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Insmed Releases Positive Results from Iplex Phase II HIV-Associated,Adipose Redistribution Syndrome Clinical Study

RICHMOND, Va.--(BUSINESS WIRE)--Apr 30, 2007 - Insmed Inc., (Nasdaq:INSM) today announced positive results from a Phase II investigator-sponsored clinical study of the company's drug IPLEX(TM) in HIV-infected patients affected with HIV-associated Adipose Redistribution Syndrome (HARS).

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.

Notably, normal glucose tolerance was restored in half of the six patients diagnosed with impaired glucose tolerance (IGT) at the start of the study. These IGT patients also experienced a significant decrease in visceral adipose tissue (VAT). Impaired glucose tolerance is characterized by blood glucose between 140 and 200 mg/dl at the 120-minute measurement of an oral glucose tolerance test. The next phase of the study is underway to explore an IPLEX dose of 1.0 mg/kg/day given for six months.

"Our study has demonstrated that a low dose of IPLEX increased IGF-I levels 3-fold and positively impacted abnormal glucose metabolism, dyslipdemia and abnormal fat distribution, which are present in a significant number of HIV patients treated with highly active antiretroviral therapy (HAART)," said Morris Schambelan, M.D., the study's principal investigator and professor of medicine and director of the General Clinical Research Centers at University of California, San Francisco, and chief of endocrinology at San Francisco General Hospital.

"We are very encouraged by t
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