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HIV and Hepatitis.com Coverage of the
45th Annual Meeting of the European
Association for the Study of the Liver (EASL 2010)

April 14 - 18, 2010, Vienna, Austria
Gilead Terminates Study of Caspase Inhibitor GS 9450 for Hepatitis C Due to Safety Concerns

SUMMARY: Gilead Sciences announced this week that it will end a Phase 2 clinical trial of its investigational caspase inhibitor, GS 9450, which was being studied as a therapy for chronic hepatitis C, due to "significant laboratory abnormalities and adverse events" in trial participants.

By Liz Highleyman

Researchers presented data from 3 studies of GS 9450 at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) last week in Vienna. One found that the drug had favorable pharmacokinetic properties, and the other 2 showed that GS 9450 reduced alanine aminotransferase (ALT) and levels of cytokeratin 18 (a marker for liver cell apoptosis, or "cell suicide") in patients with hepatitis C and non-alcoholic steatohepatitis (fatty liver disease).

In a brief press statement issued on April 19 (reprinted below), Gilead indicated that an ongoing Phase 2 trial of the drug was being terminated, but the company did not specify what adverse events led to this decision.

According to a Bloomberg News report, Gilead spokesperson Amy Flood said some patients experienced liver damage that was not caused by their underlying liver disease. However, "[s]he declined to specify the number of patients who were harmed and the precise nature of their injuries."

Gilead Terminates Phase II Clinical Trial of GS 9450
in Patients With Chronic Hepatitis C


Foster City, Calif. -- April 19, 2010 -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced the company is stopping its ongoing Phase II clinical trial of GS 9450, an investigational caspase inhibitor, in patients with chronic hepatitis C. This decision follows reports of significant laboratory abnormalities and adverse events in a number of clinical study participants.

Patient safety is Gilead's top priority, and the company has therefore made the decision to halt this study immediately. Gilead will be conducting a thorough review of all available data to assess future clinical development of the compound.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

4/23/10

Sources

Gilead Sciences. Gilead Terminates Study of Caspase Inhibitor GS 9450 for Hepatitis C Due to Safety Concerns. Press release. April 19, 2010.

R Waters. Gilead Stops Hepatitis Drug Trial for Patient Safety. Bloomberg News. April 19, 2010.

References

MP Manns, E Lawitz, AIM Hoepelman, and others. Short term safety, tolerability, pharmacokinetics and preliminary activity of GS 9450, a selective caspase inhibitor, in patients with chronic HCV infection. 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010). Vienna, Austria. April 14-18, 2010. (Abstract 273).

MT Cornpropst, W Liang, GJ Yuen, and others. A drug interaction study evaluating the coadministration of GS-9450, a novel caspase inhibitor, and the fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil fumarate in healthy volunteers. 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010). Vienna, Austria. April 14-18, 2010. (Abstract 745).

V Ratziu, M Chojkier, MY Sheikh, and others. Safety, tolerability and preliminary activity of GS-9450, a selective caspase inhibitor, in patients with non-alcoholic steatohepatitis (NASH). 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010). Vienna, Austria. April 14-18, 2010. (Abstract).


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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