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news.GlaxoSmithKline has stopped all end-stage studies of the experimental AIDS drug aplaviroc, originally licensed from Japan's Ono Pharmaceuticals, following evidence that the product may increase the risk of liver damage.
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The companies were already aware that there was a possibility the drug may cause liver abnormalities and had ended previous phase II studies being conducted in treatment-naive patients, choosing to continue to phase III trials only in patients experienced to treatment. The precautionary measure of additional liver monitoring for toxicity was also undertaken.
The decision to halt testing altogether followed a report that one of the patients in a phase III study had experienced an elevation of liver enzymes and total bilirubin. No further studies had been planned for the experimental drug, which is part of a new class of oral medicines called CCR5 inhibitors thought to prevent the AIDS virus by blocking its pathway to human cells.
The companies have said they are now evaluating what to do with aplaviroc and expect to make a decision on its development in the next few months.