Diabetes
SomatoKine(R) in Phase II Clinical Trial to Examine the Therapeutic Benefits of Treating Type A Extreme Insulin Resistance
By Insmed Incorporated
Apr 27, 2005, 09:18

Insmed Incorporated (Nasdaq: INSM) today announced that it has initiated a Phase II clinical trial examining the therapeutic benefit of treating Type A Extreme Insulin
Resistance with SomatoKine(R), the Company's proprietary once daily IGF-I therapy.

The clinical trial, led by Principal Investigator Professor David Dunger, University of Cambridge, Cambridge, U.K., is a Phase II, open-label, dose-ranging study designed to evaluate the safety and efficacy of SomatoKine for 16 weeks in 10 patients with Type A Extreme Insulin Resistance. To qualify for inclusion in the study, patients must be between 10-65 years of age and have a diagnosis of Type A insulin resistance. The primary efficacy endpoints of the trial are improvement in glycemic control, improvement in
insulin sensitivity, reduction in hemoglobin A1c and improvement in body composition.

"As there are no effective therapies for these patients and the long term prognosis of declining health is well documented, I am pleased to have the opportunity to be evaluating SomatoKine as a potential treatment to reverse
the significant insulin resistance and abnormalities in these patients," commented Professor Dunger. "Our past studies have demonstrated that with SomatoKine administration, these abnormalities can be overcome leading to an improved insulin sensitivity with ultimately better blood sugar control."

More on Insulin Resistance

Syndromes of Insulin Resistance result from genetic defects in the insulin receptor or insulin signaling pathways. In addition to insulin resistance and glucose intolerance or overt diabetes, these syndromes share a number of common features including variable degrees of hyperandrogenism, hirsutism, and dysmorphic features. Individuals with Type A insulin resistance who develop frank diabetes require large doses (more than 200 units/day) of subcutaneous insulin,
oral hypoglycemic agents and insulin sensitizers. Despite this intense regimen, glycemic control remains poor and these patients are at high risk of the complications of diabetes, such as cardiovascular disease, nephropathy,
retinopathy and neuropathy. Previous Phase II clinical trials completed with SomatoKine in diabetic patients have shown improved glycemic control, improved insulin sensitivity as well as a reduction in daily insulin consumption.

SomatoKine has Orphan Drug Designation in both the United States and Europe for Extreme Insulin Resistance.

More on rhIGF-I/rhIGFBP-3, SomatoKine(R)

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. On March 10, 2005, Insmed announced that the FDA had accepted Insmed's NDA submission for SomatoKine for the treatment of children with Growth Hormone
Insensitivity Syndrome (GHIS), and on April 13, 2005 the Company announced that the FDA had granted the GHIS NDA submission Priority Review status.

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.

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