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Phase 3 trial of recombinant human growth hormone for HIV-associated HARS meets endpoints

Published in Obesity and Diabetes Week, January 30th, 2006

Serono (SEO) announced the completion of its pivotal phase 3 double-blind, placebo-controlled trial of Serono's recombinant human growth hormone in the treatment of HIV-associated adipose redistribution syndrome (HARS), which met all prespecified primary and major secondary endpoints.

Serono plans to submit the file to the FDA in the first half of 2006 and expects that the data will be presented at upcoming scientific meetings.

More than 300 patients enrolled in 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 (VAT) more...

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