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Data Reported at ICAAC Indicates Selzentry(TM) Phase III Treatment-Naive Trial Shows Increased Efficacy When Used With Enhanced Trofile(TM) Assay
Date:10/26/2008

nal samples from the MERIT trial using the enhanced Trofile assay. These samples had been previously archived by Monogram and laboratory personnel had no knowledge of previous testing results or clinical outcomes data from the trial. The results obtained with the enhanced sensitivity version of the Trofile Assay were provided to Pfizer who conducted the clinical analysis in accordance with a prespecified statistical analysis plan.

Using the enhanced Trofile assay, 15% of MERIT screening samples previously defined as R5 HIV were reclassified as CXCR4-using (Dual/Mixed) HIV, and thus would have been unable to participate in the study. Analyses restricted to individuals with CCR5-tropic HIV as determined by the enhanced Trofile assay demonstrated an overall improvement in Selzentry efficacy relative to efavirenz (the control arm of the trial). In the new retrospective analysis of the MERIT trial samples, powered by the enhanced Trofile assay, 68% of individuals achieved HIV-1 RNA <50 copies/mL at week 48 in both the Selzentry and efavirenz arms of the study.

"The data presented this week demonstrate the value of selecting the appropriate individuals for Selzentry therapy," said William Young, Monogram CEO. "With proper patient selection, using Trofile, a positive response to therapy can be expected, even in early stage individuals where the standard of care is already very high. Monogram's commitment to scientific excellence is clearly reflected in the data presented this week, which provides increased hope for individuals infected with HIV that new classes of drug and new drugs, such as Selzentry, may benefit all HIV infected individuals, not just those individuals with advanced disease."

"Selzentry already has a proven record as a safe and effective therapeutic option for treatment-experienced HIV positive patients," said W. David Hardy, MD, Director, Division of Infectious Diseases at Cedars-Sinai Medical Center and Associate Professor of Medici
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SOURCE Monogram Biosciences, Inc.
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