WINNIPEG, MANITOBA--(Marketwire - March 18, 2008) - DiaMedica Inc. (TSX VENTURE:DMA), a drug discovery and development company focused on novel treatments for type 2 diabetes, has announced that it enrolled the first patient in the phase II proof of concept clinical trial of DM-83.
Dr. Karl-Gunnar Hidinger, DiaMedica's President, said the single-blind trial will demonstrate DM-83's level of effectiveness in controlling the blood glucose levels in twenty Type 2 diabetics after they have consumed a 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. Treatment will be concluded in the second quarter and results will 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.
"This trial is another demonstration of the strength of our clinical development programs," said Dr. Hidinger. "We have discovered a very unique approach to treating this disease and believe we have found something quite important, as indicated by the clinical growth of our drug pipeline over the past six months."
The inability to use the 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 prediabetic levels and has been shown to be very 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.
DM-83 has demonstrated the ability to restore insulin sensitivity in a type 2 diabetes animal model. 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. Neither compound is able to restore insulin sensitivity on its own while combing the two results in a synergistic effect that restores insulin sensitivity to prediabetic levels.
DiaMedica is developing novel treatments for various stages of type 2 diabetes. The Company recently completed a successful phase IIa 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. The Company believes that a dysfunctional parasympathetic nerve signal to the liver is a key factor in the development of type 2 diabetes.
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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Kevin Richardson, Ph.D.
(204) 453-3745 (FAX)