Vertex Pharmaceuticals Incorporated has successfully completed dosing with VX-950 in a phase II, 28-day clinical study in hepatitis C virus (HCV) infected patients. The clinical trial showed that its hepatitis C treatment lowered virus levels to undetectable levels.
The 28-day, phase II clinical study enrolled 12 treatment-naive patients with genotype 1 HCV. At the end of the dosing period all the patients had undetectable levels of the hepatitis C virus.
In addition, the company has completed three-month animal toxicology studies that will support clinical studies of VX-950 of up to three months duration, informs the company release.
Iinitiation of additional phase II clinical studies in the US in patients with HCV is planned following required US FDA review of these latest non- clinical and clinical results, and FDA review of a proposed clinical study protocol. This information will be submitted to the FDA within the first quarter of 2006.
The phase II study is the third in a series of clinical trials of VX-950 in patients with HCV designed to evaluate safety, pharmacokinetics and antiviral activity, in order to guide the design of larger, longer duration phase II studies.
Vertex Pharmaceuticals Incorporated is a global biotechnology company that discovers and develops breakthrough small molecule drugs for serious diseases.