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Exsulin Corporation Announces Publication of Phase 2 Trial Results for Novel Islet Regeneration Treatment in Type 1 & Type 2 Diabetes
Date:8/18/2009

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The first two phase II placebo-controlled 12-week trials - one in T1DM patients and one in T2DM patients - tested two doses of once-daily injected Exsulin and found that continued study for both T1DM and T2DM treatment is warranted. Exsulin is a hormone that is being studied for its ability to regenerate islets in the pancreas, which contain the insulin-producing beta cells. Restoration of insulin secretion could potentially reduce or eliminate the challenges of maintaining normal glucose control for all patients with T1DM and insulin dependent T2DM.

In the T1DM study (SPIRIT 1), Arginine-stimulated C-peptide (AUC0-30) significantly increased from baseline in the 600 mg group (p = 0.0058 versus placebo) while in the T2DM patients (SPIRIT 2) stimulated C-peptide was significantly better preserved in the 600 mg group 30 days after washout (p = 0.031 versus placebo). In T2DM patients, A1C decreased significantly more in the 600 mg group compared to placebo at day 90 (-0.94% versus -0.47%, respectively, p = 0.009) and day 120, 30 days after washout (-0.73% versus -0.24%, respectively, p = 0.013). This was accompanied by significant reductions in mean glucose. Placebo-adjusted A1C trended downward in T1DM patients. Stimulated C-peptide is recommended by experts as the best measure of endogenous insulin secretion and has been acknowledged by FDA to be the primary regulatory efficacy endpoint for T1DM therapies. Increasing evidence underscores that even small amounts of retained insulin secretion helps to prevent complications and serious hypoglycemia in people with T1DM.

Diabetes is a life threatening condition affecting nearly 24 million people in the United States and over 200 million worldwide. Diabetes has remained one of medicine's most significant and costly chronic diseases without a cure. By restoring natural insulin secretion, Exsulin may p
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SOURCE Exsulin Corporation
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