Serono Inc., the US affiliate of Serono, a global biotechnology leader headquartered in Geneva, announced that the company has initiated a phase III clinical trial of Serostim [somatropin (rDNA origin) for injection] as a potential treatment and maintenance therapy to reduce excess visceral fat accumulation in patients with HIV-associated Adipose Redistribution Syndrome (HARS).
HARS is a potentially debilitating medical condition experienced by people being treated for HIV for which there is currently no medical treatment. The visceral adipose tissue accumulations seen in HARS may also be associated with an adverse risk profile.
This multi-centre, randomised, double blind, placebo-controlled study of the safety and efficacy of Serostim in HARS will include approximately 300 patients at 30 clinical trial sites. The study will evaluate the effectiveness of Serostim 4mg administered daily for 12 weeks compared to placebo in reducing abdominal visceral adipose tissue while assessing, among other endpoints, patient reported outcomes. This trial will also evaluate the effect of Serostim 2mg administered on alternate days as a maintenance therapy to sustain reductions in visceral adipose tissue attained during the first 12 weeks of active therapy.
"This trial will build upon Serono's extensive experience with Serostim and we are hopeful that it will demonstrate the effectiveness of recombinant human growth hormone for this metabolic complication of HIV," said Paul Lammers, chief medical officer, Serono, Inc.
The results of previous studies suggest that Serostim may be an effective treatment for this indication. Serono, the third largest biotech company in the world, has previously reported positive findings of the Serostim for the Treatment of Adipose Redistribution Syndrome (STARS) study, a double-blind, placebo-controlled study, designed to evaluate Serostim as a potential HARS therapy.
HIV-associated adipose redistribution syndrome or HARS is a subset of HIV lipodystrophy. HIV-associated lipodystrophy is characterised by a variety of metabolic disturbances and body shape abnormalities that may present individually or in combination.
Patients with HARS experience abnormal, pathological accumulation of adipose tissue, which may be present with or without fat depletion and metabolic abnormalities. In general, HARS patients accumulate excess visceral adipose tissue in the abdomen and may develop a fat pad of on the upper back commonly known as a 'buffalo hump'.
Serostim is the only growth hormone approved by the US Food and Drug Administration for the treatment of HIV-associated wasting or cachexia.
Use of growth hormone is contraindicated in treatment of patients in intensive care units due to complications following open-heart surgery or abdominal surgery, multiple accidental trauma or acute respiratory failure, patients with active neoplasia and patients with known hypersensitivity to growth hormone. Serostim must be used in conjunction with antiretroviral therapy.