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Shionogi-ViiV Healthcare LLC Initiates Phase III Clinical Programme for Investigational Once-Daily HIV Integrase Inhibitor

Thu, 10/21/2010 - 1:32am
Bio-Medicine.Org

LONDON, Oct. 21 /PRNewswire/ -- Shionogi-ViiV Healthcare LLC today announced the start of the Phase III clinical programme evaluating its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572). The Phase III clinical programme, which began this month, includes two studies (SPRING-2 and SAILING) that will evaluate '572 in both treatment-naive patients and treatment-experienced, but integrase-naive patients.

"Progression of one of our lead pipeline compounds into late stage development for use in treatment-naive and treatment-experienced patients is an important milestone for ViiV Healthcare in its first year and ultimately we hope for those living with HIV. We believe that this clearly demonstrates the benefit of our 100% focus on HIV and commitment to delivering new or improved treatment options," stated Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare.

"We are pleased to see '572 progressing into Phase III clinical trials and are optimistic about its potential for HIV-infected patients," said Dr. Sapan Shah, President & CEO, Shionogi Inc. "As the only once-daily, unboosted integrase inhibitor in Phase III clinical development, '572 may help address certain treatment challenges that continue to face people living with HIV."

About the Phase III TrialsSPRING-2 Study Design (ING113086)SPRING-2 is a Phase III, randomized, blinded, active-controlled, multicenter, parallel group, non-inferiority study. The study will include approximately 788 HIV-1 infected treatment-naive patients.  The non-inferiority study will compare efficacy and safety outcomes of '572 and raltegravir (RAL); both treatment arms will be administered with investigator-selected dual nucleoside reverse transcriptase inhibitor therapy (either ABC/3TC or TDF/FTC).

The primary objective for SPRING-2 will be to demonstrate the antiviral activity of '572 50mg administered once-daily compared to RAL 400mg administere

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