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News

Monogram's HIV tropism assay offers HIV treatment benefits

Monogram Biosciences : 18 June, 2008  (Company News)
Monogram Biosciences has released data relating to the enhanced performance of the company's HIV tropism assay which were presented in an oral presentation at the 17th International HIV Drug Resistance Workshop in Sitges, Spain.
Trofile was introduced commercially upon FDA approval of Selzentry (maraviroc), Pfizer's first in class CCR5 antagonist, in August 2007. Recent enhancements to Monogram's Trofile HIV co-receptor tropism Assay have made it substantially more sensitive at identifying minor subpopulations of CXCR4-using virus (X4 or dual/mixed (D/M) tropic) that may portend treatment failure with CCR5 antagonists.

The Trofile Assay is now capable of detecting CXCR4 tropic virus existing at levels as low as, or in some cases lower than, 0.3 percent of the total virus population. At levels of X4 using virus as low as 0.3 percent, Trofile is 100 percent sensitive.

'The CCR5 antagonist class of drugs has become an important addition to the choice of therapies for treatment of HIV,' said Eric Daar, MD, chief of HIV Medicine at Harbor-UCLA Medical Center. 'Selecting the right patients is critical, not just for the appropriate use of CCR5 antagonists but also to protect the other drugs in the patient's regimen from unnecessary exposure to the development of resistance. The availability of Trofile with enhanced sensitivity now provides further confidence for physicians that treatment choices can be properly assessed.'

In an oral presentation during the session on ‘New Resistance Technologies and Interpretations’, Monogram scientist Dr Jacqueline Reeves presented an analysis of subjects from the AIDS Clinical Trials Group 5211 (ACTG 5211) study. ACTG 5211 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 the 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 less than 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, PhenoSenseGT and GeneSeq 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, is not only a part of patient selection for clinical trials, it is also critical to the pre-clinical evaluation of new drug candidates and for optimizing the selection of approved treatments for patient management in routine clinical practice.

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