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Study Reaffirms Superiority of Trofile(TM) Assay

t is both sound and broadly disclosed to the clinical and scientific communities. Trofile is no exception and we are pleased to see comparisons of this sort based on sound scientific analysis."

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

background therapy.

-- 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

treatment regimen.

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.

About Trofile

Trofile is a patient selection co-receptor tropism assay that de

SOURCE Monogram Biosciences, Inc.
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