Safety concerns force Gilead to halt mid-stage hep C trial

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Gilead (NASDAQ: GILD) has slammed the brakes on a mid-stage clinical trial of an experimental therapy for hepatitis C after it picked up "reports of significant laboratory abnormalities and adverse events in a number of clinical study participants."

The company announced yesterday evening that it had decided to halt the study and assess the data on GS-9450. But aside from a terse statement, there was precious little information to glean about the program. A spokesperson for the Foster City, CA-based developer declined to tell Bloomberg how many patients had been hurt or the kind of adverse events that were recorded.

On its website Gilead lists GS-9450 as a caspase inhibitor that's also in Phase II for nonalcoholic steatohepatitis. Just a few days ago researchers announced that that Phase II study had produced promising data on the drug's ability to inhibit proteins responsible for triggering apoptosis, or cell death.

"It is encouraging to see that GS-9450-associated reduction of apoptosis and cell damage seen in animal models has translated to a significant patient population, and seems to be consistent with a good tolerability profile in patients from a variety of countries," Professor Fabio Marra told the International Liver Congress.

- here's Gilead's press release
- here's the Bloomberg story

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