( hese preliminary results withlow-dose ...)Insmed Releases Positive Results from Iplex Phase II HIV-Associated,Adipose Redistribution Syndrome Clinical Study,Health

hese preliminary results with low-dose IPLEX. We believe a product that improves fat distribution while also improving insulin sensitivity would be a valuable therapy for this patient population, and the positive effects on insulin sensitivity observed in this study are consistent with what we observed in our previous studies with IPLEX in patients with diabetes. These results support the most important differentiating property of our product in this patient population, which is IPLEX's ability to improve glucose homeostasis. Competitor products such as TH9507 and growth hormone reportedly either do not alter glucose homeostasis or exacerbate it, respectively. When considering that up to 40% of this population has impaired glucose homeostasis, then this property of IPLEX becomes even more valuable," said Dr. Geoffrey Allan, president and Chief Executive Officer of Insmed.

Study Description

The ongoing, open-label, investigator-sponsored Phase II clinical study is designed to evaluate the safety and efficacy of IPLEX in two cohorts of subjects, the first of which received a 0.5 mg/kg/day dose and the second of which will receive 1.0 mg/kg/day dose. The primary endpoints of the study are to determine the safety and tolerability of IPLEX and its effects on visceral fat and insulin sensitivity.

About HARS

An estimated 80,000 HIV patients in the U.S. have 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. These features have increased markedly with the advent of highly active antiretroviral therapy (HAART) for HIV. Recent studies performed in subjects on HAART suggest nearly 40% of individuals develop the morphologic features characteristic of this syndrome.

About IPLEX

IPLEX was approved in the United States in December 2005 for the treatment of children with growth failure due to sev
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