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GlaxoSmithKline stops phase 3 studies of HIV drug aplaviroc due to safety issues
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10.25.2005, 06:22 AM
LONDON (AFX) - GlaxoSmithKline PLC said it has terminated the phase 3 trials of the HIV inhibitor, aplaviroc, to protect the safety and health of the patients.
Phase 3 trials for aplaviroc, which was in-licensed by GSK in December 2002 from Ono Pharmaceutical Co, started last July.
GSK said it decided to end the studies after one of the patients undergoing the treatment suffered 'elevated liver enzymes and total bilirubin.'
'Based on a review of this case... GSK has stopped all Phase 3 studies of aplaviroc. No further clinical studies of the compound are planned at this time,' it said in a statement.
'It is GSK's intent to have all patients stop therapy with aplaviroc,' it added.
Other patients undergoing the treatment may elect to continue the therapy until an alternative regimen can be devised. They will be monitored closely for signs or symptoms of liver toxicity or elevation in liver function tests, it said.
Glaxo Stops Testing of AIDS Drug on Concerns About Liver Safety 57 minutes ago
Oct. 25 (Bloomberg) -- GlaxoSmithKline Plc, the biggest maker of HIV treatments, halted studies of an experimental AIDS medicine because of concerns it may cause liver damage.
The drug, known as aplaviroc, was in phase III trials, the final stage usually required for regulatory approval. All studies were halted after a patient was found with elevated liver enzymes and total bilirubin, the London-based company said in an e-mailed statement today.
``Clearly we're disappointed but our primary concern is to protect the safety and health of our patients,'' Glaxo spokesman Chris Hunter-Ward said in an interview.
Last month, Glaxo and its partner Ono Pharmaceutical Co., said phase II tests revealed the drug may cause liver abnormalities. The trials were conducted with HIV patients who had never been treated with other drugs for the virus.
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