|By Marketwired .||
|February 19, 2014 08:30 AM EST|
MINNEAPOLIS, MINNESOTA -- (Marketwired) -- 02/19/14 -- Minneapolis, Minnesota - DiaMedica (TSX VENTURE: DMA) announced that it has filed a Registration Statement on Form 20-F to register its common shares with the United States Securities and Exchange Commission (the "SEC"). The filing is subject to review by the SEC.
"The registration of our common shares with the SEC is an important step in the process to be listed on a U.S. securities exchange," said Rick Pauls, President & CEO of DiaMedica. "Listing on a national U.S. stock exchange will enhance our exposure to the large U.S. biotech investment community."
DiaMedica's registration filing with the SEC follows successful completion of its Phase 1 program for DM199, which included 50 healthy volunteers. The Phase 1 program clearly demonstrated the safety and tolerability of DM199 along with supporting the potential for weekly dosing. Subsequently, in a single ascending dose study in Type 2 diabetic patients, DM199 showed a positive trend towards improved insulin sensitivity compared to placebo patients as measured by HOMA2-IR. HOMA2-IR is a measurement of insulin resistance, a primary component of Type 2 diabetes reflecting the body's inability to effectively process glucose leading to hyperglycemia (high blood glucose). Specifically, over the 8-day period, HOMA2-IR levels improved or stabilized in the 7 DM199 treated patients and worsened in the 3 placebo treated patients suggesting a potential insulin sensitization effect. DM199 is currently being evaluated in a Phase 2 clinical trial in 36 Type 2 diabetic patients who are sequestered over a one-month treatment period. Results from the Phase 2 study are expected in 2014.
A Form 20-F, once declared effective by the SEC, allows certain foreign issuers to register securities with the SEC pursuant to applicable U.S. securities laws.
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 clinical stage compound, DM199, is a recombinant human protein known as rhKLK1 that represents a novel approach to treating diabetes and associated complications. DiaMedica is also developing a novel monoclonal antibody, DM204 for the treatment of Type 2 diabetes, which is in preclinical development.
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