Serono reported positive results from a Phase III trial of its recombinant human growth hormone Serostim for the treatment of HIV-associated adipose redistribution syndrome at the International AIDS Conference in Toronto, Canada, yesterday.
Results of the trial formed the basis of an application to expand the indications for Serostim to include HARS that was submitted in the USA during the second quarter of 2006, and were presented for the first time in Toronto.
Called HARS 24380, the trial found that a 4mg dose of the drug given daily for 12 weeks significantly reduced visceral adipose tissue, trunk fat, blood cholesterol levels and improved quality of life scores. Meanwhile, maintenance therapy for 24 weeks with a lower dose of recombinant human growth hormone helped sustain the clinical benefits.
HARS is a condition affecting HIV patients in which fat becomes maldistributed around the body, sometimes being deposited on the upper back in what is known as a ‘buffalo hump’. In some cases fat is lost from the face and limbs as well. Overall the syndrome is seen in around a third of HIV-infected patients, according to a study published in the journal Antiviral Therapy.
Serono sells hGH under the Serostim and Saizen brand names, and its range already approved in the USA for the treatment of paediatric growth hormone deficiency, adult growth hormone deficiency, HIV wasting or cachexia and for the treatment of short bowel syndrome.
Last year the company was forced to spend $704 million to settle criminal and civil claims that it offered kickbacks to doctors in return for prescribing Serostim, which is approved for treating AIDS wasting syndrome.