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Serostim Improves Lean Body Mass, Physical Performance in Patients With HIV-Associated Wasting

ROCKLAND, Mass., March 31 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA)-Serono's Serostim® [somatropin (rDNA origin) for injection] improves lean body mass and physical performance in patients with HIV- associated wasting, according to study data published in the current edition of the Journal of AIDS ("Growth Hormone Improves Lean Body Mass, Physical Performance, and Quality of Life in Subjects with HIV-Associated Weight Loss or Wasting on Highly Active Antiretroviral Therapy"). (1)

HIV-associated wasting is a chronically debilitating and potentially life- threatening condition. It is a metabolic disorder that causes the loss of lean body mass, which includes muscle tissue, important body organ tissue and blood cells, and can lead to increased risk of opportunistic infections, illness, and extreme fatigue and can profoundly diminish a person's quality of life.

The present study, the largest randomized, double-blind placebo-controlled study of recombinant human growth hormone in HIV-associated wasting, confirmed the efficacy, safety and tolerability of Serostim®. The study treated 757 patients with HIV-associated wasting at US, European and other international trial sites. Participants were treated with placebo, 0.1 mg/kg Serostim® on alternate days, or 0.1mg/kg of Serostim® on a daily basis.

Over the 12-week course of therapy, Serostim® was superior to placebo in improving physical function, lean body mass and body weight and had a positive effect on patient perception of the benefits of therapy.

"People with HIV still involuntarily lose both weight and lean body mass, despite the adoption of highly antiretroviral therapy," said Joseph M. Gertner, MD, Vice President of Medical Affairs, Metabolic Endocrinology, Serono, Inc. "As demonstrated by these study results, Serostim® is the only therapy shown clinically to build body mass and improve physical function in people with HIV-associated wasting."

The result on the study's primary endpoint of cycle work output was statistically significant for the Serostim® as compared to the placebo group (p

This study also provides long-term efficacy and safety information for up to 48 weeks of Serostim® treatment in a subset of participants. When treatment was extended from 12 to 24 or 48 weeks, positive results in cycle work output and lean body mass either improved further or were maintained with continued treatment with Serostim® at both the daily and alternate day dosing.

Adverse reactions reported during this clinical trial were consistent with those included in the current product labeling.

About Serostim®

Serostim® [somatropin (rDNA origin) for injection] is the only growth hormone approved by the US Food and Drug Administration for the treatment of HIV-associated wasting or cachexia. The recommended dose is 0.1 mg/kg daily (6 mg/day for patients > 55 kg). Serostim® 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, i.e., glucose intolerance.

In patients with HIV-associated wasting, the most common adverse events associated with Serostim® therapy are mild to moderate muscle and joint pain and swelling, which occur in a dose-related manner and often subside with continued treatment or dose reduction. Cases of new onset impaired glucose intolerance, new onset Type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported in patients receiving Serostim®. Some patients develop diabetic ketacidosis and diabetic coma. In some patients, therapy with Serostim® necessitated initiation or adjustment of anti-diabetic treatment. Patients with a history of hyperglycemia or other risk factors for glucose intolerance should be monitored closely during treatment with Serostim®. Transient increases in glucose levels occur early in treatment and should be monitored.

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.

Full prescribing information for Serostim®, including important safety information, is available at http://www.serostim.com/.

Source: Serono, Inc.

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