- HGS expects to have all Phase 3 data available by spring 2009 to support the filing of global marketing authorization applications by fall 2009 -
ROCKVILLE, Md., Nov. 1 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has completed enrollment and initial dosing ahead of schedule in ACHIEVE 2/3, the second of two pivotal global Phase 3 trials of Albuferon(R) (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with chronic hepatitis C. ACHIEVE 2/3 is being conducted in patients with genotypes 2 and 3 chronic hepatitis C.
"We are ahead of our original schedule with both Phase 3 trials of Albuferon and we expect the filing of global marketing applications by fall 2009," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "If the results of our Phase 2 trials are confirmed in Phase 3, we believe Albuferon could become the interferon of choice for the treatment of chronic hepatitis C.
ACHIEVE 2/3 enrolled 933 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. ACHIEVE 1, the first of the two Phase 3 trials, completed enrollment of 1331 treatment-naive patients with genotype 1 chronic hepatitis C in August 2007. HGS originally projected enrollment of the Phase 3 trials by the end of 2007. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006.
"Albuferon requires half as many injections as the long-acting
interferons that are currently in use," said David Nel
|SOURCE Human Genome Sciences, Inc.|
Copyright©2007 PR Newswire.
All rights reserved