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DiaMedica Inc. today announces that it has enrolled the final patient in the phase II proof of concept clinical trial of DM-83
WINNIPEG, MANITOBA, Canada | May 5, 2008 | DiaMedica Inc. (TSX VENTURE:DMA), a drug discovery and development company focused on novel treatments for Type 2 diabetes, today announces that it has enrolled the final patient in the phase II proof of concept clinical trial of DM-83.
Mr. Rick Pauls, DiaMedica's Interim President and CEO, said the twenty patient single-blind trial will demonstrate DM-83's level of effectiveness in controlling blood glucose and insulin levels in Type 2 diabetic patients after they have consumed a standard meal. Changes in insulin and glucose levels are the study's primary endpoints. Each patient will test both the effects of DM-83 as well as a placebo and therefore serve as their own control in this crossover study. All patients have now completed treatment and last patient is expect to complete the study in the second quarter with results to be analyzed and released shortly thereafter. The results of this trial will be used to optimize the design of the next stage of clinical development for DM-83.
"One of the key strengths of the Company's business platform is our ability to move drug candidates into clinical trials more quickly than traditional drug development", stated Mr. Pauls. "This is because we are using compounds that have already been approved for use in humans. The fact that DM-83 is a combination of two such compounds has allowed us to move it into a phase II trial in an expedient manner".
The inability to use insulin produced by the pancreas is a significant problem for people who suffer from Type 2 diabetes. This is demonstrated by the fact that many Type 2 diabetics have high levels of both glucose and insulin circulating in their bloodstream. DiaMedica believes that restoring insulin sensitivity and allowing the body to use its own naturally produced insulin is the key to combating this illness. Preclinical animal studies have demonstrated that DM-83 is able to restore insulin sensitivity to near pre-diabetic levels and has been shown to be safe.
Diabetes is a widespread and rapidly growing disease, affecting over 180 million people world wide with over 90% of diabetics being diagnosed with the Type 2 form of the disease. According to the World Health Organization this number is expected to double during the next 15 years while the American Diabetes Association has estimated the annual economic cost in 2007 to the United States to be $174 billion. Global sales of oral diabetes drugs total $6 billion today and are expected to climb to $11 billion by 2011.
About DM-83
DM-83 has demonstrated the ability to restore insulin sensitivity in an animal model of diabetes. The product is a novel combination of two known compounds with well established safety profiles that are used to treat other unrelated human conditions, one of which is used to improve cardiovascular conditions. Studies have shown that neither compound is able to restore insulin sensitivity on its own, while combining the two results in a synergistic effect that restores insulin sensitivity to pre-diabetic levels.
About DiaMedica
DiaMedica is developing novel treatments for various stages of type 2 diabetes. The Company recently completed a phase II clinical trial with its lead product DM-71 which demonstrated the ability to reduce HbA1c levels in man. The Company has two other drugs in its clinical pipeline, DM-83 and DM-99, which are moving through phase II proof of concept clinical studies.
SOURCE: DiaMedica Inc. |
