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news.Biotech firm Vertex Pharmaceuticals has initiated a phase II clinical trial for VX-950, an investigational oral hepatitis C vaccine, to study the treatment in combination with two existing therapies, pegylated interferon and ribavirin.
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The investigational hepatitis C virus (HCV) treatment is a protease inhibitor, which will be studied during a 28-day investigation to evaluate its safety, tolerability and pharmacodynamics when combined with pegylated interferon and ribavirin, two approved treatments for HCV.
Twelve treatment-naive subjects will be enrolled in the study at two centers in the US. This is the first clinical study of VX-950 to be initiated under an open investigational new drug application with the FDA, and marks the beginning of Vertex’s planned broad phase II clinical development program for VX-950 that will evaluate the compound in multiple clinical studies in 2006, including a three-month study in more than 200 treatment-naive patients.
Patients will be dosed with VX-950 at 750 mg every eight hours with standard doses of pegylated interferon and ribavirin. Vertex expects to obtain results from this initial phase II study in the first quarter of 2006.
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease. HCV affects 3.4 million people in the US according to Vertex, and is spread through direct contact with the blood of infected people.