Eli Lilly and Co. announced Wednesday that it has suspendedPhase II clinical trials of fialuridine (FIAU), the nucleosideanalog it licensed from Oclassen Pharmaceuticals Inc. in August1992.

The trials will remain suspended until Lilly determines thecause of the serious adverse events that occurred during thestudy on FIAU's ability to treat chronic hepatitis B infection.

Several of the 20 hepatitis B-infected individuals enrolled inthe three-site trial "experienced adverse effects ranging fromnausea, vomiting and numbness to liver or kidney failure,"explained Suzanne Simala, a Lilly corporate spokeswoman. Allpatients who had received the therapy are being closelymonitored at this time, Lilly said.

Until the data are analyzed, it's not clear whether the adversereactions shown by some patients were caused by the drug orby their existent disease, said Glenn Oclassen, chairman ofOclassen Pharmaceuticals of San Rafael, Calif.

"The patients were very sick to begin with. All of them for onereason or another were not candidates for interferon, the onlyapproved therapy for hepatitis B," he told BioWorld. "It will bea few months before we understand what's going on." --Jennifer Van Brunt

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