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Shionogi-ViiV Healthcare extends HIV trial

Shionogi-ViiV Healthcare is to take its once-daily, unboosted investigational integrase inhibitor S/GSK1349572 into phase III clinical trials

Shionogi-ViiV Healthcare is to take its once-daily, unboosted investigational integrase inhibitor S/GSK1349572 into phase III clinical trials later this year.

Known as '572, the possible HIV treatment will be the only once-daily, unboosted integrase inhibitor in phase III clinical development.

This decision is based on promising results from two phase IIb trials, SPRING-1 and VIKING, which explored the efficacy of '572 in treatment-naive HIV subjects and in treatment-experienced subjects resistant to raltegravir. The phase III trial will determine its safety, efficacy and resistance profile.

"ViiV Healthcare is committed to developing promising new options for the treatment of HIV. As a once-daily, unboosted integrase inhibitor, '572 could be an important new therapy to help people living with HIV," stated Dr Dominique Limet, chief executive officer, ViiV Healthcare.

"'572 has the potential to offer naive and experienced patients a new option, one which in phase II has shown positive antiviral activity and resistance results once a day. We hope to explore the potential further in the phase III studies, which are expected to begin this year."

Dr Sapan Shah, president and CEO, Shionogi, said: "We are very pleased with the progress of '572 in collaboration with ViiV Healthcare. Reaching the important milestone of initiating phase III studies is a credit to the hard work and commitment of teams in both Shionogi and ViiV Healthcare. We look forward to starting the phase III programme for '572 and demonstrating its potential to benefit HIV infected patients across the treatment spectrum."

Shionogi-ViiV Healthcare is also developing second-generation integrase inhibitors, including S/GSK1265744, which is currently in phase II development.

ViiV Healthcare is a specialist HIV company set up by GlaxoSmithKline and Pfizer to develop HIV treatments. Shionogi is a research-driven pharmaceutical company headquartered in Japan dedicated to infectious diseases, pain, metabolic syndrome, allergy and cancer.

21st July 2010

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