DiaMedica Inc.

DiaMedica Inc.

March 04, 2008 09:42 ET

DiaMedica Receives Regulatory Clearance for Phase II Human Study of DM-99

WINNIPEG, MANITOBA--(Marketwire - March 4, 2008) - DiaMedica Inc. (TSX VENTURE:DMA), a drug discovery and development company focused on novel treatments for type 2 diabetes is pleased to announce that it has received regulatory clearance in the European Union to conduct a Phase II human study with DM-99 in type 2 diabetes patients.

Dr. Karl-Gunnar Hidinger, DiaMedica's President said that the decision to advance DM-99 into clinical studies was supported by very encouraging preclinical data, reported on February 11th, from the Wasserman Laboratory at the Diabetes Research and Training Center at Vanderbilt University in Nashville, Tennessee. Dr. Hidinger said that he expects the study to be completed in 2008.

"This will be a double-blind crossover study in 20 diabetic patients that will measure the change in glucose and insulin levels after a meal. In this manner the variability between patients is minimized because each patient crossing over between placebo and DM-99 treatment in effect serves as its own control" stated Dr. Hidinger. "The results of this study will give an indication as to how well DM-99 works at controlling blood glucose levels in a type 2 diabetic population and thus guide us into the next stage of clinical development".

"DiaMedica is poised for growth as we now have three drug candidates with enormous market potential in clinical development," added Dr. Hidinger. "Our pipeline of clinical stage products has a tremendous history of safe use in patients to compliment our growing body of evidence of their efficacy in the significant type 2 diabetes market".

Diabetes is a widespread and rapidly growing disease, affecting 180 million people world wide, with over 90% being diagnosed as Type 2. According to the American Diabetes Association, the total annual economic cost of diabetes to the United States in 2007 was estimated to be $174 billion with over 10% of health care dollars attributed to it. Most notably, diabetes deaths are projected to increase by over 80% in middle-upper income countries between 2006 and 2015. Global sales of oral diabetes drugs currently total $6 billion per year and are expected to climb to $11 billion per year by 2011.

DM-99 is a biological product with a well established safety profile being studied by DiaMedica for a novel use as a treatment for Type 2 diabetes. The product has demonstrated the ability to positively impact glucose metabolism in animal models.

About DiaMedica

DiaMedica is developing novel treatments for various stages of type 2 diabetes based on evidence that a dysfunctional nerve signal from the brain to the liver is responsible for 50-65% of total glucose uptake by muscle. DiaMedica's technology is focused towards restoring the function of this nerve signal and thus reversing the progression of the disease. The Company recently completed a successful phase IIa clinical trial with its lead product DM-71 that demonstrated the ability to reduce HbA1c levels with no serious adverse advents. DiaMedica has two other drugs in phase II clinical trials, DM-83 and DM-99, with results expected in each study 2008.

Caution Regarding Forward-Looking Information

Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, our anticipated future operating results, and can, in some cases, be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.

These statements reflect management's current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: DiaMedica's early stage of development, lack of product revenues and history of operating losses, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, additional financing requirements and access to capital, unproven markets, supply of raw materials, income tax matters, management of growth, partnerships for development and commercialization of technology, effects of insurers' willingness to pay for products, system failures, dependence on key personnel, foreign currency risk, risks related to regulatory matters and risks related to intellectual property and other risks detailed from time to time in DiaMedica's filings with Canadian securities regulatory authorities, as well as DiaMedica's ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, as well as under the heading "Risk Factors" contained in DiaMedica's final long-form prospectus dated March 12, 2007. DiaMedica cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on DiaMedica's forward-looking statements to make decisions with respect to DiaMedica, investors and others should carefully consider the foregoing factors and other uncertainties and potential events.

These risks and uncertainties should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, DiaMedica cannot provide assurance that actual results will be consistent with these forward-looking statements. DiaMedica undertakes no obligation to update or revise any forward-looking statement.

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

Contact Information

  • DiaMedica Inc.
    Kevin Richardson, Ph.D.
    Director, Investor Relations
    (204) 478-5605
    (204) 453-3745 (FAX)
    Email: krichardson@diamedica.com