FDAnews
www.fdanews.com/articles/67882-serono-completes-patient-enrollment-in-phase-iii-trial-of-serostim-in-hars

Serono Completes Patient Enrollment in Phase III Trial of Serostim in HARS

January 24, 2005

Serono Inc., the U.S. affiliate of global biotechnology leader Serono, has completed enrollment in its second multicenter, Phase III trial of Serostim in the treatment of HIV-Associated Adipose Redistribution Syndrome (HARS).

The primary goal of this randomized, double-blind, placebo-controlled trial is to assess whether Serostim (somatropin [rDNA origin] for injection) induction therapy significantly reduces the marked abnormal accumulation of visceral adipose tissue (intra-abdominal fat) and fat maldistribution, which characterize HARS, and whether low-dose maintenance therapy prevents the abnormalities from returning during a continued course of therapy.