Serono announced this morning that it had completed an important Phase III double-blind, placebo-controlled trial on its recombinant human growth hormone. This recombinant hormone is used in the treatment of HIV related Adipose Redistribution Syndrome (HARS) which involves abnormal accumulation of fat on the trunk or deep within the abdomen.
The study involved the use of 300 patients, and its results will be used to determine if taking r-hGH for the treatment of abnormal fat accumulation in HARS will reduce Visceral Adipose Tissue better than the placebo. The first phase of the study involved patients being randomly chosen for either the placebo or the r-hGH 4mg daily group. In the second phase of the study, r-hGH was administered as 2mg every day for 2 weeks to review the maintenance process.
Serono will submit the data it has collected to the FDA in the beginning of 2006, and will also give a presentation on the data as well.