Vertex begins Prove 1, to begin Prove 2 studies of VX-950 for treatment of hepatitis C virus

By Lisa Kerner

Erie, Pa., May 23 - Vertex Pharmaceuticals Inc. said it began Prove 1, a four-arm, 260-patient phase 2 study of VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor.

The company also plans to begin its Prove 2, four-arm, 320-patient phase 2 study in June to assess the proportion of patients who achieve SVR, or less than 10 IU/mL HCV RNA, 24 weeks after dosing is complete.

Both studies, to be conducted in the United States and Europe, are expected to evaluate sustained viral response (SVR) rates in 580 treatment-naive patients infected with genotype 1 HCV, according to a company news release.

A phase 2b study of VX-950, planned for the second half of 2006, will evaluate about 400 patients who failed prior standard-of-care treatment.

The company said the objectives of its global phase 2 development program are 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.

Vertex expects to enroll a total of 1,000 patients in its VX-950 clinical trials by the first quarter of 2007.

"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," Prove 1 study lead investigator John McHutchison said in the release.

"Throughout this phase 2 study, we will further develop a clinical and safety database and increase our experience with VX-950 among clinicians and patients."

Vertex announced results for a 28-day, phase 2 study of VX-950 in combination with peg-IFN and RBV at the Digestive Disease Week Conference in Los Angeles. The results showed that plasma HCV RNA levels in all 12 patients were below the limit of detection at the end of 28 days of treatment with VX-950 in combination with peg-IFN and RBV.

Vertex is a biotechnology company located in Cambridge, Mass., specializing in small molecule drugs.

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