Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
Reuters NewMedia - October 25, 2005
GSK, the world's largest maker of HIV/AIDS drugs, terminated its Phase IIb tests of the product on "treatment-naive" patients, or those who had not received other HIV therapies, in September.
It had offered treatment-experienced patients the option of continuing in a Phase III study, however, but with additional monitoring for liver toxicity.
But GSK recently received a report that a patient in one of the Phase III studies experienced an elevation of liver enzymes and total bilirubin and decided to stop all Phase III studies of aplaviroc.
Aplaviroc belongs to a new class of oral medicines called CCR5 inhibitors that can block the AIDS virus before it enters human cells.
An Ono spokesman said no further clinical studies of the compound were planned, and the two companies would decide what they would do with the compound within a few months.
"It is GSK's intent to have all patients stop therapy with aplaviroc," Glaxo said in a statement.
"However, treatment-experienced patients who are currently on aplaviroc and receiving clinical benefit ... may elect to continue aplaviroc therapy until an alternative regimen can be devised or until they are no longer deemed to be deriving benefit from the drug," Glaxo added.
The news represents a setback for Glaxo in its race with Pfizer Inc. , which is already more advanced with its rival CCR inhibitor drug, called maraviroc.
Other companies working in the field include Schering-Plough Corp.
Shares in Ono closed down 1.87 percent at 5,250 yen prior to the announcement. That compared with a 0.17 percent drop in the pharmaceutical sector subindex .
Shares in Glaxo were down 1.40 percent at 1,408 pence by 1050 GMT in London.
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Additional reporting by Miyoung Kim in London
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