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Sensitivity Enhancements to Monogram's Trofile(TM) Assay Demonstrate Improved Power to Select Patients for CCR5 Antagonist Therapy
Date:6/16/2008

was a phase II study of Schering Plough's CCR5 antagonist, vicriviroc, in highly treatment experienced HIV patients. This new analysis compared treatment outcomes based on the prospective selection of patients with R5 tropic virus by the original Trofile test versus treatment outcomes based on the re-classification using the enhanced version of the assay.

The ACTG 5211 study enrolled subjects who had R5 virus at screening as determined by the original Trofile assay. The analysis reported at this week's workshop demonstrated that recent enhancements to Trofile enable the assay to further optimize patient selection for CCR5 antagonist treatment by successfully identifying patients that experienced reduced virologic response to vicriviroc. In the patients originally identified as R5 tropic, based on test results obtained with the newly enhanced sensitivity of Trofile, greater reductions in viral load were observed in vicriviroc recipients confirmed to have pure R5 virus populations (1.95 log reduction at week 24) compared to those newly re-classified as having minor subpopulations of CXCR4-using virus (0.57 log reduction at week 24) (P<0.001).

Additional work described at the meeting focused on the use of Monogram's phenotypic and genotypic technology to identify specific markers of HIV resistance to new drug targets/classes. Monogram has assays in advanced development that accurately assess resistance to CCR5 antagonists such as maraviroc (Selzentry, Pfizer) and vicriviroc (Schering-Plough), and integrase inhibitors such as raltegravir (Isentress, Merck) and elvitegravir (Gilead Sciences).

Trofile, incorporating sensitivity enhancements, together with PhenoSense(TM), PhenoSenseGT(TM) and GeneSeq(TM) HIV drug resistance assays constitute Monogram's portfolio of assays for the optimization of antiretroviral therapy for HIV infection. Determining a patient's HIV profile at the molecular and phenotypic level, and the effect of therapy on that profile
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SOURCE Monogram Biosciences, Inc.
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