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."
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.
Sciences. Gilead Terminates Study of Caspase Inhibitor GS 9450
for Hepatitis C Due to Safety Concerns. Press release.
April 19, 2010.
Waters. Gilead Stops Hepatitis Drug Trial for Patient Safety.
Bloomberg News. April 19, 2010.
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
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
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).