SOUTH SAN FRANCISCO, Calif., June 18 MonogramBiosciences, Inc., (Nasdaq: MGRM) announced today that the Company has signedan agreement with Gilead Sciences, Inc. to provide resistance testing andconsultative services for Gilead's Elvitegravir Phase III studies. Monogramassays will be used to screen patients for study enrollment and help selectdrugs to be given in conjunction with Elvitegravir during the study. BothMonogram's Integrase phenotype and genotype assays were used in Elvitegravirpreclinical and Phase II studies, and will be used to evaluate Phase IIIpatient outcomes. The Phase III studies are anticipated to begin enrollingpatients later this year.
Elvitegravir is the most recent Gilead drug to enter Phase III and is thelatest drug in the promising new class of drugs known as "Integraseinhibitors." Integrase is a viral enzyme that helps HIV integrate its geneticmaterial into a healthy cell's DNA, allowing that cell to begin producinggenetic material for new viruses. Integrase inhibitors block the action ofthis enzyme, interrupting the HIV life cycle before it can begin reproducing.
"Momentum in new ways to combat HIV, such as Integrase inhibitors, isvital to dealing with a virus that is becoming increasingly difficult totreat," said Bill Young, Monogram's chief executive officer. "The Elvitegravirdevelopment program shows the importance of strong collaborations betweendiagnostic and drug makers to more quickly get powerful new treatments intothe hands of those who need them most."
Monogram is a biotechnology company advancing individualized medicine bydiscovering, developing and marketing innovative products to guide and improvetreatment of serious infectious diseases and cancer. The Company's productsare designed to help doctors optimize treatment regimens for their patientsthat lead to better outcomes and reduced costs. The Company's technology isalso being used by numerous biopharmaceutical companies to develop new andimproved antiviral therapeutics and vaccines as well as targeted cancertherapeutics. More information about the Company and its technology can befound on its web site at http://www.monogrambio.com.
About Monogram's Assays
As recommended by the U.S. FDA Antiviral Drugs Advisory Committee,biopharmaceutical companies use HIV resistance testing technology to supportand enhance next-generation HIV drug development. Monogram's proprietarytechnology is being applied to new HIV drug targets for screening and insubsequent clinical development programs for optimization of backgroundtherapy, patient monitoring and, in the case of CCR5 antagonists, for patientselection. Monogram is a leader in providing drug susceptibility and tropismassays for pharmaceutical development. PhenoSense GT(TM) is the only assaycombining actual phenotype and genotype drug results in a single report.PhenoSense GT also includes a measure of replication capacity (RC), sometimescalled viral fitness, and HIV-1 subtype. PhenoSense Entry(TM) is the onlycommercially available phenotypic test for measuring susceptibility to entryinhibitors. Similarly, PhenoSense Integrase(TM), which is a phenotypic testfor measuring susceptibility to integrase inhibitors, is expected to beintroduced commercially soon. Trofile(TM) is a patient selection co-receptortropism assay that determines whether a patient is infected with a strain ofHIV that uses the CCR5 co-receptor, the CXCR4 co-receptor, or a combination ofCCR5 and CXCR4 to enter cells. Trofile is the only clinically validatedtropism assay and has been used to select patients in all phase II and phaseIII studies of CCR5 antagonists to date. Together these assays provide themost complete picture of susceptibility to antiretroviral medications. Theseassays are used by physicians as an aide to guiding therapy selectiondecisions. They are also frequently used by pharmaceutical compan