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Biotech / Medical : Indications -- HIV

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To: tuck who wrote (10)10/25/2005 2:59:35 PM
From: tuck  Read Replies (2) of 155
 
[GSK/Ono -- CCR5 inhibitor fails for 2nd time on side effects; GSK pulls plug]

Things are not looking so good for this class, now . . . Pfizer's trial has been under criticism for similar reasons.

>>TOKYO, Oct 25 (Reuters) - Japan's Ono Pharmaceuticals Co. Ltd. (4528.OS: Quote, Profile, Research) said on Tuesday GlaxoSmithKline Plc. (GSK.L: Quote, Profile, Research) has ended all phase three studies of experimental AIDS drug aplaviroc, which was licensed from Ono, after a patient developed side-effects.

GSK, the world's largest maker of HIV/AIDS drugs, terminated in September its Phase IIb tests of the product on so-called "treatment-naive" patients, or those who had not received other HIV therapies.

Glaxo, however, had offered treatment-experienced patients the option of continuing in a Phase III study, but with additional monitoring for liver toxicity.

GSK, however, recently received a report that a patient in one of the phase three studies experienced an elevation of liver enzymes and total bilirubin and decided to stop all phase three 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.

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.<<

Cheers, Tuck
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