Details of Pfizer's Announcement
Pfizer has stated in its announcement that it is communicating these
study results in the interest of ensuring the appropriate use of Selzentry
as it is only indicated for use in treatment-experienced patients infected
with R5- tropic HIV-1. Pfizer has shared the full results of the analysis
with the U.S. Food and Drug Administration (FDA) and intends to submit the
results for presentation at an upcoming HIV medical congress.
Pfizer's announcement acknowledges that:
-- Trofile was the only tropism assay used to screen adult HIV patients
during the Selzentry clinical development program.
-- The safety and efficacy of Selzentry has been shown in treatment
experienced patients who were infected by R5-tropic HIV-1 as determined
by the Trofile assay.
-- Results from one study in patients identified by the Trofile assay as
having D/M-tropic HIV-1 indicated that there was no significant
reduction in viral load when Selzentry was added to optimized
-- The accurate determination of tropism is essential to the appropriate
use of Selzentry.
-- If Selzentry is selected as an active drug for patients infected with
D/M or X4-tropic HIV, it may not contribute to virologic suppression
and could result in emergence of resistance to other drugs in the
Pfizer has stated that physicians who may have made treatment decisions based on the tropism results from the SensiTrop assay and who have questions about this analysis can obtain more information by calling Pfizer at 1 800 879 3477.
Trofile is a patient selection co-receptor tropism assay that
|SOURCE Monogram Biosciences, Inc.|
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