GlaxoSmithKline Terminates Enrollment into All Phase III Studies
of Experimental CCR5 Entry Inhibitor Aplaviroc
GlaxoSmithKline (GSK) announced today that it is terminating
HIV patient enrollment into Phase III studies of aplaviroc, an experimental HIV CCR5 entry inhibitor. Due to
liver toxicity concerns, no further clinical studies of the drug
are planned at this time. Following is the text of the GSK announcement:
“GlaxoSmithKline
(GSK) announced today that it is terminating patient enrollment
into Phase III studies for the investigational
HIV entry inhibitor, aplaviroc (GSK 873140).
Due to safety data observed in these and the Phase 2b studies,
GSK has taken immediate steps to protect the safety and health
of patients in these clinical studies.
“Aplaviroc is a
CCR5 entry inhibitor which entered Phase III development in July
2005 for the treatment of HIV-1 infection in treatment-experienced
patients. In September 2005, all Phase 2b clinical trials in HIV
treatment-naďve patients, as well as studies in healthy volunteers,
were terminated due to cases of severe
hepatotoxicity.
“Phase III studies in treatment-experienced
patients with multi-drug resistant virus and limited treatment options remained open, although further enrollment
was on hold while data from the Phase 2b studies were reviewed.
Patients who were already in the Phase III studies had the option
to continue therapy and were closely monitored for any adverse events during that time.
“GSK recently received a report of a patient
in one of the Phase III trials who experienced elevated liver enzymes
(AST, ALT) and total bilirubin. Based on a review of this case in the context
of the previous reports from the Phase 2b studies, GSK has stopped
all Phase III studies of aplaviroc.
No further clinical studies of the compound are planned at this
time.
Treatment-experienced
Patients on Aplaviroc Experiencing Clinical
Benefit May Continue on Drug
“It is GSK’s intent
to have all patients stop therapy with aplaviroc.
However, treatment-experienced patients who are currently on aplaviroc and receiving clinical benefit, as determined by
their physician, may elect to continue aplaviroc
therapy until an alternative regimen can be devised or until they
are no longer deemed to be deriving benefit from the drug. These
patients will continue to be monitored closely for signs or symptoms
of liver toxicity or elevations in liver function tests.
“Clinical trial investigators and their Institutional
Review Boards or Ethics Committees have been notified of the situation
and have received instructions for transitioning of patients participating
in the Phase III trials.
“GSK is actively reviewing the aplaviroc safety data, and follow-up on all patients is ongoing.
GSK is committed to excellence in the care of individuals with
HIV infection and remains dedicated to the discovery and development
of new treatment options for HIV, including entry inhibitors.”
10/28/05
Source
GlaxoSmithKline
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