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.
"Given the efficacy of existing first line treatments, achieving comparable results in this trial is a very positive result for Selzentry and demonstrates the value of Trofile in selecting patients," continued Young. "With this data, physicians can have increased confidence in their patient selection for Selzentry's current indication."
HERmark(TM) Breast Cancer Assay
"Our commercial introduction of HERmark is progressing well," continued
Young. "Our oncology sales team is in place and initial HERmark tests have
been performed for patients determined by existing technologies to be
HER2-negative. As our prior clinical data suggests, these patients include
some who have now been reclassified by HERmark as HER2 positive. Our
commercial goals for HERmark in 2008 are to educate the breast cancer
community on HERmark and to stimulate interest
|SOURCE Monogram Biosciences, Inc.|
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