MINNEAPOLIS, MINNESOTA -- (Marketwired) -- 04/08/13 -- DiaMedica (TSX VENTURE: DMA), is pleased to announce it has received regulatory approval to commence an anticipated 76 subject Phase I/II clinical trial for DM-199. The clinical trial, to be conducted in the Netherlands, is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of DM-199 in 36 healthy volunteers and in 40 T2D patients. Data from this trial will also support future DM-199 clinical trial regulatory filings for Type 1 and 2 diabetes and in other potential indications.
"We look forward to commencing the DM-199 clinical trial," stated Mr. Rick Pauls, Chairman & CEO, DiaMedica. "Based on pre-clinical results showing a novel dual mechanism of action (insulin sensitizer and insulin secretagogue) that improves glucose control and blood pressure, we have high hopes for this drug in improving the lives of diabetes patients."
The Phase I stage, a randomized, controlled trial to evaluate the safety, tolerability and pharmacokinetics of DM-199 in healthy volunteers, consists of both single ascending dose arms, and in multiple ascending dose for 14 days arms to assess the maximum tolerable dose. In the Phase II stage, T2D patients will initially be assessed for acute safety and efficacy in single ascending dose study via a meal tolerance test. A follow on 28-day dosing double-blinded placebo-controlled to assess the efficacy and safety of longer term DM-199 use. Efficacy endpoints will include measuring HbA1c, post-meal blood glucose, average blood glucose and glucose regulatory peptides levels over the 28-day study period.
DiaMedica Inc. (TSX VENTURE: DMA) is a 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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