SERONO ANNOUNCES RESULTS FROM TRIAL OF HARS TREATMENT

Serono announced results of a Phase III trial of its recombinant human growth hormone (r-hGH) for the treatment of HIV-associated adipose redistribution syndrome (HARS) at the International AIDS Conference in Toronto.

The trial, a double-blind, placebo-controlled study, was designed to evaluate r-hGH as a potential therapy for reducing abnormal accumulations of visceral fat. In HARS study patients, r-hGH 4 mg daily for 12 weeks significantly reduced visceral adipose tissue, trunk fat and non-HDL cholesterol. Maintenance therapy for 24 weeks with a lower dose of r-hGH helped sustain the clinical benefits.

A total of 326 patients were randomized into the trial. Patients that had abnormal glucose at the time of screening into the trial were excluded from the study.

Recombinant human growth hormone is not currently approved for the treatment of HARS. Serono submitted a supplemental new drug application to the FDA during the second quarter of 2006.