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DiaMedica's DM-199 for Type 1 Diabetes significantly delays autoimmune attack and demonstrates a dramatic increase in C-Peptide levels

December 12, 2011

DiaMedica Inc. is pleased to announce new compelling Type 1 diabetes data. An in vivo study with the chronic administration of DM-199 significantly delayed the autoimmune attack, preserved beta cell mass and demonstrated a 12-fold increase in circulating C-peptide levels in the non-obese diabetic (NOD) animal model.

“The most compelling results of the study was the significant dose-dependent increase in circulating C-peptide levels, a key indicator of functional beta cells producing insulin,” stated Dr. Savinov, MD, from The Sanford Project and lead investigator of the study. “Such an unprecedented increase in C-peptide levels reflects not only improved insulin secretion, but most likely points towards DM-199’s ability to stabilize and preserve C-peptide in peripheral blood. These effects of DM-199 treatment can also provide potential benefit to patients suffering from diabetes complications such as diabetic neuropathy (nerve damage which can lead to loss of feeling and limb amputation), nephropathy (progressive kidney disease leading to failure and dialysis) and retinopathy (progressive loss of eyesight).”

“The primary endpoint in most Type 1 diabetes clinical trials is C-peptide levels,” stated Rick Pauls, President and CEO of DiaMedica. “The fact that C-peptide levels actually exceeded the normal physiological range and achieved therapeutic concentrations used in clinical studies suggests that DM-199 is a very strong clinical candidate for the treatment of Type 1 diabetes and some of its complications. C-peptide is the primary indicator of functional beta cells producing insulin, as there is a 1:1 relationship between C-peptide and insulin production.”

Additionally, the increase in C-peptide levels correlated with preserved beta cell mass, reduced insulitis (inflammation of beta cells) and increased regulatory T cell populations that suppress unwanted immune responses. . Furthermore, insulin-producing beta cells in the pancreas were still functional as good glucose control was observed and DM-199 treatment was well tolerated throughout the study (18 weeks).

The results of the DM-199 Type 1 diabetes study will be presented on December 5th 2011, at the 21st International Diabetes Federation (IDF) World Diabetes Congress (Dubai, UAE) by Dr. Alexei Savinov, MD, from The Sanford Project. The Sanford Project and DiaMedica also intend to publish the results of this study together in a peer-reviewed publication.

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“The primary endpoint in most Type 1 diabetes clinical trials is C-peptide levels,” stated Rick Pauls, President and CEO of DiaMedica. “The fact that C-peptide levels actually exceeded the normal physiological range and achieved therapeutic concentrations used in clinical studies suggests that DM-199 is a very strong clinical candidate for the treatment of Type 1 diabetes and some of its complications. C-peptide is the primary indicator of functional beta cells producing insulin, as there is a 1:1 relationship between C-peptide and insulin production.”