Serono has announced that it has completed enrollment in its second multi-center, phase III trial of Serostim (somatropin [rDNA origin] for injection) 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 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.
"We are pleased to have reached this major milestone for this very important study," said James Sapirstein, Executive Vice President of Metabolic Endocrinology at Serono, Inc. "An unmet need clearly exists in this patient population. Serono is committed to ensuring rapid completion of the trial and a US registration submission for Serostim as a treatment for this orphan indication."
"More than 300 patients were enrolled in the study in only six months. The dedication of the clinical investigators, all study site personnel and our in-house study team coupled with the need and enthusiasm for this project in the HIV community led to speedy enrollment of this study," said Paul Lammers, Chief Medical Officer at Serono, Inc. "The results of this pivotal Phase III clinical trial are eagerly awaited."
HIV-associated adipose redistribution syndrome or HARS is a subset of HIV lipodystrophy. HIV-associated lipodystrophy is characterized by a variety of metabolic disturbances and body shape abnormalities that may present individually or in combination. Patients with HARS experience abnormal, pathological accumulation of adipose tissue, which may be present with or without fat depletion and/or metabolic abnormalities. In general, HARS patients accumulate excess visceral adipose tissue in the abdomen or may develop a fat pad on the upper back commonly known as a "buffalo hump."
Serostim [somatropin (rDNAorigin) for injection] is the only growth hormone approved by the US Food and Drug Administration for the treatment of HIV wasting or cachexia. The recommended dose is 0.1 mg/kg daily (6 mg/day for patients > 55 kg). Serostim 0.1 mg/kg every other day should be considered as a starting dose in patients thought to be at risk of certain adverse effects, e.g., glucose intolerance.