Serono reports positive data for r-hGH in HARS

27 August 2006

Swiss biotechnology firm Serono presented positive results from a pivotal Phase III trial of its recombinant human growth hormone (r-hGH) for the treatment of HIV-associated adipose redistribution syndrome (HARS) at the 16th International AIDS Conference, held in Toronto, Canada.

326 patients were randomized into the trial to determine if daily administration of r-hGH was a good treatment for HARS, which is abnormal fat accumulation and distribution associated with HARS, an increasingly prevalent phenomemon as life expectancy increases for patients with the virus.

At the end of the induction phase, the mean change (+/- SD) in visceral adipose tissue (VAT) area was -32.6 +/- 37.9cm2 on r-hGH and +0.5 +/- 34.5cm2 on placebo (p<0.001). Compared to placebo, patients on r-hGH induction therapy had decreased trunk fat, limb fat and non-high density lipoprotein cholesterol (p<0.023).

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