Serono's r-hGH for treatment of HARS shows positive results in phase 3 trial

By Elaine Rigoli

Tampa, Fla., Aug. 17 - Serono, Inc. announced positive results of a pivotal phase 3 trial of its recombinant human growth hormone (r-hGH) for the treatment of HIV-associated adipose redistribution syndrome (HARS).

Serono had submitted a supplemental New Drug Application to the Food and Drug Administration 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. 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," chief medical officer Paul Lammers said in a news release.

The HARS study, a phase 3, double-blind, placebo-controlled study, was designed to evaluate recombinant human growth hormone as a potential therapy for reducing abnormal accumulations of visceral fat.

Serono, located in Rockland, Mass., is the U.S. affiliate of Serono SA, based in Geneva, Switzerland.

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