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Serono Completes Clinical Milestone in Phase
III Trial of Human Growth Hormone (Serostim) for HIV-associated
Adipose Redistribution Syndrome (HARS)
Serono Laboratories announced this week that
the company had completed the first 12-week patient treatment period
in its 36-week phase III double-blind trial of Serostim®
[somatropin (rDNA origin) for injection] in the treatment of
HIV-associated Adipose Redistribution Syndrome (HARS).
Serono initiated the Phase III trial in May
2004, and the last recruited patients have now successfully passed
this key milestone.
More than 300 patients have been randomly
assigned to receive either Serostim® 4 mg daily, or placebo. All patients were measured by CT scan to determine
if Serostim®
is more effective than placebo in reducing visceral adipose tissue (VAT).
About HARS
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.
Serostim® must be used in conjunction with
antiretroviral therapy. Full prescribing information for Serostim®,
including important safety information, is available at www.serostim.com. Serostim® is not FDA approved to treat
patients with HARS.
06/17/05
Source
Serono Laboratiories
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