial was commenced with the objective to try and understand why Ushercell had not shown effectiveness in the trials with women.
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In this trial, two groups of six rhesus macaques each were treated intravaginally with 2ml of HEC-based universal placebo or 6% Ushercell gel (the same clinical formulas used in the Phase III trials) and challenged 30 minutes later with a mixture of R5 and X4 tropic simian-human immunodeficiency viruses (SHIV). The gel/virus exposures were repeated at weekly intervals for up to 13 weeks and infection monitored for 24 weeks after the first exposure to the virus.
While five of six macaques were infected in the placebo group, none of the animals in the Ushercell gel group were infected. This data suggested that consistent vaginal application of Ushercell gel effectively reduced the infectivity of the virus, significantly decreasing the rate of vaginal mucosal SHIV transmission following repeated virus exposures.