Insmed has reported positive results from a phase II clinical study of Iplex in patients affected with HIV-associated adipose redistribution syndrome.
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An estimated 80,000 HIV patients in the US have HIV-associated adipose redistribution syndrome (HARS), according to published reports. This disorder is marked by abnormal metabolism, including central fat accumulation (visceral adiposity and buffalo hump) with or without fat loss in the limbs.
Preliminary results from the study, being conducted at the University of California, San Francisco, showed that three months of 0.5 mg/kg/day Iplex treatment in seven patients increased IGF-I levels 3-fold and was associated with significant improvements in fasting glucose levels, the amount of insulin secreted during an oral glucose tolerance test, and overall insulin sensitivity.
Moreover, there was a significant reduction in trunk fat and a positive downward trend in waist circumference when compared to baseline. Lipid profiles also tended to improve.
Iplex was approved in the US in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency. The drug is also being investigated for various other indications with unmet medical needs, including myotonic muscular dystrophy, retinopathy of prematurity and amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease).
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