Reuters Health Information (2005-05-10): Vertex reports positive data for hepatitis C drug
Drug & Device Development
Vertex reports positive data for hepatitis C drug
Last Updated: 2005-05-10 11:42:46 -0400 (Reuters Health)
NEW YORK (Reuters) - Vertex Pharmaceuticals Inc. on
Tuesday reported interim results from an early-stage trial that
indicate its experimental oral hepatitis C virus drug VX-950 was well
tolerated and demonstrated potent antiviral activity.
The study enrolled 34 patients with chronic genotype 1 hepatitis C
virus (HCV) infection who were treated for 14 days with placebo or one
of three dose regimens of VX-950. Genotype 1 HCV infection is the most
difficult strain of HCV to treat and the most prevalent strain in the
United States, Western Europe and Japan.
Patients receiving 750 mg of VX-950 every 8 hours achieved a median
reduction of the virus equivalent to a more than 10,000-fold decrease
in viral levels at the end of 14 days of treatment, Vertex said.
The company reported a median reduction in each of the other two
VX-950 dose groups at the end of 14 days of treatment, and said every
patient receiving the treatment achieved reduction in HCV levels within
the first 3 days of treatment.
Based on the results of the phase Ib clinical study, Vertex said it
plans to explore the development of VX-950 as monotherapy and in
combination with other HCV treatments.
Vertex said it expects to file an investigational new drug
application in the second half of 2005 to support phase II clinical
development of VX-950 in the United States. In collaboration with
Vertex, Mitsubishi Pharma Corp is developing VX-950 in Japan and
certain countries in Asia.
The results from the study will be presented by a clinical
investigator on May 17th at the Digestive Disease Week medical
conference in Chicago.