AIDS
Growth Hormone Therapy trial for HIV-Associated Adipose Redistribution Syndrome(HARS) reaches Phase III
By Akanksha,Pharmacology Correspondent
Jan 24, 2005, 15:39

HIV-associated adipose redistribution syndrome or HARS is a metabolic disorder characterized by abnormalities of intermediary metabolism resulting in weight loss, inappropriate depletion of lean body mass (LBM), and paradoxical preservation of body fat.LBM includes primarily skeletal muscle, organ tissue, blood and blood constituents, and both intracellular and extracellular water. Depletion of LBM results in muscle weakness, organ failure, and death.

Serono Inc., the US affiliate of global biotechnology leader Serono, announced today that it has completed enrollment in its second multi-center, phase III trial of Serostim(R) (somatropin [rDNA origin] for injection) in the treatment of HIV-Associated Adipose Redistribution Syndrome (HARS).

Somatropin is a human growth hormone (hGH)produced by recombinant DNA technology.It is an anabolic and anticatabolic agent which exerts its influence by interacting with specific receptors on a variety of cell types including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells.Some, but not all of its effects, are mediated by insulin-like growth factor-I (IGF-I).

The primary goal of this randomized, double-blind, placebo-controlled trial is to assess whether Somatropin induction therapy significantly reduces the marked abnormal accumulation of visceral adipose tissue (intra-abdominal fat) and fat maldistribution which characterize HARS, and whether low-dose maintenance therapy prevents the abnormalities from returning during a continued course of therapy.

"We are pleased to have reached this major milestone for this very important study," said James Sapirstein, Executive Vice President of Metabolic Endocrinology at Serono, Inc. "An unmet need clearly exists in this patient population. Serono is committed to ensuring rapid completion of the trial and a US registration submission for Serostim as a treatment for this orphan indication."

Somatropin is the only growth hormone approved by the US Food and Drug Administration for the treatment of HIV wasting or cachexia. The recommended dose is 0.1 mg/kg daily (6 mg/day for patients > 55 kg). Somatropin 0.1 mg/kg every other day should be considered as a starting dose in patients thought to be at risk of certain adverse effects, e.g., glucose intolerance.

However,growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure.It is also contraindicated in patients with active neoplasia (either newly diagnosed or recurrent). It should not be administered in patients with a known hypersensitivity to growth hormone.

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Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif�, Gonal-F�, Luveris�, Ovidrel(R )/Ovitrelle�, Serostim�, Saizen�, Zorbtive(TM) and Raptiva�. In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are approximately 30 ongoing development projects.


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