Vertex begins phase II hepatitis study

The studies, named PROVE 1 and PROVE 2, will be conducted in the US and Europe as part of a global phase II development program for VX-950. Together, the two studies are expected to evaluate sustained viral response (SVR) rates in 580 treatment-naive patients infected with genotype 1 hepatitis C virus (HCV).

Vertex' global phase II development program in treatment-naive patients has three objectives: to evaluate the optimal SVR rate that can be achieved with VX-950 therapy in combination with the current standard of care, to evaluate the optimal treatment duration for VX-950, and to evaluate the role of ribavirin in VX-950-based therapy.

In addition to these two major studies, Vertex expects to begin additional clinical studies of VX-950 in the second half of the year, including a phase IIb study in patients who failed prior standard of care treatment. Vertex anticipates this phase IIb study to enroll approximately 400 patients.

By the end of the first quarter of 2007, Vertex expects to have enrolled approximately 1,000 patients in clinical trials of VX-950.

“PROVE 1 is the largest clinical study to date of an HCV protease inhibitor in triple combination therapy in a treatment-naive patient population, and provides us with the first opportunity to assess the potential to enhance sustained virologic response rates with a shortened treatment duration with VX-950, along with peginterferon and ribavirin,” said Dr John McHutchison, from Duke University and lead investigator for the study.