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FDA
Grants Fast Track Designation to VX-950, an Experimental Oral
Hepatitis C Virus Protease Inhibitor from Vertex
Vertex
Pharmaceuticals announced that the US Food and Drug Administration
(FDA) has granted Fast Track designation to VX-950,
an experimental oral hepatitis C virus (HCV) protease inhibitor
for the treatment of chronic HCV infection.
Fast
Track designation indicates that FDA will speed up the development
and expedite the review of promising experimental drugs for
the treatment of a serious or life-threatening condition if
it shows the potential to address an unmet medical need for
such a condition.
VX-950
has the potential to shorten the duration of therapy compared
to the standard of care (peginterferon alfa plus ribavirin), which may result in improved sustained virologic
response (SVR) rates and
a more favorable adverse
event profile.
Vertex
is currently conducting a clinical development program to
assess whether VX-950 will address these unmet medical needs
in HCV therapy.
VX-950
Clinical Status
Earlier
in 2005, Vertex concluded a 14-day, Phase
Ib study
of VX-950
that showed a rapid and dramatic reduction in HCV RNA in HCV
patients when VX-950 was administered as a single agent.
Overall
in the Phase Ib study, adverse events
observed in patients receiving VX-950 that were considered
possibly related to the drug were mild, and generally similar
in frequency to events in the placebo group. The most common
adverse events reported in both placebo and VX-950 patients
were headache, frequent urination and gastrointestinal symptoms.
Based
on these encouraging Phase Ib
clinical results, Vertex recently initiated two additional
clinical studies with VX-950. In October 2005 in Europe,
Vertex began a 20-patient Phase Ib
study of VX-950
dosed in combination with pegylated interferon.
In
December 2005, Vertex initiated in the United States the first Phase II study
of VX-950, which will evaluate the safety, tolerability and
pharmacodynamics of VX-950 when dosed with pegylated interferon and ribavirin.
Vertex
expects to obtain results from both these Phase Ib
and Phase II studies of VX-950 in early 2006. Vertex also
expects to initiate multiple additional Phase II studies in
the United States in 2006, including a
three-month study in more than 200 treatment-naive patients.
Other
HIV and Hepatitis.com Articles on VX-950
12/09/05
Source
Vertex Pharmaceuticals. FDA Grants Fast Track Designation to Vertex’s Investigational
Oral Hepatitis C Virus Protease Inhibitor VX-950. Press Release. December 8, 2005.
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