(Corrects third paragraph to show hold on U.S. trial, not
July 25 Vertex Pharmaceutical Inc said
U.S. health regulators placed a partial clinical hold on its
mid-stage study of an experimental oral hepatitis C treatment
because of potential liver problems, sending its shares sharply
lower on Thursday.
Vertex said the U.S. Food and Drug Administration took the
action on the Phase II study of its VX-135 in combination with
the standard hepatitis drug ribavirin after elevated liver
enzymes were observed in three patients taking the 400 milligram
dose of its drug.
As a result of the hold on the U.S. clinical trial, the
Massachusetts-based biotechnology company said it was unable to
begin dosing patients in a planned U.S. study aimed at testing
VX-135 at 200 mg.
Vertex shares fell 11 percent to $78 in after hours trading
from their Nasdaq close at $87.62.
(Reporting by Bill Berkrot; Editing by Grant McCool)