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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (2500)	9/18/2005 8:29:06 AM
From: rkrw	Read Replies (1) \| Respond to of 3044

Glaxo Stops Giving AIDS Drug To Newly Diagnosed HIV Patients By MARILYN CHASE Staff Reporter of THE WALL STREET JOURNAL September 16, 2005 7:54 p.m. GlaxoSmithKline PLC halted giving an experimental AIDS drug to newly diagnosed patients with human immunodeficiency virus (HIV) after two of them developed severe liver toxicity. In a statement to the HIV-patient community, Glaxo disclosed that data from safety and efficacy studies of the drug aplaviroc included "reports of severe hepatotoxicity," or liver toxicity, in a subgroup of volunteers known as "treatment-naïve" because the drug was the first AIDS treatment they had received. Glaxo spokesman Rick Koenig said two out of the 250 treatment-naïve patients taking the experimental drug experienced severe liver problems. "We don't know that this was drug related but in the interests of safety we took the actions," he said in an interview. There were no deaths in the study, he added. The studies were being conducted in the U.S., Canada and the European Union. Aplaviroc is one of a next generation of experimental AIDS treatments known as entry-inhibitor drugs because they block a co-receptor on cells, called CCR5, that is used by the virus as a portal of entry. As previously reported, European AIDS activists criticized Pfizer Inc.'s rival CCR5 blocker tests, arguing it was inappropriate to expose newly-diagnosed patients to the risks of an experimental drug when they could benefit from standard drugs. In Glaxo's clinical trial, the patients were receiving aplaviroc in addition to standard therapy for treating HIV. Another 50 patients in a control group received standard therapy alone. Glaxo said it took the step of terminating that portion of its trials involving treatment-naïve patients after discussions of risks with the U.S. Food and Drug Administration. The company added in a statement given to the HIV patient community that it also "has taken immediate steps to protect the welfare of patients in clinical studies of aplaviroc." That includes increased safety monitoring of the patients still receiving the drug, who aren't "treatment naïve," and whose virus has developed resistance to some other AIDS treatments. Glaxo said it is "proceeding cautiously" to continue studies of the drug in these 40 "treatment-experienced HIV patients." However, the company will forgo a planned expansion of that study until it knows more about the extent of the liver toxicity. Half of the 40 are receiving aplaviroc and half are in the control group. The company said it's also revising the informed consent form to reflect the potential new side effects. However, American activists worry that liver damage in the newly-diagnosed may well indicate broader risks endangering other patients. "It may be the death knell for GSK's entry inhibitor," wrote Martin Delaney, founder of Project Inform, an activist group in San Francisco in an email. "It may be a warning about the whole class of drugs. Right now GSK is saying the problem is only in the naive population. But there is virtually no medical logic for this to be the case." Glaxo's Mr. Koenig disagreed in an interview, saying, "Right now it's too early to speculate." He stressed that Glaxo isn't saying that the side effects are limited only to one group of patients. Rather, he said Glaxo halted the trial only in naïve patients because they have other drug options. The trial in experienced patients will continue, he said, because the volunteers with multiple drug-resistance have fewer options were allowed to continue the study if they sign the revised informed consent documents.