A 37-year-old woman who participated in a National Institutesof Health (NIH) clinical trial of an experimental hepatitis B drugdied Tuesday at the University of Virginia Medical Center(UVMC) in Charlottesville, two weeks after receiving a secondliver transplant.

She was the fifth person from the Phase II trial to die.According to a UVMC spokesman, the woman died fromcomplications set in motion by fialuridine (FIAU), a nucleosideanalog that was licensed one year ago by Eli Lilly & Co. ofIndianapolis from Oclassen Pharmaceuticals of San Rafael, Calif.

FIAU was in Phase II clinical testing at the NIH and at twoother sites because it had shown promise in combatinghepatitis B in pilot studies. Lilly suspended the trial on June 26when 10 of the NIH patients who had been treated with FIAUfor 67 to 90 days showed severe adverse side effects. Sincethat time, five of the 10 have died.

Of the survivors, a 63-year-old man remains at UVMC inserious condition after a liver transplant, a 57-year-old manwas discharged from Emory University in Atlanta on Aug. 20after receiving a liver transplant on Aug. 3, and three otherNIH patients have not developed severe side effects.

NIH researchers have theorized that FIAU causes severemitochondrial dysfunction, which leads to liver failure andRintractable lactic acidosis.S Four of the patients who died in thedisastrous Phase II FIAU trial required liver transplants andone was listed for a transplant but was too ill to receive it. Twoof the surviving trial patients have also received livertransplants. -- Lisa Piercey

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