Insmed initiates Phase II HIV trial
Insmed has initiated a Phase II clinical trial examining the therapeutic benefit of treating HIV-associated Lipodystrophy with SomatoKine, the company's proprietary once daily IGF-I therapy.
Insmed has initiated a Phase II clinical trial examining the therapeutic benefit of treating HIV-associated Lipodystrophy with SomatoKine, the company's proprietary once daily IGF-I therapy.
The Phase II clinical trial is an open-label study designed to evaluate the safety and efficacy of SomatoKine for 12 weeks in 12 subjects with HIV associated lipodystrophy. To qualify for inclusion in the study, patients must be between 18-65 years of age, have confirmed HIV-1 infection, fat accumulation (visceral adiposity), and evidence of insulin resistance. The primary goal of the study is to determine the effects of SomatoKine on visceral fat and insulin sensitivity.
'We have made tremendous strides in treating HIV infection with highly active antiretroviral therapy. However, with these advances, we have encountered a number of troublesome side effects, including insulin resistance and abnormalities in fat distribution. We are eager to identify effective therapies for these problems, so that affected patients may return to a more normal metabolic state. In previous studies, SomatoKine has demonstrated an ability to improve both insulin sensitivity and body composition in other patient populations, and we are optimistic that those benefits will be seen in our HIV positive patients as well,' said Dr Morris Schambelan, principal investigator in the trial.
More on HIV-Associated Lipodystrophy
Since the advent of highly active antiretroviral therapy (HAART), there has been a marked increase in adverse metabolic effects, such as insulin resistance, hyperglycemia, dyslipidemia and changes in body fat distribution that include syndromes of both central fat accumulation (visceral adiposity and buffalo hump) and fat loss in the limbs. Recent studies performed in subjects on HAART suggest nearly 50% of individuals develop the morphologic features of this syndrome. With the similarity to metabolic syndrome X, which has been associated with increased risk of cardiovascular disease, it is now feared that these side effects may impact on the long-term prognosis in patients whose life expectancies have been significantly extended due to effective viral suppression by HAART.
More on rhIGF-I/rhIGFBP-3, SomatoKine
Insmed's SomatoKine is a proprietary drug product of insulin-like growth factor-I (IGF-I) and its principal binding protein, IGFBP-3. The novel compound is administered as a single daily subcutaneous injection, capable of restoring IGF-I levels into the normal range in deficient individuals. In phase II studies in diabetic subjects, SomatoKine treatment resulted in improved blood glucose control and reduced daily insulin use. In studies in children and adults with severe burn injury, SomatoKine treatment resulted in increased muscle protein synthesis and reduced inflammatory response. In studies in elderly subjects recovering from hip fracture, SomatoKine treatment resulted in improved functional activity and preserved bone mineral density.