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Recombinant Human Growth Hormone May Sustain Reductions in Excess Fat Accumulation in Patients With HARS

Rockland, Mass., Feb. 12 /PRNewswire-FirstCall/ -- Serono, Inc., the US affiliate of Serono (virt-x: SEO and NYSE: SRA), announced new clinical data on Serostim® [somatropin (rDNA origin) for injection] as a potential maintenance therapy to sustain reductions in excess visceral fat accumulation in patients with HIV-associated adipose redistribution syndrome (HARS) who had previously received Serostim®(1) induction therapy. The data was recently presented at a medical meeting on HIV and infectious diseases. HARS is a debilitating medical condition experienced by people being treated for HIV and for which there is currently no medical treatment. The visceral adipose tissue accumulation seen in HARS may be associated with an adverse risk profile.

"Based on its efficacy and safety profile, a low dose of Serostim® merits additional investigation as a maintenance therapy for HIV patients with HARS," said study lead investigator, Donald P. Kotler, M.D., St. Luke's Roosevelt Hospital, New York.

A prospective, multi-center, randomized, dose-finding extension trial evaluated the safety and efficacy of Serostim® maintenance therapy, administered at a dose of 1 or 2 mg daily, to sustain reductions in excess trunk fat in patients with HARS following treatment with Serostim® at a higher dose. Laboratory measurements of potential metabolic conditions occurring with HARS, such as lipid profiles, were also included.

Serono has previously reported positive findings of 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. The study results showed that Serostim® 4mg administered daily for 12 weeks decreased visceral adipose tissue and trunk fat as compared to placebo (p

The present trial was an extension of the STARS study. The maintenance phase involved 142 HIV positive patients with HARS and demonstrated significant reductions (p

"Serono is committed to continuing research aimed at resolving metabolic complications associated with HIV, including HARS," commented Paul Lammers, MD, MSc, Chief Medical Officer, Serono, Inc.

HIV-associated adipose redistribution syndrome or HARS is a subset of HIV lipodystrophy. HIV-associated lipodystrophy is characterized 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/or metabolic abnormalities. In general, HARS patients accumulate excess visceral adipose tissue in the abdomen or may develop a fat pad on the upper back commonly known as a "buffalo hump."

About Serostim®

Serostim® [somatropin (rDNAorigin) for injection] 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). 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, Serostim® has a generally manageable side effect profile. 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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