CAMBRIDGE, Mass., Dec. 5 /CNW/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) announced today the initiation of a Phase II
clinical trial for VX-950, an investigational oral hepatitis C virus (HCV)
protease inhibitor for the treatment of HCV infection. The 28-day study will
evaluate the safety, tolerability and pharmacodynamics of VX-950 when combined
with pegylated interferon and ribavirin. Pegylated interferon and ribavirin
are two approved treatments for HCV infection. Twelve treatment-naive
subjects will be enrolled in the study at two centers in the United States.
This is the first clinical study of VX-950 to be initiated under an open
investigational new drug (IND) application with the United States Food and
Drug Administration, and marks the beginning of a broad Phase II clinical
development program planned 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.