MINNEAPOLIS, MINNESOTA -- (Marketwired) -- 05/01/13 -- DiaMedica Inc. (TSX VENTURE: DMA) announces the commencement of its Phase I/II trial with first in human dosing of DM-199; a recombinant protein therapy for the treatment of diabetes and associated complications. As described in the April 8th 2013 press release, the study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of DM-199 in 36 healthy volunteers and in 40 Type 2 diabetic patients.
"The Phase I/II clinical trial will provide the opportunity to demonstrate the safety and potential biological activity of DM-199 in healthy volunteers and Type 2 diabetic patients during acute and longer-term use," stated Dr. Mark Robbins, Vice President, Clinical & Regulatory Affairs. "With the promising pre-clinical insulin sensitization and secretagogue activity of DM-199, we are keen to assess the anti-diabetic activity in man."
"We are very pleased with the initiation of the clinical trial of DM-199," said Rick Pauls, Chairman and CEO of DiaMedica. "We look forward to having the Phase I and single dose Phase II results from the Phase I/II clinical trial in the second half of 2013."
DiaMedica Inc. is a publicly traded (TSX VENTURE: DMA) clinical stage biopharmaceutical company focused on the discovery and development of novel therapies to treat diabetes and the complications associated with diabetes. DiaMedica's lead compound, DM-199, is a recombinant human protein that represents a novel approach to treating Type 1 and Type 2 diabetes. Based on the Company's understanding of the postprandial state, DiaMedica is also developing a novel monoclonal antibody, DM-204 for the treatment of Type 2 diabetes. Chronic treatment with DM-204 in a pre-clinical Type 2 diabetes model resulted in a significant improvement in blood glucose control as measured by HbA1c and also significant improved blood pressure and serum cholesterol levels.
The Company is listed on the TSX Venture Exchange in Canada under the trading symbol 'DMA'.
The statements made in this press release that are not historical facts contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address DiaMedica's expectations, should be considered forward-looking statements. Such statements are based on management's exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Corporation's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. The Corporation undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.
Chairman & CEO
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