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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

To: Izzy who wrote (5620)	11/2/1998 4:10:00 PM
From: Steve Fancy	Read Replies (1) \| Respond to of 6136

FDA Panel Backs Glaxo Wellcome's Ziagen For HIV/AIDS Dow Jones Newswires By Otesa Middleton WASHINGTON (Dow Jones)--A federal panel gave its support to Glaxo Wellcome Inc.'s fourth anti-AIDS drug, Ziagen. The panel endorsed the treatment Monday for both adults and children in pill and liquid form. The final decision on the drug will come from the U.S. Food and Drug Administration, which usually follows the advice of the outside expert panels it convenes. Ziagen, which has been designated for an expedited, conditional approval because it treats a life-threatening disease, will have to come back to the agency once it has finished all of its trials to ask for full approval. FDA asked its Antiviral Drugs Advisory Committee to review Ziagen because the agency was concerned about cases of hypersensitivity to the drug, which may result in death, said Dr. Heidi M. Jolson, director of the FDA's division of antiviral drug products. Jolson said the agency also wanted the committee to discuss Ziagen's pediatric data and one of Glaxo's proposed drug combination regimens for the drug. Dr. Stephen LaFon, Glaxo's project leader for Ziagen, presented the panel with the results of four Ziagen studies. One study, of 173 adults who hadn't previously been treated with anti-AIDS therapy, randomized patients to receive either Ziagen in combination with 3TC and AZT or a placebo with 3TC and AZT. Glaxo said the study found the Ziagen regimen was twice as effective in reducing the amount of HIV levels. In the next study, 205 children who previously had been treated were randomly assigned to receive Ziagen with 3TC and AZT or a placebo with 3TC and AZT. The study showed Ziagen worked similarly in children as it did in adults, said LaFon. The pediatric study found that Ziagen performed better than 3TC and AZT alone, LaFon said. Also, Glaxo presented information on Ziagen in 99 adults with AIDS-related dementia. LaFon said patients were given Ziagen or a placebo, both in addition to their current treatment. Both groups of patients improved, so Glaxo didn't apply to have the drug approved as a treatment for AIDS-related dementia. The fourth study involved 562 adults who hadn't been previously treated. Patients were randomly assigned to receive Ziagen with 3TC and AZT or a standard cocktail of Merck & Co.'s (MRK) protease inhibitor Crixivan, 3TC and AZT. LaFon said the preliminary results of the study just became available in October and Glaxo hadn't yet revealed to investigators or patients which patients were receiving which treatment. The preliminary results showed that the treatment combinations were producing virtually identical results in reducing HIV levels in patients and in elevating counts of CD4 cells, the noninfected cells that help fight off the virus, LaFon said. Glaxo also conducted several other trials that showed Ziagen can be safely administered in combination with other commonly used AIDS therapies, LaFon said. Dr. Seth Hetherinton, Glaxo's senior clinical research physician, said the most common adverse reactions occuring in adult and pediatric patients taking Ziagen were nausea, vomiting, diarrhea, fatigue and headache. The company said the drug worked equally well regardless of gender or race.

To: Izzy who wrote (5620)	11/2/1998 4:11:00 PM
From: Steve Fancy	Respond to of 6136

Maybe my imagination, but sure seemed like AGPH went positive on the day when the previous story hit the wires. Also FWIW, IMNR up 12.76% to 13 13/16. Anyone have an opinion whether Remune is actually doing this, something else drug related, or potential buyout enthusiasm? sf