ROCKLAND, Mass., Aug. 17 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA) announced today positive results of a pivotal Phase III trial of Serono's recombinant human growth hormone (r-hGH) for the treatment of HIV-associated Adipose Redistribution Syndrome (HARS) at the XVI International AIDS Conference in Toronto, Canada. Results of the trial were presented as a late-breaker session on August 17th during the International AIDS Conference. Serono submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) during the second quarter of 2006. "The findings from the HARS study provide promising news for the HIV community and for people living with HARS, a metabolic condition for which there is currently no approved drug treatment," said Paul Lammers, M.D., M.Sc., Chief Medical Officer for Serono, Inc. "Visceral fat accumulation and lipid changes are concerns for HIV patients who are living longer due to advances in antiretroviral therapy. We are pleased that the study met all pre-specified primary and major secondary efficacy endpoints and we look forward to working with the FDA during the review process." The HARS study, a Phase III, double-blind, placebo-controlled study, was designed to evaluate recombinant human growth hormone 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 (VAT), trunk fat, non-HDL cholesterol, and improved pre-specified health-related quality of life outcomes. Maintenance therapy for 24 weeks with a lower dose of r-hGH helped sustain the clinical benefits. "The results of the HARS study indicate that Serono's recombinant human growth hormone has a potential role in the treatment of HIV-infected patients who have increased visceral adipose tissue," said lead presenter and investigator, Carl Grunfeld, M.D.,PhD, Professor of Medicine, Chief, Metabolism and Endocrine Sections, SF Veterans Affairs Medical Center, University of California at San Francisco. "This is an important finding for a condition that has a significant impact on HIV-infected patients in the U.S. who suffer from the consequences of increased visceral fat." Results of the HARS Phase III Trial 326 patients were randomized into the trial to determine if daily administration of r-hGH as treatment for the abnormal fat accumulation and distribution associated with HARS reduces visceral adipose tissue as compared to placebo. Patients that had abnormal glucose at the time of screening into the trial were excluded from the study. The primary endpoint was change in cross-sectional VAT area on CT scan measured at vertebral level L4-L5. Key secondary endpoints included reduction in trunk fat, the impact of reduction in VAT on body image and patient reported outcomes associated with quality of life, and changes in lipid parameters, including non-HDL cholesterol. In the first induction phase of the study, patients were randomly assigned to receive either r-hGH 4 mg daily, or placebo for 12 weeks. In the second placebo-controlled maintenance phase of the study, r-hGH was administered as 2 mg on alternate days for 24 weeks to assess the ability of a lower dose regimen to sustain improvements in VAT. At the end of the induction phase, the mean change (plus or minus SD) in visceral adipose tissue area was -32.6 plus or minus 37.9cm2 on r-hGH and +0.5 plus or minus 34.5cm2 on placebo (p