FDA OK's higher dose of Starpharma's VivaGel
Tuesday, 03 August, 2004
Starpharma (ASX: SPL) will move to the next stage of the Phase I clinical trial for its nanodendrimer-based vaginal microbicide VivaGel, after the US FDA approved a dose increase based on the interim trial results.
After no serious adverse events were noted in patients receiving doses of the gel containing 0.5 or 1.0 per cent of the active ingredient, the company has been given the go ahead to increase the dose to 3.0 per cent.
The study is being conducted in Adelaide by CMAX, a division of the Institute for Drug Technology (IDT).
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